Erratum to: Efficacy and safety of olokizumab in Asian patients with moderate-to-severe rheumatoid arthritis, previously exposed to anti-TNF therapy: Results from a randomized phase II trial (Modern Rheumatology, (2016), 26, 1, (15-23), 10.3109/14397595.2015.1074648);Efficacy and safety of olokizumab in Asian patients with moderate-to-severe rheumatoid arthritis, previously exposed to anti-TNF therapy: Results from a randomized phase II trial

Modern Rheumatology

Volumn 26, Issue 1, 2016, Pages 15-23

  Takeuchi, Tsutomu ^a   Tanaka, Yoshiya ^b   Yamanaka, Hisashi ^c   Amano, Kanzo ^d   Nagamine, Ryuji ^e   Park, Won ^f   Shiozawa, Kazuko ^g   Tsukano, Michishi ^h   Wei, James Cheng Chung ^i,j,k   Shao, Jing ^l   Togo, Osamu ^l   Mashimo, Hideki ^l  

^a KEIO UNIVERSITY   (Japan)

^b UNIVERSITY OF OCCUPATIONAL AND ENVIRONMENTAL HEALTH   (Japan)

^c TOKYO WOMEN'S MEDICAL UNIVERSITY   (Japan)

^d Hiroshima Clinic   (Japan)

^e Tokushukai Fukuoka Hospital   (Japan)

^f Inha University Hospital   (South Korea)

^g Kohnan Kakogawa Hospital   (Japan)

^h Kumamoto Orthopaedic Hospital   (Japan)

ⁱ CHUNG SHAN MEDICAL UNIVERSITY HOSPITAL   (Taiwan)

^j CHUNG SHAN MEDICAL UNIVERSITY   (Taiwan)

^k CHINA MEDICAL UNIVERSITY   (Taiwan)

^l UCB PHARMA   (Belgium)

more..

Author keywords

Anti IL6; Anti TNF therapy failures; DMARDs (biologic); Olokizumab; Rheumatoid arthritis

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; C REACTIVE PROTEIN; CORTICOSTEROID; CYCLOOXYGENASE 2 INHIBITOR; INTERLEUKIN 6; METHOTREXATE; NONSTEROID ANTIINFLAMMATORY AGENT; OLOKIZUMAB; PLACEBO; TUMOR NECROSIS FACTOR INHIBITOR; ANTIRHEUMATIC AGENT; MONOCLONAL ANTIBODY; TNF PROTEIN, HUMAN; TUMOR NECROSIS FACTOR ALPHA;

ADULT; ARTICLE; CELLULITIS; CONTROLLED CLINICAL TRIAL; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TREATMENT FAILURE; DRUG WITHDRAWAL; FATIGUE; FEMALE; FOLLOW UP; GASTROINTESTINAL DISEASE; HEADACHE; HEPATOBILIARY DISEASE; HUMAN; HYPERLIPIDEMIA; IMMUNOGENICITY; INFECTION; INJECTION SITE ERYTHEMA; INJECTION SITE REACTION; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; NAUSEA; NEUROLOGIC DISEASE; OPPORTUNISTIC INFECTION; PHASE 2 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RASH; RHEUMATOID ARTHRITIS; RHINOPHARYNGITIS; THRUSH; TOXIC HEPATITIS; TOXICITY; AGED; ARTHRITIS, RHEUMATOID; CLINICAL TRIAL; CONTROLLED STUDY; TREATMENT OUTCOME;

ADULT; AGED; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MALE; MIDDLE AGED; TREATMENT OUTCOME; TUMOR NECROSIS FACTOR-ALPHA;

EID: 84952638330     PISSN: 14397595     EISSN: 14397609     Source Type: Journal    
DOI: 10.1080/14397595.2018.1479049     Document Type: Erratum

References (34)

