Effectiveness and safety of tocilizumab in achieving clinical and functional remission, and sustaining efficacy in biologics-naive patients with rheumatoid arthritis: The FIRST Bio study

Modern Rheumatology

Volumn 27, Issue 2, 2017, Pages 217-226

  Ishiguro, Naoki ^a   Atsumi, Tatsuya ^b   Harigai, Masayoshi ^c   Mimori, Tsuneyo ^d   Nishimoto, Norihiro ^e   Sumida, Takayuki ^f   Takeuchi, Tsutomu ^g   Tanaka, Yoshiya ^h   Nakasone, Ayako ⁱ   Takagi, Nobuhiro ⁱ   Yamanaka, Hisashi ^j  

^a NAGOYA UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^b HOKKAIDO UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

^c TOKYO MEDICAL AND DENTAL UNIVERSITY   (Japan)

^d KYOTO UNIVERSITY   (Japan)

^e TOKYO MEDICAL UNIVERSITY   (Japan)

^f UNIVERSITY OF TSUKUBA   (Japan)

^g KEIO UNIVERSITY   (Japan)

^h UNIVERSITY OF OCCUPATIONAL AND ENVIRONMENTAL HEALTH   (Japan)

ⁱ CHUGAI PHARMACEUTICAL CO LTD   (Japan)

^j TOKYO WOMEN'S MEDICAL UNIVERSITY   (Japan)

more..

Author keywords

Biologics naive; Intravenous; Rheumatoid arthritis; Tocilizumab

Indexed keywords

C REACTIVE PROTEIN; GLUCOCORTICOID; INTERLEUKIN 6; METHOTREXATE; TOCILIZUMAB; ANTIRHEUMATIC AGENT; BIOLOGICAL PRODUCT; MONOCLONAL ANTIBODY;

ADOLESCENT; ADULT; AGED; ANGINA PECTORIS; AORTA ANEURYSM; ARTICLE; ATYPICAL MYCOBACTERIOSIS; CELLULITIS; CLINICAL DISEASE ACTIVITY INDEX; CLINICAL OBSERVATION; COMORBIDITY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DAS28; DIGESTIVE SYSTEM PERFORATION; DISEASE DURATION; DISEASE SEVERITY; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; ENTERITIS; FEMALE; GASTROINTESTINAL INFECTION; HEALTH ASSESSMENT QUESTIONNAIRE; HEART DISEASE; HEMORRHAGIC SHOCK; HEPATOBILIARY DISEASE; HERPES ZOSTER; HUMAN; INFECTION; INTERSTITIAL LUNG DISEASE; MAJOR CLINICAL STUDY; MALE; PHASE 1 CLINICAL TRIAL (TOPIC); PNEUMONIA; PRIORITY JOURNAL; PROSPECTIVE STUDY; QUALITY OF LIFE; REMISSION; RHEUMATOID ARTHRITIS; SEPSIS; SINGLE BLIND PROCEDURE; STOMACH CANCER; TREATMENT OUTCOME; URINARY TRACT INFECTION; ARTHRITIS, RHEUMATOID; COMBINATION DRUG THERAPY; MIDDLE AGED; VERY ELDERLY; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; BIOLOGICAL PRODUCTS; DRUG THERAPY, COMBINATION; FEMALE; GLUCOCORTICOIDS; HUMANS; MALE; METHOTREXATE; MIDDLE AGED; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84978516357     PISSN: 14397595     EISSN: 14397609     Source Type: Journal    
DOI: 10.1080/14397595.2016.1206507     Document Type: Article

References (42)

