Autoimmune diseases induced by biological agents. A review of 12,731 cases (BIOGEAS Registry)

Expert Opinion on Drug Safety

Volumn 16, Issue 11, 2017, Pages 1255-1271

  Pérez De Lis, Marta ^a   Retamozo, Soledad ^b,c,d   Flores Chávez, Alejandra ^b,e,f   Kostov, Belchin ^g   Perez Alvarez, Roberto ^h   Brito Zerón, Pilar ^b,i   Ramos Casals, Manuel ^b,j  

^a HOSPITAL JUAN CANALEJO   (Spain)

^b HOSPITAL CLÍNIC   (Spain)

^c HOSPITAL PRIVADO   (Argentina)

^d Facultad de Ciencias Naturales e Instituto M Lillo   (Argentina)

^e HOSPITAL DE ESPECIALIDADES   (Mexico)

^f UNIVERSIDAD DE COLIMA   (Mexico)

^g INSTITUT D INVESTIGACIONS BIOMÈDIQUES AUGUST PI I SUNYER IDIBAPS   (Spain)

^h Alvaro Cunqueiro Hospital   (Spain)

ⁱ Hospital CIMA Sanitas   (Spain)

^j UNIVERSITY OF BARCELONA   (Spain)

more..

Author keywords

anti TNF agents; Autoimmune disease; big data; cancer; drug induced event; growth factor inhibitors; immune checkpoint inhibitors; rituximab

Indexed keywords

ADALIMUMAB; BEVACIZUMAB; BIOLOGICAL PRODUCT; EFALIZUMAB; ETANERCEPT; INFLIXIMAB; IPILIMUMAB; NIVOLUMAB; RITUXIMAB; USTEKINUMAB; IMMUNOLOGIC FACTOR; MONOCLONAL ANTIBODY; TUMOR NECROSIS FACTOR;

ACUTE FEBRILE NEUTROPHILIC DERMATOSIS; ADRENAL DISEASE; ADRENALITIS; ALOPECIA; ATAXIA; AUTOIMMUNE DISEASE; AUTOIMMUNE HEPATITIS; AUTOIMMUNE PANCREATITIS; BIOLOGICAL THERAPY; CENTRAL SEROUS RETINOPATHY; DEMYELINATING DISEASE; DRUG SURVEILLANCE PROGRAM; ENDOPHTHALMITIS; EOSINOPHILIA; GENETIC BACKGROUND; GLOMERULONEPHRITIS; GRANULOMA ANNULARE; HEMOLYTIC ANEMIA; HUMAN; HYPOPARATHYROIDISM; HYPOPHYSITIS; IMMUNOTHERAPY; INFLAMMATORY BOWEL DISEASE; INSULIN DEPENDENT DIABETES MELLITUS; INTERSTITIAL LUNG DISEASE; INTERSTITIAL NEPHRITIS; LICHEN (DISEASE); LUPUS VULGARIS; MACULAR EDEMA; MOTOR NEUROPATHY; MYOCARDITIS; NEUROMUSCULAR DISEASE; NEUTROPENIA; ORBIT INFLAMMATION; PERICARDITIS; PERIPHERAL NEUROPATHY; PROGNOSIS; PSORIASIS; PYODERMA GANGRENOSUM; RADICULOPATHY; REGISTER; REGULATORY T LYMPHOCYTE; RETINA DISEASE; REVIEW; SARCOIDOSIS; SCLERITIS; SUPPURATIVE HIDRADENITIS; THROMBOCYTOPENIA; THROMBOSIS; THYROIDITIS; UVEITIS; VASCULITIS; VITILIGO; VOGT KOYANAGI SYNDROME; ANTAGONISTS AND INHIBITORS; AUTOIMMUNE DISEASES; CHEMICALLY INDUCED; IMMUNOLOGY;

ANTIBODIES, MONOCLONAL; AUTOIMMUNE DISEASES; BIOLOGICAL PRODUCTS; HUMANS; IMMUNOLOGIC FACTORS; TUMOR NECROSIS FACTOR-ALPHA;

EID: 85031114908     PISSN: 14740338     EISSN: 1744764X     Source Type: Journal    
DOI: 10.1080/14740338.2017.1372421     Document Type: Review

References (244)