1. Gaujoux-Viala C, Smolen JS, Landewe R, Dougados M, Kvien TK, Mola EM, et al. Current evidence for the management of rheumatoid arthritis with synthetic disease-modifying antirheumatic drugs: A systematic literature review informing the EULAR recommendations for the management of rheumatoid arthritis. Ann Rheum Dis. 2010;69:1004-9.
2. Rubbert-Roth A, Finckh A. Treatment options in patients with rheumatoid arthritis failing initial TNF inhibitor therapy: A critical review. Arthritis Res Ther. 2009;11 Suppl 1:S1.
3. Marchesoni A, Zaccara E, Gorla R, Bazzani C, Sarzi-Puttini P, Atzeni F, et al. TNF-alpha antagonist survival rate in a cohort of rheumatoid arthritis patients observed under conditions of standard clinical practice. Ann N Y Acad Sci. 2009;1173:837-46.
4. Cohen SB, Emery P, Greenwald MW, Dougados M, Furie RA, Genovese MC, et al. Rituximab for rheumatoid arthritis refractory to anti-tumor necrosis factor therapy: Results of a multicenter, randomized, double-blind, placebo-controlled, phase III trial evaluating primary efficacy and safety at twenty-four weeks. Arthritis Rheum. 2006;54:2793-806.
5. McInnes IB, Schett G. Cytokines in the pathogenesis of rheumatoid arthritis. Nat Rev Immunol. 2007;7:429-42.
6. Genentech Inc. ACTEMRA (tocilizumab) Full prescribing information revised: 04/2013. Available from: Http://www.actemra.com/[last accessed 10 Dec 2013].
7. Dougados M, Kissel K, Sheeran T, Tak PP, Conaghan PG, Mola EM, et al. Adding tocilizumab or switching to tocilizumab monotherapy in methotrexate inadequate responders: 24-week symptomatic and structural results of a 2-year randomised controlled strategy trial in rheumatoid arthritis (ACT-RAY). Ann Rheum Dis. 2013;72:43-50.
8. Emery P, Keystone E, Tony HP, Cantagrel A, van Vollenhoven R, Sanchez A, et al. IL-6 receptor inhibition with tocilizumab improves treatment outcomes in patients with rheumatoid arthritis refractory to anti-tumour necrosis factor biologicals: Results from a 24-week multicentre randomised placebo-controlled trial. Ann Rheum Dis. 2008;67:1516-23.
9. Genovese MC, McKay JD, Nasonov EL, Mysler EF, da Silva NA, Alecock E, 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 therapy study. Arthritis Rheum. 2008;58:2968-80.
10. Hashimoto J, Garnero P, van der Heijde D, Miyasaka N, Yamamoto K, Kawai S, et al. Humanized anti-interleukin-6-receptor antibody (tocilizumab) monotherapy is more effective in slowing radiographic progression in patients with rheumatoid arthritis at high baseline risk for structural damage evaluated with levels of biomarkers, radiography, and BMI: Data from the SAMURAI study. Mod Rheumatol. 2011;21:10-15.
11. Hushaw LL, Sawaqed R, Sweis G, Reigle J, Gopal A, Brandt D, et al. Critical appraisal of tocilizumab in the treatment of moderate to severe rheumatoid arthritis. Ther Clin Risk Man. 2010;6:143-52.
12. Nakashima Y, Kondo M, Harada H, Horiuchi T, Ishinishi T, Jojima H, et al. Clinical evaluation of tocilizumab for patients with active rheumatoid arthritis refractory to anti-TNF biologics: Tocilizumab in combination with methotrexate. Mod Rheumatol. 2010;20:343-52.
13. Nishimoto N, Hashimoto J, Miyasaka N, Yamamoto K, Kawai S, Takeuchi T, et al. Study of active controlled monotherapy used for rheumatoid arthritis, an IL-6 inhibitor (SAMURAI): Evidence of clinical and radiographic benefit from an x ray reader-blinded randomised controlled trial of tocilizumab. Ann Rheum Dis. 2007;66:1162-7.
14. Nishimoto N, Miyasaka N, Yamamoto K, Kawai S, Takeuchi T, Azuma J, et al. Study of active controlled tocilizumab monotherapy for rheumatoid arthritis patients with an inadequate response to methotrexate (SATORI): Significant reduction in disease activity and serum vascular endothelial growth factor by IL-6 receptor inhibition therapy. Mod Rheumatol. 2009;19:12-19.
15. Kretsos K, Golor G, Jullion A, Hickling M, McCabe S, Shaw S, et al. Safety and pharmacokinetics of olokizumab, an anti-IL-6 monoclonal antibody, administered to healthy male volunteers: A randomized phase I study. Clin Pharmacol Drug Dev. 2014;3:388-95.
16. Fleischmann R, Kivitz AJ, Wagner F, Feinstein JA, Fuhr U, Rech J, et al. a pilot study investigating the tolerability and pharmacodynamic effect of single intravenous/subcutaneous doses of olokizumab, an anti-interleukin-6 monoclonal antibody, in patients with rheumatoid arthritis. Ann Rheum Dis. 2011;70(Suppl 3):471.
