Skip to main content
Top

22-02-2018 | Rheumatoid arthritis | Article

Real-World Treatment Patterns for Golimumab and Concomitant Medications in Japanese Rheumatoid Arthritis Patients

Journal: Rheumatology and Therapy

Authors: Masateru Okazaki, Hisanori Kobayashi, Yutaka Ishii, Masayoshi Kanbori, Tsutomu Yajima

Publisher: Springer Healthcare

Abstract

Introduction

The aim of this study was to investigate real-world treatment patterns for use of golimumab and concomitant medications in Japanese patients with rheumatoid arthritis.

Methods

This study was a post hoc retrospective analysis from post-marketing surveillance data on 2350 Japanese patients with moderate/severe rheumatoid arthritis who received golimumab for 24 weeks. The study population was divided based on initiation treatment or dose adjustment patterns with golimumab, methotrexate, or oral glucocorticoids.

Results

Logistic regression analysis revealed that the baseline factors associated with administration of golimumab (100 mg) were higher body weight, failure of prior biological therapy (bio-failure), no previous methotrexate use, and respiratory disease, while previous methotrexate use and absence of renal impairment or respiratory disease were associated with concomitant methotrexate therapy, and previous glucocorticoid use was associated with concomitant glucocorticoid therapy. The following associations were identified with regard to dose adjustment during treatment: bio-failure, no previous methotrexate use, previous csDMARDs use, presence of respiratory disease, allergy history, and higher CRP for golimumab dose escalation; shorter disease duration, previous GC, and no previous methotrexate use for methotrexate dose escalation; no prior biological therapy and renal impairment for methotrexate dose reduction; no previous GC use for glucocorticoid dose escalation; and absence of Steinbrocker’s stage II/III/IV, absence of Steinbrocker’s class II, no bio-failure, and no previous csDMARDs use for glucocorticoid dose reduction.

Conclusions

This study revealed that various baseline factors were associated with initiation of treatment and dose adjustment of golimumab, methotrexate, or oral glucocorticoids, reflecting both the treatment strategies of physicians for improving RA symptoms and/or reducing adverse events.