1. Ramos-Casals M, Garcia-Hernandez FJ, de Ramon E, et al. Off-label use of rituximab in 196 patients with severe, refractory systemic autoimmune diseases. Clin Exp Rheumatol. 2010;28:468–476.
2. Ramos-Casals M, Brito-Zeron P, Munoz S, et al. Autoimmune diseases induced by TNF-targeted therapies: analysis of 233 cases. Medicine (Baltimore). 2007;86:242–251.
3. Ramos-Casals M, Roberto-Perez-Alvarez R-P, Diaz-Lagares C, et al. Autoimmune diseases induced by biological agents: a double-edged sword? Autoimmun Rev. 2010;9:188–193.
4. Perez-Alvarez R, Perez-de-Lis M, Ramos-Casals M., Biologics-induced autoimmune diseases. Curr Opin Rheumatol. 2013;25:56–64.
5. Ecker DM, Jones SD, Levine HL., The therapeutic monoclonal antibody market. MAbs. 2015;7:9–14.
6. Lonberg N, Korman AJ. Masterful antibodies: checkpoint blockade. Cancer Immunol Res. 2017;5:275–281.
7. Babouri A, Roblin X, Filippi J, et al. Tolerability of one hour 10mg/kg infliximab infusions in inflammatory bowel diseases: a prospective multicenter cohort study. J Crohns Colitis. 2014;8:161–165.
8. Burmester GR, Mariette X, Montecucco C, et al. Adalimumab alone and in combination with disease-modifying antirheumatic drugs for the treatment of rheumatoid arthritis in clinical practice: the Research in Active Rheumatoid Arthritis (ReAct) trial. Ann Rheum Dis. 2007;66:732–739.
9. Charles PJ, Smeenk RJ, de Jong J, et al. Assessment of antibodies to double-stranded DNA induced in rheumatoid arthritis patients following treatment with infliximab, a monoclonal antibody to tumor necrosis factor alpha: findings in open-label and randomized placebo-controlled trials. Arthritis Rheum. 2000;43:2383–2390.
10. Colombel J-F, Loftus EVJ, Tremaine WJ, et al. The safety profile of infliximab in patients with Crohn’s disease: the Mayo clinic experience in 500 patients. Gastroenterology. 2004;126:19–31.
11. Colombel J-F, Sandborn WJ, Panaccione R, et al. Adalimumab safety in global clinical trials of patients with Crohn’s disease. Inflamm Bowel Dis. 2009;15:1308–1319.
12. Comby E, Tanaff P, Mariotte D, et al. Evolution of antinuclear antibodies and clinical patterns in patients with active rheumatoid arthritis with longterm infliximab therapy. J Rheumatol. 2006;33:24–30.
13. Exarchou SA, Voulgari PV, Markatseli TE, et al. Immune-mediated skin lesions in patients treated with anti-tumour necrosis factor alpha inhibitors. Scand J Rheumatol. 2009;38:328–331.
14. Flendrie M, Vissers WHPM, Creemers MCW, et al. Dermatological conditions during TNF-alpha-blocking therapy in patients with rheumatoid arthritis: a prospective study. Arthritis Res Ther. 2005;7:R666–R676.
15. Freling E, Baumann C, Cuny J-F, et al. Cumulative incidence of, risk factors for, and outcome of dermatological complications of anti-TNF therapy in inflammatory bowel disease: a 14-year experience. Am J Gastroenterol. 2015;110:1186–1196.
16. Gonnet-Gracia C, Barnetche T, Richez C, et al. Anti-nuclear antibodies, anti-DNA and C4 complement evolution in rheumatoid arthritis and ankylosing spondylitis treated with TNF-alpha blockers. Clin Exp Rheumatol. 2008;26:401–407.
17. Jani M, Dixon WG, Kersley-Fleet L, et al. Drug-specific risk and characteristics of lupus and vasculitis-like events in patients with rheumatoid arthritis treated with TNFi: results from BSRBR-RA. RMD Open. 2017;3:e000314.
18. Menter A, Feldman SR, Weinstein GD, et al. A randomized comparison of continuous vs. intermittent infliximab maintenance regimens over 1 year in the treatment of moderate-to-severe plaque psoriasis. J Am Acad Dermatol. 2007;56:31.e1-e15.
19. Nancey S, Blanvillain E, Parmentier B, et al. Infliximab treatment does not induce organ-specific or nonorgan-specific autoantibodies other than antinuclear and anti-double-stranded DNA autoantibodies in Crohn’s disease. Inflamm Bowel Dis. 2005;11:986–991.
20. Poulalhon N, Begon E, Lebbe C, et al. A follow-up study in 28 patients treated with infliximab for severe recalcitrant psoriasis: evidence for efficacy and high incidence of biological autoimmunity. Br J Dermatol. 2007;156:329–336.
21. Takase K, Horton SC, Ganesha A, et al. What is the utility of routine ANA testing in predicting development of biological DMARD-induced lupus and vasculitis in patients with rheumatoid arthritis? Data from a single-centre cohort. Ann Rheum Dis. 2014;73:1695–1699.
22. Verma HD, Scherl EJ, Jacob VE, et al. Anti-nuclear antibody positivity and the use of certolizumab in inflammatory bowel disease patients who have had arthralgias or lupus-like reactions from infliximab or adalimumab. J Dig Dis. 2011;12:379–383.
23. Guarneri C, Lentini M, Polimeni G, et al. Ustekinumab-induced drug eruption resembling lymphocytic infiltration (of Jessner-Kanof) and lupus erythematosus tumidus. Br J Clin Pharmacol. 2016;81:792–794.
24. Richez C, Dumoulin C, Schaeverbeke T. Infliximab induced chilblain lupus in a patient with rheumatoid arthritis. J Rheumatol. 2005;32:760–761.
25. Sohl S, Renner R, Winter U, et al. [Drug-induced lupus erythematosus tumidus during treatment with adalimumab]. Hautarzt. 2009;60:826–829. German.
26. Caramaschi P, Ravagnani V, Bambara LM, et al. Is the family history positive for SLE a predisposing factor for anti-TNFalpha blockers induced lupus? A case report. Joint Bone Spine. 2010;77:484–485.
27. Beigel F, Schnitzler F, Paul Laubender R, et al. Formation of antinuclear and double-strand DNA antibodies and frequency of lupus-like syndrome in anti-TNF-alpha antibody-treated patients with inflammatory bowel disease. Inflamm Bowel Dis. 2011;17:91–98.
28. Pontikaki I, Shahi E, Frasin LA, et al. Skin manifestations induced by TNF-alpha inhibitors in juvenile idiopathic arthritis. Clin Rev Allergy Immunol. 2012;42:131–134.
29. Sokumbi O, Wetter DA, Makol A, et al. Vasculitis associated with tumor necrosis factor-alpha inhibitors. Mayo Clin Proc. 2012;87:739–745.
30. Tarkiainen M, Tynjala P, Vahasalo P, et al. Occurrence of adverse events in patients with JIA receiving biologic agents: long-term follow-up in a real-life setting. Rheumatology (Oxford). 2015;54:1170–1176.
31. Guignard S, Gossec L, Bandinelli F, et al. Comparison of the clinical characteristics of vasculitis occurring during anti-tumor necrosis factor treatment or not in rheumatoid arthritis patients. A systematic review of 2707 patients, 18 vasculitis. Clin Exp Rheumatol. 2008;26:S23–S29.
32. Belkhir R, Le Burel S, Dunogeant L, et al. Rheumatoid arthritis and polymyalgia rheumatica occurring after immune checkpoint inhibitor treatment. Ann Rheum Dis. 2017. doi: 10.1136/annrheumdis-2017211216.
33. Le Burel S, Champiat S, Mateus C, et al. Prevalence of immune-related systemic adverse events in patients treated with anti-Programmed cell Death 1/anti-Programmed cell Death-Ligand 1 agents: a single-centre pharmacovigilance database analysis. Eur J Cancer. 2017;82:34–44.
34. Kip KE, Swoger JM, Grandinetti LM, et al. Tumor necrosis factor alpha antagonist-associated psoriasis in inflammatory diseases: an analysis of the FDA adverse event reporting system. Inflamm Bowel Dis. 2013;19:1164–1172.
35. Afzali A, Wheat CL, Hu JK, et al. The association of psoriasiform rash with anti-tumor necrosis factor (anti-TNF) therapy in inflammatory bowel disease: a single academic center case series. J Crohns Colitis. 2014;8:480–488.