17. Genovese MC, Fleischmann R, Furst D, Janssen N, Carter J, Dasgupta B, et al. Efficacy and safety of olokizumab in patients with rheumatoid arthritis with an inadequate response to TNF inhibitor therapy: Outcomes of a randomised Phase IIb study. Ann Rheum Dis. 2014;73:1607-15.
18. Arnett FC, Edworthy SM, Bloch DA, McShane DJ, Fries JF, Cooper NS, et al. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum. 1988;31:315-24.
19. Aletaha D, Neogi T, Silman AJ, Funovits J, Felson DT, Bingham CO, III et al. 2010 rheumatoid arthritis classification criteria: An American College of Rheumatology/European League Against Rheumatism collaborative initiative. Ann Rheum Dis. 2010;69: 1580-8.
20. Matsuda Y, Singh G, Yamanaka H, Tanaka E, Urano W, Taniguchi A, et al. Validation of a Japanese version of the Stanford Health Assessment Questionnaire in 3,763 patients with rheumatoid arthritis. Arthritis Rheum. 2003;49:784-8.
21. U.S Department of Health and Human Services Food and Drug Administration. Guidance for industry: Drug-induced liver injury: Premarketing clinical evaluation. U.S Department of Health and Human Services Food and Drug Administration.; 2009. Available from: Http://www.fda.gov/downloads/Drugs/Guidance/UCM174090.pdf [last accessed 12 Aug 2015]
22. Gabay C, Emery P, van Vollenhoven R, Dikranian A, Alten R, Pavelka K, et al. Tocilizumab monotherapy versus adalimumab monotherapy for treatment of rheumatoid arthritis (ADACTA): A randomised, double-blind, controlled phase 4 trial. Lancet. 2013;381:1541-50.
23. Genovese MC, Kivitz AJ, Simon Campos JA, Rell-Bakalarska M, Fleischmann R, Jasson M, et al. Sarilumab for the treatment of moderate-to-severe rheumatoid arthritis: Results of a phase 2, randomized, double-blind, placebo-controlled, international study. ACR/ARHP Annual Scientific Meeting. Chicago 2011.
24. Hsu B, Sheng S, Weinblatt ME, Smolen JS. Results from a 2-part, proof-of-concept, dose-ranging, randomized, double-blind, placebocontrolled, phase 2 study of sirukumab, a human anti-il-6 monoclonal antibody, in patients with active rheumatoid arthritis despite methotrexate therapy. Ann Rheum Dis. 2012;71(Suppl3):61.
25. Maini RN, Taylor PC, Szechinski J, Pavelka K, Broll J, Balint G, et al. Double-blind randomized controlled clinical trial of the interleukin-6 receptor antagonist, tocilizumab, in European patients with rheumatoid arthritis who had an incomplete response to methotrexate. Arthritis Rheum. 2006;54:2817-29.
26. Mease P, Strand V, Shalamberidze L, Dimic A, Raskina T, Xu LA, et al. A phase II, double-blind, randomised, placebo-controlled study of BMS945429 (ALD518) in patients with rheumatoid arthritis with an inadequate response to methotrexate. Ann Rheum Dis. 2012; 71:1183-9.
27. Smolen JS, Landewé R, Breedveld FC, Buch M, Burmester G, Dougados M, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological diseasemodifying antirheumatic drugs: 2013 update. Ann Rheum Dis. 2014;73:492-509.
28. Hickling M, Golor G, Jullion A, Shaw S, Kretsos K. Safety and pharmacokinetics of CDP6038, an anti-IL-6 monoclonal antibody, administered by subcutaneous injection and intravenous infusion to healthy male volunteers: A phase 1 study. Ann Rheum Dis. 2011;70(Suppl 3):471.
29. Mima T, Nishimoto N. Clinical value of blocking IL-6 receptor. Curr Opin Rheumatol. 2009;21:224-30.
30. Madhok R, Crilly A, Watson J, Capell HA. Serum interleukin 6 levels in rheumatoid arthritis: Correlations with clinical and laboratory indices of disease activity. Ann Rheum Dis. 1993;52: 232-4.
31. Straub RH, Muller-Ladner U, Lichtinger T, Scholmerich J, Menninger H, Lang B. Decrease of interleukin 6 during the first 12 months is a prognostic marker for clinical outcome during 36 months treatment with disease-modifying anti-rheumatic drugs. Br J Rheumatol. 1997;36:1298-303.
32. Tanaka Y, Martin Mola E. IL-6 targeting compared to TNF targeting in rheumatoid arthritis: Studies of olokizumab, sarilumab and sirukumab. Ann Rheum Dis. 2014;73:1595-7.
33. Strand V, Burmester GR, Ogale S, Devenport J, John A, Emery P. Improvements in health-related quality of life after treatment with tocilizumab in patients with rheumatoid arthritis refractory to tumour necrosis factor inhibitors: Results from the 24-week randomized controlled RADIATE study. Rheumatology (Oxford). 2012;51:1860-9.
34. Tanaka Y, Takeuchi T, Amano K, Saito K, Hanami K, Nawata M, et al. Effect of interleukin-6 receptor inhibitor, tocilizumab, in preventing joint destruction in patients with rheumatoid arthritis showing inadequate response to TNF inhibitors. Mod Rheumatol. 2014;24:399-404.