1. Emery P, Breedveld FC, Hall S, Durez P, Chang DJ, Robertson D, et al. Comparison of methotrexate monotherapy with a combination of methotrexate and etanercept in active, early, moderate to severe rheumatoid arthritis (COMET):a randomised, double-blind, parallel treatment trial. Lancet. 2008;372:375–82.
2. 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.
3. Jones G, Sebba A, Gu J, Lowenstein MB, Calvo A, Gomez-Reino JJ, 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.
4. Kremer JM, Blanco R, Brzosko M, Burgos-Vargas R, Halland AM, Vernon E, et al. Tocilizumab inhibits structural joint damage in rheumatoid arthritis patients with inadequate responses to methotrexate:results from the double-blind treatment phase of a randomized placebo-controlled trial of tocilizumab safety and prevention of structural joint damage at one year. Arthritis Rheum. 2011;63:609–21.
5. Smolen JS, Beaulieu A, Rubbert-Roth A, Ramos-Remus C, Rovensky J, Alecock E, 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. 2008;371:987–97.
6. 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.
7. 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;19:12–9.
8. Koike T, Harigai M, Inokuma S, Ishiguro N, Ryu J, Takeuchi T, et al. Effectiveness and safety of tocilizumab:postmarketing surveillance of 7901 patients with rheumatoid arthritis in Japan. J Rheumatol. 2014;41:15–23.
9. Yamamoto K, Goto H, Hirao K, Nakajima A, Origasa H, Tanaka K, et al. Longterm safety of tocilizumab:results from 3 years of followup postmarketing surveillance of 5573 patients with rheumatoid arthritis in Japan. J Rheumatol. 2015;42:1368–75.
10. Aletaha D, Neogi T, Silman AJ, Funovits J, Felson DT, Bingham CO, 3rd, et al. 2010 rheumatoid arthritis classification criteria:an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheum. 2010;62:2569–81.
11. Koike R, Harigai M, Atsumi T, Amano K, Kawai S, Saito K, et al. Japan College of Rheumatology 2009 guidelines for the use of tocilizumab, a humanized anti-interleukin-6 receptor monoclonal antibody, in rheumatoid arthritis. Mod Rheumatol. 2009;19:351–7.
12. Prevoo ML, van ‘t Hof MA, Kuper HH, van Leeuwen MA, van de Putte LB, van Riel PL., Modified disease activity scores that include twenty-eight-joint counts. Development and validation in a prospective longitudinal study of patients with rheumatoid arthritis. Arthritis Rheum. 1995;38:44–8.
13. Fransen J, Creemers MC, Van Riel PL., Remission in rheumatoid arthritis:agreement of the disease activity score (DAS28) with the ARA preliminary remission criteria. Rheumatology (Oxford). 2004;43:1252–5.
14. Smolen JS, Breedveld FC, Schiff MH, Kalden JR, Emery P, Eberl G, et al. A simplified disease activity index for rheumatoid arthritis for use in clinical practice. Rheumatology (Oxford). 2003;42:244–57.
15. Felson DT, Smolen JS, Wells G, Zhang B, van Tuyl LH, Funovits J, et al. American College of Rheumatology/European League Against Rheumatism provisional definition of remission in rheumatoid arthritis for clinical trials. Ann Rheum Dis. 2011;70:404–13.
16. Ramey DR, Raynauld JP, Fries JF., The health assessment questionnaire 1992:status and review. Arthritis Care Res. 1992;5:119–29.
17. Nagasawa H, Kameda H, Sekiguchi N, Amano K, Takeuchi T., Normalisation of physical function by infliximab in patients with RA:factors associated with normal physical function. Clin Exp Rheumatol. 2010;28:365–72.
18. Smolen JS, Aletaha D., Interleukin-6 receptor inhibition with tocilizumab and attainment of disease remission in rheumatoid arthritis:the role of acute-phase reactants. Arthritis Rheum. 2011;63:43–52.
19. Takeuchi T, Tanaka Y, Amano K, Hoshi D, Nawata M, Nagasawa H, et al. Clinical, radiographic and functional effectiveness of tocilizumab for rheumatoid arthritis patients–REACTION 52-week study. Rheumatology (Oxford). 2011;50:1908–15.
20. Klaasen R, Cantaert T, Wijbrandts CA, Teitsma C, Gerlag DM, Out TA, et al. The value of rheumatoid factor and anti-citrullinated protein antibodies as predictors of response to infliximab in rheumatoid arthritis:an exploratory study. Rheumatology (Oxford). 2011;50:1487–93.
21. Lequerré T, Jouen F, Brazier M, Clayssens S, Klemmer N, Menard JF, et al. Autoantibodies, metalloproteinases and bone markers in rheumatoid arthritis patients are unable to predict their responses to infliximab. Rheumatology (Oxford). 2007;46:446–53.
22. Bobbio-Pallavicini F, Caporali R, Alpini C, Avalle S, Epis OM, Klersy C, et al. High IgA rheumatoid factor levels are associated with poor clinical response to tumour necrosis factor alpha inhibitors in rheumatoid arthritis. Ann Rheum Dis. 2007;66:302–7.
23. Potter C, Hyrich KL, Tracey A, Lunt M, Plant D, Symmons DP, et al. Association of rheumatoid factor and anti-cyclic citrullinated peptide positivity, but not carriage of shared epitope or PTPN22 susceptibility variants, with anti-tumour necrosis factor response in rheumatoid arthritis. Ann Rheum Dis. 2009;68:69–74.