36. Aslanidis S, Pyrpasopoulou A, Douma S, et al. Tumor necrosis factor-a antagonist-induced psoriasis: yet another paradox in medicine. Clin Rheumatol. 2008;27:377–380.
37. Baumgart DC, Grittner U, Steingraber A, et al. Frequency, phenotype, outcome, and therapeutic impact of skin reactions following initiation of adalimumab therapy: experience from a consecutive cohort of inflammatory bowel disease patients. Inflamm Bowel Dis. 2011;17:2512–2520.
38. Cleynen I, van Moerkercke W, Billiet T, et al. Characteristics of skin lesions associated with anti-tumor necrosis factor therapy in patients with inflammatory bowel disease: a cohort study. Ann Intern Med. 2016;164:10–22.
39. Dalkilic E, Bulbul Baskan E, Alkis N, et al. Tumor necrosis factor-alpha antagonist therapy-induced psoriasis in Turkey: analysis of 514 patients. Mod Rheumatol. 2012;22:738–742.
40. Fouache D, Goeb V, Massy-Guillemant N, et al. Paradoxical adverse events of anti-tumour necrosis factor therapy for spondyloarthropathies: a retrospective study. Rheumatology (Oxford). 2009;48:761–764.
41. George LA, Gadani A, Cross RK, et al. Psoriasiform skin lesions are caused by anti-TNF agents used for the treatment of inflammatory bowel disease. Dig Dis Sci. 2015;60:3424–3430.
42. Guerra I, Algaba A, Perez-Calle JL, et al. Induction of psoriasis with anti-TNF agents in patients with inflammatory bowel disease: a report of 21 cases. J Crohns Colitis. 2012;6:518–523.
43. Guerra I, Perez-Jeldres T, Iborra M, et al. Incidence, clinical characteristics, and management of psoriasis induced by anti-TNF therapy in patients with inflammatory bowel disease: a nationwide cohort study. Inflamm Bowel Dis. 2016;22:894–901.
44. Harrison MJ, Dixon WG, Watson KD, et al. Rates of new-onset psoriasis in patients with rheumatoid arthritis receiving anti-tumour necrosis factor alpha therapy: results from the British Society for Rheumatology Biologics Register. Ann Rheum Dis. 2009;68:209–215.
45. Hellstrom AE, Farkkila M, Kolho K-L. Infliximab-induced skin manifestations in patients with inflammatory bowel disease. Scand J Gastroenterol. 2016;51:563–571.
46. Hwang SJE, Carlos G, Wakade D, et al. Cutaneous adverse events (AEs) of anti-programmed cell death (PD)-1 therapy in patients with metastatic melanoma: a single-institution cohort. J Am Acad Dermatol. 2016;74:455–61.e1.
47. Lee -H-H, Song I-H, Friedrich M, et al. Cutaneous side-effects in patients with rheumatic diseases during application of tumour necrosis factor-alpha antagonists. Br J Dermatol. 2007;156:486–491.
48. Protic M, Schoepfer A, Yawalkar N, et al. Development of psoriasis in IBD patients under TNF-antagonist therapy is associated neither with anti-TNF-antagonist antibodies nor trough levels. Scand J Gastroenterol. 2016;51:1482–1488.
49. Thomas L, Canoui-Poitrine F, Gottenberg J-E, et al. Incidence of new-onset and flare of preexisting psoriasis during rituximab therapy for rheumatoid arthritis: data from the French AIR registry. J Rheumatol. 2012;39:893–898.
50. Tillack C, Ehmann LM, Friedrich M, et al. Anti-TNF antibody-induced psoriasiform skin lesions in patients with inflammatory bowel disease are characterised by interferon-gamma-expressing Th1 cells and IL-17A/IL-22-expressing Th17 cells and respond to anti-IL-12/IL-23 antibody treatment. Gut. 2014;63:567–577.
51. Hofmann L, Forschner A, Loquai C, et al. Cutaneous, gastrointestinal, hepatic, endocrine, and renal side-effects of anti-PD-1 therapy. Eur J Cancer. 2016;60:190–209.
52. Ten Tusscher MPM, Jacobs PJC, Busch MJWM, et al. Bilateral anterior toxic optic neuropathy and the use of infliximab. Bmj. 2003;326:579.
53. Kaltsonoudis E, Zikou AK, Voulgari PV, et al. Neurological adverse events in patients receiving anti-TNF therapy: a prospective imaging and electrophysiological study. Arthritis Res Ther. 2014;16:R125.
54. Corrie PG, Marshall A, Dunn JA, et al. Adjuvant bevacizumab in patients with melanoma at high risk of recurrence (AVAST-M): preplanned interim results from a multicentre, open-label, randomised controlled phase 3 study. Lancet Oncol. 2014;15:620–630.
55. Winthrop KL, Chen L, Fraunfelder FW, et al. Initiation of anti-TNF therapy and the risk of optic neuritis: from the safety assessment of biologic ThERapy (SABER) Study. Am J Ophthalmol. 2013;155:183–189.e1.
56. Fautrel B, Sibilia J, Mariette X, et al. Tumour necrosis factor alpha blocking agents in refractory adult Still’s disease: an observational study of 20 cases. Ann Rheum Dis. 2005;64:262–266.
57. Voskens CJ, Goldinger SM, Loquai C, et al. The price of tumor control: an analysis of rare side effects of anti-CTLA-4 therapy in metastatic melanoma from the ipilimumab network. PLoS One. 2013;8:e53745.
58. Deepak P, Stobaugh DJ, Sherid M, et al. Neurological events with tumour necrosis factor alpha inhibitors reported to the Food and Drug Administration Adverse Event Reporting System. Aliment Pharmacol Ther. 2013;38:388–396.
59. Tsouni P, Bill O, Truffert A, et al. Anti-TNF alpha medications and neuropathy. J Peripher Nerv Syst. 2015;20:397–402.
60. O’Toole A, Lucci M, Korzenik J. Inflammatory bowel disease provoked by etanercept: report of 443 possible cases combined from an IBD referral center and the FDA. Dig Dis Sci. 2016;61:1772–1774.
61. Barthel D, Ganser G, Kuester R-M, et al. Inflammatory bowel disease in juvenile idiopathic arthritis patients treated with biologics. J Rheumatol. 2015;42:2160–2165.
62. Braun J, Baraliakos X, Listing J, et al. Differences in the incidence of flares or new onset of inflammatory bowel diseases in patients with ankylosing spondylitis exposed to therapy with anti-tumor necrosis factor alpha agents. Arthritis Rheum. 2007;57:639–647.
63. Gerloni V, Pontikaki I, Gattinara M, et al. Focus on adverse events of tumour necrosis factor alpha blockade in juvenile idiopathic arthritis in an open monocentric long-term prospective study of 163 patients. Ann Rheum Dis. 2008;67:1145–1152.
64. Gold R, Radue E-W, Giovannoni G, et al. Safety and efficacy of daclizumab in relapsing-remitting multiple sclerosis: 3-year results from the SELECTED open-label extension study. BMC Neurol. 2016;16:117.
65. Johnson DB, Sullivan RJ, Ott PA, et al. Ipilimumab therapy in patients with advanced melanoma and preexisting autoimmune disorders. JAMA Oncol. 2016;2:234–240.
66. Klotsche J, Niewerth M, Haas J-P, et al. Long-term safety of etanercept and adalimumab compared to methotrexate in patients with juvenile idiopathic arthritis (JIA). Ann Rheum Dis. 2016;75:855–861.
67. van Dijken TD, Vastert SJ, Gerloni VM, et al. Development of inflammatory bowel disease in patients with juvenile idiopathic arthritis treated with etanercept. J Rheumatol. 2011;38:1441–1446.
68. Weber J, Thompson JA, Hamid O, et al. A randomized, double-blind, placebo-controlled, phase II study comparing the tolerability and efficacy of ipilimumab administered with or without prophylactic budesonide in patients with unresectable stage III or IV melanoma. Clin Cancer Res. 2009;15:5591–5598.
69. Cossburn M, Pace AA, Jones J, et al. Autoimmune disease after alemtuzumab treatment for multiple sclerosis in a multicenter cohort. Neurology. 2011;77:573–579.
70. Quartier P, Taupin P, Bourdeaut F, et al. Efficacy of etanercept for the treatment of juvenile idiopathic arthritis according to the onset type. Arthritis Rheum. 2003;48:1093–1101.
71. Flaig T, Douros A, Bronder E, et al. Tocilizumab-induced pancreatitis: case report and review of data from the FDA Adverse Event Reporting System. J Clin Pharm Ther. 2016;41:718–721.
72. Alabed YZ, Aghayev A, Sakellis C, et al. Pancreatitis secondary to anti-programmed death receptor 1 immunotherapy diagnosed by FDG PET/CT. Clin Nucl Med. 2015;40:e528–e529.
73. Ikeuchi K, Okuma Y, Tabata T. Immune-related pancreatitis secondary to nivolumab in a patient with recurrent lung adenocarcinoma: a case report. Lung Cancer. 2016;99:148–150.
74. Abdulkader R, Dharmapalaiah C, Rose G, et al. Late-onset neutropenia in patients with rheumatoid arthritis after treatment with rituximab. J Rheumatol. 2014;41:858–861.
75. Aguiar-Bujanda D, Blanco-Sanchez MJ, Hernanten Tusscherz-Sosa M, et al. Late-onset neutropenia after rituximab-containing therapy for non-Hodgkin lymphoma. Clin Lymphoma Myeloma Leuk. 2015;15:761–765.
76. Albattal BM. Tocilizumab efficacy and safety in rheumatoid arthritis patients after inadequate response to disease-modifying anti-rheumatic drugs or anti-tumor necrosis factor. Ann Saudi Med. 2016;36:190–196.
77. Ansell SM, Hurvitz SA, Koenig PA, et al. Phase I study of ipilimumab, an anti-CTLA-4 monoclonal antibody, in patients with relapsed and refractory B-cell non-Hodgkin lymphoma. Clin Cancer Res. 2009;15:6446–6453.
78. Arai Y, Yamashita K, Mizugishi K, et al. Risk factors for late-onset neutropenia after rituximab treatment of B-cell lymphoma. Hematology. 2015;20:196–202.
79. Aslanidis S, Pyrpasopoulou A, Triantafyllou A, et al. Tumor necrosis factor antagonist-associated neutropenia: comment on the article by Hastings et al. Arthritis Care Res (Hoboken). 2010;62:1813–1815.
80. Burmester GR, Lin Y, Patel R, et al. Efficacy and safety of sarilumab monotherapy versus adalimumab monotherapy for the treatment of patients with active rheumatoid arthritis (MONARCH): a randomised, double-blind, parallel-group phase III trial. Ann Rheum Dis. 2017;76:840–847.
81. Cattaneo C, Spedini P, Casari S, et al. Delayed-onset peripheral blood cytopenia after rituximab: frequency and risk factor assessment in a consecutive series of 77 treatments. Leuk Lymphoma. 2006;47:1013–1017.
82. Chaiwatanatorn K, Lee N, Grigg A, et al. Delayed-onset neutropenia associated with rituximab therapy. Br J Haematol. 2003;121:913–918.
83. Ciancio G, Gaynor JJ, Sageshima J, et al. Randomized trial of dual antibody induction therapy with steroid avoidance in renal transplantation. Transplantation. 2011;92:1348–1357.
84. De Benedetti F, Brunner HI, Ruperto N, et al. Randomized trial of tocilizumab in systemic juvenile idiopathic arthritis. N Engl J Med. 2012;367:2385–2395.
85. Devauchelle-Pensec V, Berthelot JM, Cornec D, et al. Efficacy of first-line tocilizumab therapy in early polymyalgia rheumatica: a prospective longitudinal study. Ann Rheum Dis. 2016;75:1506–1510.
86. Di Giacomo AM, Ascierto PA, Pilla L, et al. Ipilimumab and fotemustine in patients with advanced melanoma (NIBIT-M1): an open-label, single-arm phase 2 trial. Lancet Oncol. 2012;13:879–886.
87. Dijkgraaf EM, Santegoets SJAM, Reyners AKL, et al. A phase I trial combining carboplatin/doxorubicin with tocilizumab, an anti-IL-6R monoclonal antibody, and interferon-alpha2b in patients with recurrent epithelial ovarian cancer. Ann Oncol Off J Eur Soc Med Oncol. 2015;26:2141–2149.
88. Dy GK, Molina JR, Qi Y, et al. NCCTG N0821 (Alliance): a phase II first-line study of pemetrexed, carboplatin, and bevacizumab in elderly patients with advanced nonsquamous non-small-cell lung cancer with good performance status. J Thorac Oncol. 2014;9:1146–1153.
89. Espinoza F, Le Blay P, Combe B. Biologic disease-modifying antirheumatic drug (bDMARD)-induced neutropenia: a registry from a retrospective cohort of patients with rheumatic diseases treated with 3 classes of intravenous bDMARD. J Rheumatol. 2017;44:844–849.
90. Fujinaga S, Ozawa K, Sakuraya K, et al. Late-onset adverse events after a single dose of rituximab in children with complicated steroid-dependent nephrotic syndrome. Clin Nephrol. 2016;85:340–345.
91. Fukuno K, Tsurumi H, Ando N, et al. Late-onset neutropenia in patients treated with rituximab for non-Hodgkin’s lymphoma. Int J Hematol. 2006;84:242–247.
92. Genovese MC, Cohen S, Moreland L, et al. Combination therapy with etanercept and anakinra in the treatment of patients with rheumatoid arthritis who have been treated unsuccessfully with methotrexate. Arthritis Rheum. 2004;50:1412–1419.
93. Godinho F, Godfrin B, El Mahou S, et al. Safety of leflunomide plus infliximab combination therapy in rheumatoid arthritis. Clin Exp Rheumatol. 2004;22:328–330.
94. Guglieri-Lopez B, Perez-Pitarch A, Porta Oltra B, et al. Effectiveness, toxicity, and economic evaluation of ipilimumab for the treatment of patients with metastatic melanoma in the Spanish outpatient setting. Anticancer Drugs. 2016;27:679–684.
95. Hirayama Y, Kohda K, Konuma Y, et al. Late onset neutropenia and immunoglobulin suppression of the patients with malignant lymphoma following autologous stem cell transplantation with rituximab. Intern Med. 2009;48:57–60.
96. Hong YS, Lee SS, Kim K, et al. A phase II study of bevacizumab, oxaliplatin, and capecitabine in patients with previously untreated metastatic colorectal cancer: a prospective, multicenter trial of the Korean Cancer Study Group. Am J Clin Oncol. 2014;37:19–23.
97. Horinouchi H, Yamamoto N, Fujiwara Y, et al. Phase I study of ipilimumab in phased combination with paclitaxel and carboplatin in Japanese patients with non-small-cell lung cancer. Invest New Drugs. 2015;33:881–889.
98. Illei GG, Shirota Y, Yarboro CH, et al. Tocilizumab in systemic lupus erythematosus: data on safety, preliminary efficacy, and impact on circulating plasma cells from an open-label phase I dosage-escalation study. Arthritis Rheum. 2010;62:542–552.
99. Ishida H, Inui M, Furusawa M, et al. Late-onset neutropenia (LON) after low-dose rituximab treatment in living related kidney transplantation–single-center study. Transpl Immunol. 2013;28:93–99.
100. Jones G, Sebba A, Gu J, et al. Comparison of tocilizumab monotherapy versus methotrexate monotherapy in patients with moderate to severe rheumatoid arthritis: the AMBITION study. Ann Rheum Dis. 2010;69:88–96.
101. Jones RB, Ferraro AJ, Chaudhry AN, et al. A multicenter survey of rituximab therapy for refractory antineutrophil cytoplasmic antibody-associated vasculitis. Arthritis Rheum. 2009;60:2156–2168.
102. Kahl BS, Hong F, Williams ME, et al. Rituximab extended schedule or re-treatment trial for low-tumor burden follicular lymphoma: eastern cooperative oncology group protocol e4402. J Clin Oncol. 2014;32:3096–3102.
103. Kamei K, Takahashi M, Fuyama M, et al. Rituximab-associated agranulocytosis in children with refractory idiopathic nephrotic syndrome: case series and review of literature. Nephrol Dial Transplant. 2015;30:91–96.
104. Kang HJ, Lee -S-S, Byun BH, et al. Repeated radioimmunotherapy with 131I-rituximab for patients with low-grade and aggressive relapsed or refractory B cell non-Hodgkin lymphoma. Cancer Chemother Pharmacol. 2013;71:945–953.