24. Alessandri C, Bombardieri M, Papa N, Cinquini M, Magrini L, Tincani A, et al. Decrease of anti-cyclic citrullinated peptide antibodies and rheumatoid factor following anti-TNFα therapy (infliximab) in rheumatoid arthritis is associated with clinical improvement. Ann Rheum Dis. 2004;63:1218–21.
25. Bos WH, Bartelds GM, Wolbink GJ, de Koning MH, van de Stadt RJ, van Schaardenburg D, et al. Differential response of the rheumatoid factor and anticitrullinated protein antibodies during adalimumab treatment in patients with rheumatoid arthritis. J Rheumatol. 2008;35:1972–7.
26. Mikuls TR, O’Dell JR, Stoner JA, Parrish LA, Arend WP, Norris JM, et al. Association of rheumatoid arthritis treatment response and disease duration with declines in serum levels of IgM rheumatoid factor and anti-cyclic citrullinated peptide antibody. Arthritis Rheum. 2004;50:3776–82.
27. Gottenberg JE, Ravaud P, Cantagrel A, Combe B, Flipo RM, Schaeverbeke T, et al. Positivity for anti-cyclic citrullinated peptide is associated with a better response to abatacept:data from the ‘Orencia and Rheumatoid Arthritis’ registry. Ann Rheum Dis. 2012;71:1815–9.
28. Koike T, Harigai M, Inokuma S, Inoue K, Ishiguro N, Ryu J, et al. Postmarketing surveillance of the safety and effectiveness of etanercept in Japan. J Rheumatol. 2009;36:898–906.
29. Yamanaka H, Harigai M, Ishiguro N, Inokuma S, Takei S, Takeuchi T, et al. Trend of patient characteristics and its impact on the response to adalimumab in patients with rheumatoid arthritis:post hoc time-course analysis of an all-case PMS in Japan. Mod Rheumatol. 2015;25:495–502.
30. Kristensen LE, Kapetanovic MC, Gülfe A, Söderlin M, Saxne T, Geborek P., Predictors of response to anti-TNF therapy according to ACR and EULAR criteria in patients with established RA:results from the South Swedish Arthritis Treatment Group Register. Rheumatology (Oxford). 2008;47:495–9.
31. Hyrich KL, Watson KD, Silman AJ, Symmons DP, British Society for Rheumatology Biologics Register. Predictors of response to anti-TNF-alpha therapy among patients with rheumatoid arthritis:results from the British Society for Rheumatology Biologics Register. Rheumatology (Oxford). 2006;45:1558–65.
32. Dougados M, Kissel K, Conaghan PG, Mola EM, Schett G, Gerli R, et al. Clinical, radiographic and immunogenic effects after 1 year of tocilizumab-based treatment strategies in rheumatoid arthritis:the ACT-RAY study. Ann Rheum Dis. 2014;73:803–9.
33. Buckley F, Finckh A, Huizinga TW, Dejonckheere F, Jansen JP., Comparative efficacy of novel DMARDs as monotherapy and in combination with methotrexate in rheumatoid arthritis patients with inadequate response to conventional DMARDs:a network meta-analysis. J Manag Care Spec Pharm. 2015;21:409–23.
34. Koike T, Harigai M, Ishiguro N, Inokuma S, Takei S, Takeuchi T, et al. Safety and effectiveness of adalimumab in Japanese rheumatoid arthritis patients:postmarketing surveillance report of 7740 patients. Mod Rheumatol. 2014;24:390–8.
35. Solomon DH, Kremer JM, Fisher M, Curtis JR, Furer V, Harrold LR, et al. Comparative cancer risk associated with methotrexate, other non-biologic and biologic disease-modifying anti-rheumatic drugs. Semin Arthritis Rheum. 2014;43:489–97.
36. Kremer JM, Weinblatt ME, Bankhurst AD, Bulpitt KJ, Fleischmann RM, Jackson CG, et al. Etanercept added to background methotrexate therapy in patients with rheumatoid arthritis:continued observations. Arthritis Rheum. 2003;48:1493–9.
37. Fleischmann RM, Cohen SB, Moreland LW, Schiff M, Mease PJ, Smith DB, et al. Methotrexate dosage reduction in patients with rheumatoid arthritis beginning therapy with infliximab:the Infliximab Rheumatoid Arthritis Methotrexate Tapering (iRAMT) trial. Curr Med Res Opin. 2005;21:1181–90.
38. Weinblatt ME, Keystone EC, Furst DE, Kavanaugh AF, Chartash EK, Segurado OG., Long term efficacy and safety of adalimumab plus methotrexate in patients with rheumatoid arthritis:ARMADA 4 year extended study. Ann Rheum Dis. 2006;65:753–9.
39. Saag KG, Koehnke R, Caldwell JR, Brasington R, Burmeister LF, Zimmerman B, et al. Low dose long-term corticosteroid therapy in rheumatoid arthritis:an analysis of serious adverse events. Am J Med. 1994;96:115–23.
40. Hoes JN, Jacobs JW, Verstappen SM, Bijlsma JW, Van der Heijden GJ., Adverse events of low- to medium-dose oral glucocorticoids in inflammatory diseases:a meta-analysis. Ann Rheum Dis. 2009;68:1833–8.
41. Gaujoux-Viala C, Nam J, Ramiro S, Landewé R, Buch MH, Smolen JS, et al. Efficacy of conventional synthetic disease-modifying antirheumatic drugs, glucocorticoids and tofacitinib:a systematic literature review informing the 2013 update of the EULAR recommendations for management of rheumatoid arthritis. Ann Rheum Dis. 2014;73:510–5.
42. Nishimoto N, Ito K, Takagi N., Safety and efficacy profiles of tocilizumab monotherapy in Japanese patients with rheumatoid arthritis:meta-analysis of six initial trials and five long-term extensions. Mod Rheumatol. 2010;20:222–32.