105. Kindler HL, Friberg G, Singh DA, et al. Phase II trial of bevacizumab plus gemcitabine in patients with advanced pancreatic cancer. J Clin Oncol. 2005;23:8033–8040.
106. Kivitz A, Wallace T, Olech E, et al. Long-term safety and efficacy of subcutaneously administered tocilizumab for adult rheumatoid arthritis: a multicenter phase 3b long-term extension study. Rheumatol Ther. 2016;3:291–304.
107. Knight A, Sundström Y, Börjesson O, et al. Late-onset neutropenia after rituximab in ANCA-associated vasculitis. Scand J Rheumatol. 2016;45:404–407.
108. Lai GGY, Lim S-T, Tao M, et al. Late-onset neutropenia following RCHOP chemotherapy in diffuse large B-cell lymphoma. Am J Hematol. 2009;84:414–417.
109. Langer CJ, Gadgeel SM, Borghaei H, et al. Carboplatin and pemetrexed with or without pembrolizumab for advanced, non-squamous non-small-cell lung cancer: a randomised, phase 2 cohort of the open-label KEYNOTE-021 study. Lancet Oncol. 2016;17:1497–1508.
110. Le Stradic C, Galeotti C, Kone-Paut I. [Tocilizumab: experience in a French rheumatological pediatric center]. Arch Pediatr. 2014;21:1299–1304. French.
111. Lehman TJ, Singh C, Ramanathan A, et al. Prolonged improvement of childhood onset systemic lupus erythematosus following systematic administration of rituximab and cyclophosphamide. Pediatr Rheumatol Online J. 2014;12:3.
112. Leon L, Vázquez S, Gracia JM, et al. First-line bevacizumab, cisplatin and vinorelbine plus maintenance bevacizumab in advanced non-squamous non-small cell lung cancer chemo-naive patients. Expert Opin Pharmacother. 2012;13:1389–1396.
113. Levälampi T, Korpela M, Vuolteenaho K, et al. Etanercept and adalimumab treatment in patients with rheumatoid arthritis and spondyloarthropathies in clinical practice: adverse events and other reasons leading to discontinuation of the treatment. Rheumatol Int. 2008;28:261–269.
114. Li S-C, Chen Y-C, Evens AM, et al. Rituximab-induced late-onset neutropenia in newly diagnosed B-cell lymphoma correlates with Fc receptor FcgammaRIIIa 158(V/F) polymorphism. Am J Hematol. 2010;85:810–812.
115. Lindegaard HM, Johansen P, Gröndal G, et al. Doubling the single-dose infusion rate of tocilizumab in rheumatoid arthritis is safe and efficacious. Scand J Rheumatol. 2016;45:262–266.
116. Loricera J, Blanco R, Hernandez JL, et al. Tocilizumab in giant cell arteritis: multicenter open-label study of 22 patients. Semin Arthritis Rheum. 2015;44:717–723.
117. Loricera J, Blanco R, Castañeda S, et al. Tocilizumab in refractory aortitis: study on 16 patients and literature review. Clin Exp Rheumatol. 2014;32:S79–S89.
118. Madan RA, Mohebtash M, Arlen PM, et al. Ipilimumab and a poxviral vaccine targeting prostate-specific antigen in metastatic castration-resistant prostate cancer: a phase 1 dose-escalation trial. Lancet Oncol. 2012;13:501–508.
119. Malhotra B, Evans T, Weiss J, et al. Carboplatin/pemetrexed/bevacizumab in the treatment of patients with advanced non-small-cell lung cancer: a single-institution experience. Clin Lung Cancer. 2010;11:192–197.
120. Mallett A, Hughes P, Szer J, et al. Atypical haemolytic uraemic syndrome treated with the complement inhibitor eculizumab: the experience of the Australian compassionate access cohort. Intern Med J. 2015;45:1054–1065.
121. McIver Z, Stephens N, Grim A, et al. Rituximab administration within 6 months of T cell-depleted allogeneic SCT is associated with prolonged life-threatening cytopenias. Biol Blood Marrow Transplant. 2010;16:1549–1556.
122. Miyamoto Y, Tsuji A, Tanioka H, et al. S-1 and irinotecan plus bevacizumab as second-line chemotherapy for patients with oxaliplatin-refractory metastatic colorectal cancer: a multicenter phase II study in Japan (KSCC1102). Int J Clin Oncol. 2016;21:705–712.
123. Moiseev SV, Novikov PI, Semenkova EN, et al. [Severe adverse events from treatment with genetically engineered biological agents in patients with rheumatic diseases]. Ter Arkh. 2013;85:37–43. Russian.
124. Monk JP, Phillips G, Waite R, et al. Assessment of tumor necrosis factor alpha blockade as an intervention to improve tolerability of dose-intensive chemotherapy in cancer patients. J Clin Oncol. 2006;24:1852–1859.
125. Munemoto Y, Kanda M, Ishibashi K, et al. Capecitabine and oxaliplatin combined with bevacizumab are feasible for treating selected Japanese patients at least 75 years of age with metastatic colorectal cancer. BMC Cancer. 2015;15:786.
126. Nagamine R, Chen W, Hara T, et al. Immediate reduction of white blood cell count after tocilizumab administration was observed in some cases. Mod Rheumatol. 2009;19:348–350.
127. Narváez J, Díaz-Torné C, Magallares B, et al. Comparative effectiveness of tocilizumab with either methotrexate or leflunomide in the treatment of rheumatoid arthritis. PLoS One. 2015;10:e0123392.
128. Néel A, Henry B, Barbarot S, et al. Long-term effectiveness and safety of interleukin-1 receptor antagonist (anakinra) in Schnitzler’s syndrome: a French multicenter study. Autoimmun Rev. 2014;13:1035–1041.
129. Ogata Y, Shimokawa M, Tanaka T, et al. A prospective study of XELOX plus bevacizumab as first-line therapy in Japanese patients with metastatic colorectal cancer (KSCC 0902). Int J Clin Oncol. 2016;21:335–343.
130. O’Neil BH, Cainap C, Van Cutsem E, et al. Randomized phase II open-label study of mFOLFOX6 in combination with linifanib or bevacizumab for metastatic colorectal cancer. Clin Colorectal Cancer. 2014;13:156–163.e2.
131. Ortiz-Sanjuan F, Blanco R, Riancho-Zarrabeitia L, et al. Efficacy of anakinra in refractory adult-onset still’s disease: multicenter study of 41 patients and literature review. Medicine (Baltimore). 2015;94:e1554.
132. Ou W, Li N, Wang S-Y, et al. Phase 2 trial of neoadjuvant bevacizumab plus pemetrexed and carboplatin in patients with unresectable stage III lung adenocarcinoma (GASTO 1001). Cancer. 2016;122:740–747.
133. Park W, Yoo DH, Jaworski J, et al. Comparable long-term efficacy, as assessed by patient-reported outcomes, safety and pharmacokinetics, of CT-P13 and reference infliximab in patients with ankylosing spondylitis: 54-week results from the randomized, parallel-group PLANETAS study. Arthritis Res Ther. 2016;18:25.
134. Patel JD, Hensing TA, Rademaker A, et al. Phase II study of pemetrexed and carboplatin plus bevacizumab with maintenance pemetrexed and bevacizumab as first-line therapy for nonsquamous non-small-cell lung cancer. J Clin Oncol. 2009;27:3284–3289.
135. Pendergraft WF, 3rd, Cortazar FB, Wenger J, et al. Long-term maintenance therapy using rituximab-induced continuous B-cell depletion in patients with ANCA vasculitis. Clin J Am Soc Nephrol. 2014;9:736–744.
136. Perry ME, Stirling A, Hunter JA. Effect of etanercept on serum amyloid A protein (SAA) levels in patients with AA amyloidosis complicating inflammatory arthritis. Clin Rheumatol. 2008;27:923–925.
137. Ribas A, Puzanov I, Dummer R, et al. Pembrolizumab versus investigator-choice chemotherapy for ipilimumab-refractory melanoma (KEYNOTE-002): a randomised, controlled, phase 2 trial. Lancet Oncol. 2015;16:908–918.
138. Ringelstein M, Ayzenberg I, Harmel J, et al. Long-term therapy with interleukin 6 receptor blockade in highly active neuromyelitis optica spectrum disorder. JAMA Neurol. 2015;72:756–763.
139. Rios-Fernández R, Gutierrez-Salmerón MT, Callejas-Rubio J-L, et al. Late-onset neutropenia following rituximab treatment in patients with autoimmune diseases. Br J Dermatol. 2007;157:1271–1273.
140. Rozman S, Sonc M, Novakovic BJ. Late-onset neutropenia following primary treatment of diffuse large B-cell lymphoma with rituximab-containing therapy. Leuk Lymphoma. 2012;53:1945–1948.
141. Salmon JH, Cacoub P, Combe B, et al. Late-onset neutropenia after treatment with rituximab for rheumatoid arthritis and other autoimmune diseases: data from the AutoImmunity and Rituximab registry. RMD Open. 2015;1:e000034.
142. Silpa-Archa S, Oray M, Preble JM, et al. Outcome of tocilizumab treatment in refractory ocular inflammatory diseases. Acta Ophthalmol. 2016;94:e400–e406.
143. Spigel DR, Hainsworth JD, Shipley DL, et al. A randomized phase II trial of pemetrexed/gemcitabine/bevacizumab or pemetrexed/carboplatin/bevacizumab in the first-line treatment of elderly patients with advanced non-small cell lung cancer. J Thorac Oncol. 2012;7:196–202.
144. Stamatopoulos K, Papadaki T, Pontikoglou C, et al. Lymphocyte subpopulation imbalances, bone marrow hematopoiesis and histopathology in rituximab-treated lymphoma patients with late-onset neutropenia. Leukemia. 2008;22:1446–1449.
145. Tesfa D, Ajeganova S, Hägglund H, et al. Late-onset neutropenia following rituximab therapy in rheumatic diseases: association with B lymphocyte depletion and infections. Arthritis Rheum. 2011;63:2209–2214.
146. Tesfa D, Gelius T, Sander B, et al. Late-onset neutropenia associated with rituximab therapy: evidence for a maturation arrest at the (pro)myelocyte stage of granulopoiesis. Med Oncol. 2008;25:374–379.
147. Thueringer JT, Doll NK, Gertner E. Anakinra for the treatment of acute severe gout in critically ill patients. Semin Arthritis Rheum. 2015;45:81–85.
148. Unizony S, Arias-Urdaneta L, Miloslavsky E, et al. Tocilizumab for the treatment of large-vessel vasculitis (giant cell arteritis, Takayasu arteritis) and polymyalgia rheumatica. Arthritis Care Res (Hoboken). 2012;64:1720–1729.
149. Vlahovic G, Meadows KL, Uronis HE, et al. A phase I study of bevacizumab, everolimus and panitumumab in advanced solid tumors. Cancer Chemother Pharmacol. 2012;70:95–102.
150. Weber JS, D’Angelo SP, Minor D, et al. Nivolumab versus chemotherapy in patients with advanced melanoma who progressed after anti-CTLA-4 treatment (CheckMate 037): a randomised, controlled, open-label, phase 3 trial. Lancet Oncol. 2015;16:375–384.
151. Wu C, Fernandez SA, Criswell T, et al. Disrupting cytokine signaling in pancreatic cancer: a phase I/II study of etanercept in combination with gemcitabine in patients with advanced disease. Pancreas. 2013;42:813–818.
152. Yamasaki M, Murakami I, Nakano K, et al. Carboplatin plus weekly paclitaxel combined with bevacizumab as first-line treatment for non-small cell lung cancer. Anticancer Res. 2017;37:923–928.
153. Yoshinami T, Yagi T, Okuno J, et al. Efficacy and safety of re-induction therapy with bevacizumab and paclitaxel for metastatic breast cancer. Breast Cancer. 2017;24:147–151.
154. Younes A, Santoro A, Shipp M, et al. Nivolumab for classical Hodgkin’s lymphoma after failure of both autologous stem-cell transplantation and brentuximab vedotin: a multicentre, multicohort, single-arm phase 2 trial. Lancet Oncol. 2016;17:1283–1294.
155. Genovese MC, McKay JD, Nasonov EL, et al. Interleukin-6 receptor inhibition with tocilizumab reduces disease activity in rheumatoid arthritis with inadequate response to disease-modifying antirheumatic drugs: the tocilizumab in combination with traditional disease-modifying antirheumatic drug the. Arthritis Rheum. 2008;58:2968–2980.
156. Rajakulendran S, Deighton C. Adverse dermatological reactions in rheumatoid arthritis patients treated with etanercept, an anti-TNFalpha drug. Curr Drug Saf. 2006;1:259–264.
157. Abou-Jaoude MM, Ghantous I, Almawi WY. Comparison of daclizumab, an interleukin 2 receptor antibody, to anti-thymocyte globulin-Fresenius induction therapy in kidney transplantation. Mol Immunol. 2003;39:1083–1088.
158. Atteno M, Peluso R, Costa L, et al. Comparison of effectiveness and safety of infliximab, etanercept, and adalimumab in psoriatic arthritis patients who experienced an inadequate response to previous disease-modifying antirheumatic drugs. Clin Rheumatol. 2010;29:399–403.
159. Calvo-Rio V, Santos-Gomez M, Calvo I, et al. Anti-interleukin-6 receptor tocilizumab for severe juvenile idiopathic arthritis-associated uveitis refractory to anti-tumor necrosis factor therapy: a multicenter study of twenty-five patients. Arthritis Rheumatol (Hoboken NJ). 2017;69:668–675.
160. Chang GJ, Mahanty HD, Vincenti F, et al. A calcineurin inhibitor-sparing regimen with sirolimus, mycophenolate mofetil, and anti-CD25 mAb provides effective immunosuppression in kidney transplant recipients with delayed or impaired graft function. Clin Transplant. 2000;14:550–554.
161. Chen M, Holland MJ, Mir MR, et al. Frequency of thrombocytopenia in psoriasis patients treated with tumor necrosis factor-a inhibitors. J Drugs Dermatol. 2011;10:280–284.
162. Cuker A, Coles AJ, Sullivan H, et al. A distinctive form of immune thrombocytopenia in a phase 2 study of alemtuzumab for the treatment of relapsing-remitting multiple sclerosis. Blood. 2011;118:6299–6305.
163. Danielli R, Ridolfi R, Chiarion-Sileni V, et al. Ipilimumab in pretreated patients with metastatic uveal melanoma: safety and clinical efficacy. Cancer Immunol Immunother. 2012;61:41–48.
164. den Broeder AA, de Jong E, Franssen MJAM, et al. Observational study on efficacy, safety, and drug survival of anakinra in rheumatoid arthritis patients in clinical practice. Ann Rheum Dis. 2006;65:760–762.
165. Elimelakh M, Dayton V, Park KS, et al. Red cell aplasia and autoimmune hemolytic anemia following immunosuppression with alemtuzumab, mycophenolate, and daclizumab in pancreas transplant recipients. Haematologica. 2007;92:1029–1036.
166. Giezen TJ, Mantel-Teeuwisse AK, Ten Berg MJ, et al. Rituximab-induced thrombocytopenia: a cohort study. Eur J Haematol. 2012;89:256–266.
167. Gonzalez-Martin A, Gladieff L, Tholander B, et al. Efficacy and safety results from OCTAVIA, a single-arm phase II study evaluating front-line bevacizumab, carboplatin and weekly paclitaxel for ovarian cancer. Eur J Cancer. 2013;49:3831–3838.
168. Hong DS, Garrido-Laguna I, Ekmekcioglu S, et al. Dual inhibition of the vascular endothelial growth factor pathway: a phase 1 trial evaluating bevacizumab and AZD2171 (cediranib) in patients with advanced solid tumors. Cancer. 2014;120:2164–2173.
169. Loricera J, Blanco R, Hernandez JL, et al. Tocilizumab in patients with Takayasu arteritis: a retrospective study and literature review. Clin Exp Rheumatol. 2016;34:S44–S53.
170. Mahalingam D, Malik L, Beeram M, et al. Phase II study evaluating the efficacy, safety, and pharmacodynamic correlative study of dual antiangiogenic inhibition using bevacizumab in combination with sorafenib in patients with advanced malignant melanoma. Cancer Chemother Pharmacol. 2014;74:77–84.
171. Odia Y, Shih JH, Kreisl TN, et al. Bevacizumab-related toxicities in the National Cancer Institute malignant glioma trial cohort. J Neurooncol. 2014;120:431–440.
172. Papo M, Bielefeld P, Vallet H, et al. Tocilizumab in severe and refractory non-infectious uveitis. Clin Exp Rheumatol. 2014;32:S75–S79.
173. Pontikaki I, Gerloni V, Gattinara M, et al. [Side effects of anti-TNFalpha therapy in juvenile idiopathic arthritis]. Reumatismo. 2006;58:31–38. Italian.
174. Reda G, Maura F, Gritti G, et al. Low-dose alemtuzumab-associated immune thrombocytopenia in chronic lymphocytic leukemia. Am J Hematol. 2012;87:936–937.
175. Sharma P, Callahan MK, Bono P, et al. Nivolumab monotherapy in recurrent metastatic urothelial carcinoma (CheckMate 032): a multicentre, open-label, two-stage, multi-arm, phase 1/2 trial. Lancet Oncol. 2016;17:1590–1598.
176. Smith CH, Jackson K, Bashir SJ, et al. Infliximab for severe, treatment-resistant psoriasis: a prospective, open-label study. Br J Dermatol. 2006;155:160–169.
177. Wolff D, Roessler V, Steiner B, et al. Treatment of steroid-resistant acute graft-versus-host disease with daclizumab and etanercept. Bone Marrow Transplant. 2005;35:1003–1010.
178. Zheng JJ, Zhi P, Wang YM, et al. Short-term study of infliximab treatment for Crohn’s disease in China. J Dig Dis. 2011;12:105–109.
179. Zheng -J-J, Wang Y-M, Zhu F, et al. [A study of efficacy of infliximab treatment for Crohn’s disease]. Zhonghua Nei Ke Za Zhi. 2009;48:922–925.
180. Vermeire S, Noman M, van Assche G, et al. Autoimmunity associated with anti-tumor necrosis factor alpha treatment in Crohn’s disease: a prospective cohort study. Gastroenterology. 2003;125:32–39.
181. Midaglia L, Rodriguez Ruiz M, Munoz-Garcia D. Severe haematological complications during treatment with natalizumab. Mult Scler. 2012;18:1644–1646.
182. Matsuno O. Drug-induced interstitial lung disease: mechanisms and best diagnostic approaches. Respir Res. 2012;13:39.
183. Hadjinicolaou AV, Nisar MK, Parfrey H, et al. Non-infectious pulmonary toxicity of rituximab: a systematic review. Rheumatology (Oxford). 2012;51:653–662.
184. Nishino M, Giobbie-Hurder A, Hatabu H, et al. Incidence of programmed cell death 1 inhibitor-related pneumonitis in patients with advanced cancer: a systematic review and meta-analysis. JAMA Oncol. 2016;2:1607–1616.
185. Koike T, Harigai M, Inokuma S, et al. Postmarketing surveillance of the safety and effectiveness of etanercept in Japan. J Rheumatol. 2009;36:898–906.
186. Takeuchi T, Tatsuki Y, Nogami Y, et al. Postmarketing surveillance of the safety profile of infliximab in 5000 Japanese patients with rheumatoid arthritis. Ann Rheum Dis. 2008;67:189–194.
187. Emery P, Fleischmann R, Filipowicz-Sosnowska A, et al. The efficacy and safety of rituximab in patients with active rheumatoid arthritis despite methotrexate treatment: results of a phase IIB randomized, double-blind, placebo-controlled, dose-ranging trial. Arthritis Rheum. 2006;54:1390–1400.
188. Furie R, Toder K, Zapantis E. Lessons learned from the clinical trials of novel biologics and small molecules in lupus nephritis. Semin Nephrol. 2015;35:509–520.
189. Hadjinicolaou AV, Nisar MK, Bhagat S, et al. Non-infectious pulmonary complications of newer biological agents for rheumatic diseases–a systematic literature review. Rheumatology (Oxford). 2011;50:2297–2305.
190. Kato T, Masuda N, Nakanishi Y, et al. Nivolumab-induced interstitial lung disease analysis of two phase II studies patients with recurrent or advanced non-small-cell lung cancer. Lung Cancer. 2017;104:111–118.
191. Nakashita T, Ando K, Kaneko N, et al. Potential risk of TNF inhibitors on the progression of interstitial lung disease in patients with rheumatoid arthritis. BMJ Open. 2014;4:e005615.
192. Nishimoto N, Miyasaka N, Yamamoto K, et al. Long-term safety and efficacy of tocilizumab, an anti-IL-6 receptor monoclonal antibody, in monotherapy, in patients with rheumatoid arthritis (the STREAM study): evidence of safety and efficacy in a 5-year extension study. Ann Rheum Dis. 2009;68:1580–1584.
193. Mihara M, Nishimoto N, Ohsugi Y. The therapy of autoimmune diseases by anti-interleukin-6 receptor antibody. Expert Opin Biol Ther. 2005;5:683–690.
194. Salmasi G, Li M, Sivabalasundaram V, et al. Incidence of pneumonitis in patients with non-Hodgkin lymphoma receiving chemoimmunotherapy with rituximab. Leuk Lymphoma. 2015;56:1659–1664.
195. Smolen JS, Beaulieu A, Rubbert-Roth A, et al. Effect of interleukin-6 receptor inhibition with tocilizumab in patients with rheumatoid arthritis (OPTION study): a double-blind, placebo-controlled, randomised trial. Lancet (London England). 2008;371:987–997.
196. Tokunaga M, Saito K, Kawabata D, et al. Efficacy of rituximab (anti-CD20) for refractory systemic lupus erythematosus involving the central nervous system. Ann Rheum Dis. 2007;66:470–475.
197. Nishino M, Ramaiya NH, Awad MM, et al. PD-1 inhibitor-related pneumonitis in advanced cancer patients: radiographic patterns and clinical course. Clin Cancer Res. 2016;22:6051–6060.
198. Johnson BE, Kabbinavar F, Fehrenbacher L, et al. ATLAS: randomized, double-blind, placebo-controlled, phase IIIB trial comparing bevacizumab therapy with or without erlotinib, after completion of chemotherapy, with bevacizumab for first-line treatment of advanced non-small-cell lung cancer. J Clin Oncol. 2013;31:3926–3934.
199. Huang Y-C, Liu C-J, Liu C-Y, et al. Low absolute lymphocyte count and addition of rituximab confer high risk for interstitial pneumonia in patients with diffuse large B-cell lymphoma. Ann Hematol. 2011;90:1145–1151.
200. Albarel F, Gaudy C, Castinetti F, et al. Long-term follow-up of ipilimumab-induced hypophysitis, a common adverse event of the anti-CTLA-4 antibody in melanoma. Eur J Endocrinol. 2015;172:195–204.
201. Brilli L, Danielli R, Ciuoli C, et al. Prevalence of hypophysitis in a cohort of patients with metastatic melanoma and prostate cancer treated with ipilimumab. Endocrine. 2017. DOI:10.1007/s12020-017-1289-2
202. Faje AT, Sullivan R, Lawrence D, et al. Ipilimumab-induced hypophysitis: a detailed longitudinal analysis in a large cohort of patients with metastatic melanoma. J Clin Endocrinol Metab. 2014;99:4078–4085.
203. Ryder M, Callahan M, Postow MA, et al. Endocrine-related adverse events following ipilimumab in patients with advanced melanoma: a comprehensive retrospective review from a single institution. Endocr Relat Cancer. 2014;21:371–381.
204. Yang JC, Hughes M, Kammula U, et al. Ipilimumab (anti-CTLA4 antibody) causes regression of metastatic renal cell cancer associated with enteritis and hypophysitis. J Immunother. 2007;30:825–830.
205. Attia P, Phan GQ, Maker AV, et al. Autoimmunity correlates with tumor regression in patients with metastatic melanoma treated with anti-cytotoxic T-lymphocyte antigen-4. J Clin Oncol. 2005;23:6043–6053.
206. Blansfield JA, Beck KE, Tran K, et al. Cytotoxic T-lymphocyte-associated antigen-4 blockage can induce autoimmune hypophysitis in patients with metastatic melanoma and renal cancer. J Immunother. 2005;28:593–598.
207. Brahmer JR, Tykodi SS, Chow LQM, et al. Safety and activity of anti-PD-L1 antibody in patients with advanced cancer. N Engl J Med. 2012;366:2455–2465.
208. Camacho LH, Antonia S, Sosman J, et al. Phase I/II trial of tremelimumab in patients with metastatic melanoma. J Clin Oncol. 2009;27:1075–1081.
209. Chen C-H, Chen H-A, Wang H-P, et al. Pulmonary arterial hypertension in autoimmune diseases: an analysis of 19 cases from a medical center in northern Taiwan. J Microbiol Immunol Infect. 2006;39:162–168.
210. Di Giacomo AM, Danielli R, Calabro L, et al. Ipilimumab experience in heavily pretreated patients with melanoma in an expanded access program at the University Hospital of Siena (Italy). Cancer Immunol Immunother. 2011;60:467–477.
211. Downey SG, Klapper JA, Smith FO, et al. Prognostic factors related to clinical response in patients with metastatic melanoma treated by CTL-associated antigen-4 blockade. Clin Cancer Res. 2007;13:6681–6688.
212. Fong L, Kwek SS, O’Brien S, et al. Potentiating endogenous antitumor immunity to prostate cancer through combination immunotherapy with CTLA4 blockade and GM-CSF. Cancer Res. 2009;69:609–615.
213. Hersh EM, O’Day SJ, Powderly J, et al. A phase II multicenter study of ipilimumab with or without dacarbazine in chemotherapy-naive patients with advanced melanoma. Invest New Drugs. 2011;29:489–498.
214. Hodi FS, O’Day SJ, McDermott DF, et al. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med. 2010;363:711–723.
215. Kirkwood JM, Lorigan P, Hersey P, et al. Phase II trial of tremelimumab (CP-675,206) in patients with advanced refractory or relapsed melanoma. Clin Cancer Res. 2010;16:1042–1048.
216. Ku GY, Yuan J, Page DB, et al. Single-institution experience with ipilimumab in advanced melanoma patients in the compassionate use setting: lymphocyte count after 2 doses correlates with survival. Cancer. 2010;116:1767–1775.
217. Lynch TJ, Bondarenko I, Luft A, et al. Ipilimumab in combination with paclitaxel and carboplatin as first-line treatment in stage IIIB/IV non-small-cell lung cancer: results from a randomized, double-blind, multicenter phase II study. J Clin Oncol. 2012;30:2046–2054.
218. Maker AV, Phan GQ, Attia P, et al. Tumor regression and autoimmunity in patients treated with cytotoxic T lymphocyte-associated antigen 4 blockade and interleukin 2: a phase I/II study. Ann Surg Oncol. 2005;12:1005–1016.
219. Maker AV, Yang JC, Sherry RM, et al. Intrapatient dose escalation of anti-CTLA-4 antibody in patients with metastatic melanoma. J Immunother. 2006;29:455–463.
220. Margolin K, Ernstoff MS, Hamid O, et al. Ipilimumab in patients with melanoma and brain metastases: an open-label, phase 2 trial. Lancet Oncol. 2012;13:459–465.
221. Min L, Hodi FS, Giobbie-Hurder A, et al. Systemic high-dose corticosteroid treatment does not improve the outcome of ipilimumab-related hypophysitis: a retrospective cohort study. Clin Cancer Res. 2015;21:749–755.
222. Phan GQ, Yang JC, Sherry RM, et al. Cancer regression and autoimmunity induced by cytotoxic T lymphocyte-associated antigen 4 blockade in patients with metastatic melanoma. Proc Natl Acad Sci U S A. 2003;100:8372–8377.
223. Ralph C, Elkord E, Burt DJ, et al. Modulation of lymphocyte regulation for cancer therapy: a phase II trial of tremelimumab in advanced gastric and esophageal adenocarcinoma. Clin Cancer Res. 2010;16:1662–1672.
224. Reck M, Bondarenko I, Luft A, et al. Ipilimumab in combination with paclitaxel and carboplatin as first-line therapy in extensive-disease-small-cell lung cancer: results from a randomized, double-blind, multicenter phase 2 trial. Ann Oncol Off J Eur Soc Med Oncol. 2013;24:75–83.
225. Ribas A, Camacho LH, Lopez-Berestein G, et al. Antitumor activity in melanoma and anti-self responses in a phase I trial with the anti-cytotoxic T lymphocyte-associated antigen 4 monoclonal antibody CP-675,206. J Clin Oncol. 2005;23:8968–8977.
226. Baughman RP, Lower EE. Who dies from sarcoidosis and why? Am J Respir Crit Care Med. 2011;183:1446–1447.
227. Royal RE, Levy C, Turner K, et al. Phase 2 trial of single agent ipilimumab (anti-CTLA-4) for locally advanced or metastatic pancreatic adenocarcinoma. J Immunother. 2010;33:828–833.
228. Small EJ, Tchekmedyian NS, Rini BI, et al. A pilot trial of CTLA-4 blockade with human anti-CTLA-4 in patients with hormone-refractory prostate cancer. Clin Cancer Res. 2007;13:1810–1815.
229. Topalian SL, Drake CG, Pardoll DM. Targeting the PD-1/B7-H1(PD-L1) pathway to activate anti-tumor immunity. Curr Opin Immunol. 2012;24:207–212.
230. van den Eertwegh AJM, Versluis J, van den Berg HP, et al. Combined immunotherapy with granulocyte-macrophage colony-stimulating factor-transduced allogeneic prostate cancer cells and ipilimumab in patients with metastatic castration-resistant prostate cancer: a phase 1 dose-escalation trial. Lancet Oncol. 2012;13:509–517.
231. Weber JS, O’Day S, Urba W, et al. Phase I/II study of ipilimumab for patients with metastatic melanoma. J Clin Oncol. 2008;26:5950–5956.
232. Delivanis DA, Gustafson MP, Bornschlegl S, et al. Pembrolizumab-induced thyroiditis. Comprehensive clinical review and insights into underlying involved mechanisms. J Clin Endocrinol Metab. 2017. DOI:10.1210/jc.2017-00448
233. Coates LC, McGonagle DG, Bennett AN, et al. Uveitis and tumour necrosis factor blockade in ankylosing spondylitis. Ann Rheum Dis. 2008;67:729–730.
234. Foeldvari I, Becker I, Horneff G. Uveitis events during adalimumab, etanercept, and methotrexate therapy in juvenile idiopathic arthritis: data from the Biologics in Pediatric Rheumatology Registry. Arthritis Care Res (Hoboken). 2015;67:1529–1535.
235. Saurenmann RK, Levin AV, Feldman BM, et al. Risk of new-onset uveitis in patients with juvenile idiopathic arthritis treated with anti-TNFalpha agents. J Pediatr. 2006;149:833–836.
236. Scrivo R, Spadaro A, Spinelli FR, et al. Uveitis following the use of tumor necrosis factor alpha inhibitors: comment on the article by Lim et al. Arthritis Rheum. 2008;58:1555–1556; author reply 1556–1557.
237. Johnson DB, Sullivan RJ, Menzies AM. Immune checkpoint inhibitors in challenging populations. Cancer. 2017;123:1904–1911.
238. Boutros C, Tarhini A, Routier E, et al. Safety profiles of anti-CTLA-4 and anti-PD-1 antibodies alone and in combination. Nat Rev Clin Oncol. 2016;13:473–486.
239. Bayry J, Siberil S, Triebel F, et al. Rescuing CD4+CD25+ regulatory T-cell functions in rheumatoid arthritis by cytokine-targeted monoclonal antibody therapy. Drug Discov Today. 2007;12:548–552.
240. Wendling D, Vidon C, Godfrin-Valnet M, et al. Exacerbation of combined pulmonary fibrosis and emphysema syndrome during tocilizumab therapy for rheumatoid arthritis. Joint Bone Spine. 2013;80:670–671.
241. Brito-Zeron P, Perez-Alvarez R, Ramos-Casals M. Etanercept and uveitis: friends or foes? Curr Med Res Opin. 2015;31:251–252.
242. Ramos-Casals M, Brito-Zerón P, Soto MJ, et al. Autoimmune diseases induced by TNF-targeted therapies. Best Pract Res Clin Rheumatol. 2008;22:847–861.
243. Ramos-Casals M, Brito-Zeron P, Cuadrado M-J, et al. Vasculitis induced by tumor necrosis factor-targeted therapies. Curr Rheumatol Rep. 2008;10:442–448.
244. Kumar V, Chaudhary N, Garg M, et al. Current diagnosis and management of immune related adverse events (irAEs) induced by immune checkpoint inhibitor therapy. Front Pharmacol. 2017;8:49.