Funding

Janssen Pharmaceutical K.K. and Mitsubishi Tanabe Pharma Corporation.
Literature
1.
Yamanaka H, Sugiyama N, Inoue E, Taniguchi A, Momohara S. Estimates of the prevalence of and current treatment practices for rheumatoid arthritis in Japan using reimbursement data from health insurance societies and the IORRA cohort (I). Mod Rheumatol. 2014;24(1):33–40.CrossRefPubMed
2.
McInnes IB, Schett G. The pathogenesis of rheumatoid arthritis. N Engl J Med. 2011;365(23):2205–19.CrossRefPubMed
3.
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(9):2569–81.CrossRefPubMed
4.
Rossini M, De Vita S, Ferri C, Govoni M, Paolazzi G, Salvarani C, et al. Golimumab: a novel anti-tumor necrosis factor. Biol Ther. 2013;3(2):83–107.CrossRefPubMedCentral
5.
Zidi I, Bouaziz A, Mnif W, Bartegi A, Al-Hizab FA, Amor NB. Golimumab therapy of rheumatoid arthritis: an overview. Scand J Immunol. 2010;72(2):75–85.CrossRefPubMed
6.
Keystone EC, Genovese MC, Klareskog L, Hsia EC, Hall ST, Miranda PC, et al. Golimumab, a human antibody to tumour necrosis factor alpha given by monthly subcutaneous injections, in active rheumatoid arthritis despite methotrexate therapy: the GO-FORWARD Study. Ann Rheum Dis. 2009;68(6):789–96.CrossRefPubMed
7.
Kavanaugh A, McInnes I, Mease P, Krueger GG, Gladman D, Gomez-Reino J, et al. Golimumab, a new human tumor necrosis factor alpha antibody, administered every four weeks as a subcutaneous injection in psoriatic arthritis: twenty-four-week efficacy and safety results of a randomized, placebo-controlled study. Arthritis Rheum. 2009;60(4):976–86.CrossRefPubMed
8.
Inman RD, Davis JC Jr, Heijde D, Diekman L, Sieper J, Kim SI, et al. Efficacy and safety of golimumab in patients with ankylosing spondylitis: results of a randomized, double-blind, placebo-controlled, phase III trial. Arthritis Rheum. 2008;58(11):3402–12.CrossRefPubMed
9.
Sieper J, van der Heijde D, Dougados M, Maksymowych WP, Scott BB, Boice JA, et al. A randomized, double-blind, placebo-controlled, sixteen-week study of subcutaneous golimumab in patients with active nonradiographic axial spondyloarthritis. Arthritis Rheumatol. 2015;67(10):2702–12.CrossRefPubMedPubMedCentral
10.
Tanaka Y, Harigai M, Takeuchi T, Yamanaka H, Ishiguro N, Yamamoto K, et al. Golimumab in combination with methotrexate in Japanese patients with active rheumatoid arthritis: results of the GO-FORTH study. Ann Rheum Dis. 2012;71(6):817–24.CrossRefPubMed
11.
Takeuchi T, Harigai M, Tanaka Y, Yamanaka H, Ishiguro N, Yamamoto K, et al. Golimumab monotherapy in Japanese patients with active rheumatoid arthritis despite prior treatment with disease-modifying antirheumatic drugs: results of the phase 2/3, multicentre, randomised, double-blind, placebo-controlled GO-MONO study through 24 weeks. Ann Rheum Dis. 2013;72(9):1488–95.CrossRefPubMed
12.
Kanbori M, Suzuka H, Yajima T, Kishino E, Morishige R, Momohara S, et al. Postmarketing surveillance evaluating the safety and effectiveness of golimumab in Japanese patients with rheumatoid arthritis. Mod Rheumatol. 2018;28(1):66–75.CrossRefPubMed
13.
Smolen JS, Landewe R, Bijlsma J, Burmester G, Chatzidionysiou K, Dougados M, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 update. Ann Rheum Dis. 2017;76(6):960–77.CrossRefPubMed
14.
Smolen JS, Kay J, Doyle MK, Landewe R, Matteson EL, Wollenhaupt J, et al. Golimumab in patients with active rheumatoid arthritis after treatment with tumour necrosis factor alpha inhibitors (GO-AFTER study): a multicentre, randomised, double-blind, placebo-controlled, phase III trial. Lancet. 2009;374(9685):210–21.CrossRefPubMed
15.
van der Heijde D, Klareskog L, Rodriguez-Valverde V, Codreanu C, Bolosiu H, Melo-Gomes J, et al. Comparison of etanercept and methotrexate, alone and combined, in the treatment of rheumatoid arthritis: two-year clinical and radiographic results from the TEMPO study, a double-blind, randomized trial. Arthritis Rheum. 2006;54(4):1063–74.CrossRefPubMed
16.
Breedveld FC, Weisman MH, Kavanaugh AF, Cohen SB, Pavelka K, van Vollenhoven R, et al. The PREMIER study: a multicenter, randomized, double-blind clinical trial of combination therapy with adalimumab plus methotrexate versus methotrexate alone or adalimumab alone in patients with early, aggressive rheumatoid arthritis who had not had previous methotrexate treatment. Arthritis Rheum. 2006;54(1):26–37.CrossRefPubMed
17.
Klareskog L, van der Heijde D, de Jager JP, Gough A, Kalden J, Malaise M, et al. Therapeutic effect of the combination of etanercept and methotrexate compared with each treatment alone in patients with rheumatoid arthritis: double-blind randomised controlled trial. Lancet. 2004;363(9410):675–81.CrossRefPubMed
18.
Furst DE, Kremer JM. Methotrexate in rheumatoid arthritis. Arthritis Rheum. 1988;31(3):305–14.CrossRefPubMed
19.
Prevoo MLL, Van’T Hof MA, Kuper HH, Van Leeuwen MA, Van De Putte LBA, Van Riel PLCM. 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(1):44–8.CrossRefPubMed
20.
Steinbrocker O, Traeger CH, Batterman RC. Therapeutic criteria in rheumatoid arthritis. J Am Med Assoc. 1949;140(8):659–62.CrossRefPubMed
21.
A language and environment for statistical computing R Foundation for Statistical Computing, Vienna: R Core Team; 2016. https://​www.​R-project.​org/​.
22.
Zhou H, Jang H, Fleischmann RM, Bouman-Thio E, Xu Z, Marini JC, et al. Pharmacokinetics and safety of golimumab, a fully human anti-TNF-alpha monoclonal antibody, in subjects with rheumatoid arthritis. J Clin Pharmacol. 2007;47(3):383–96.CrossRefPubMed
23.
Xu Z, Vu T, Lee H, Hu C, Ling J, Yan H, et al. Population pharmacokinetics of golimumab, an anti-tumor necrosis factor-alpha human monoclonal antibody, in patients with psoriatic arthritis. J Clin Pharmacol. 2009;49(9):1056–70.CrossRefPubMed
24.
Becciolini A, Biggioggero M, Favalli EG. The role of methotrexate as combination therapy with etanercept in rheumatoid arthritis: retrospective analysis of a local registry. J Int Med Res. 2016;44(1 suppl):113–8.CrossRefPubMedPubMedCentral
25.
Kashiwazaki S, Ichikawa Y, Sugawara S, Nagaya I, Kawai S, Hakota M, et al. Determination of the clinical optimal dose of L-377 (methotrexate capsule) for the treatment of rheumatoid arthritis. Ensho. 1996;16(6):437–58.CrossRef
26.
Japan College of Rheumatology 2016 guidelines for the use of methotrexate (MTX) in rheumatoid arthritis Japan College of Rheumatology Subcommittee on Development of Guidelines for the Use of Methotrexate in the Treatment of Rheumatoid Arthritis: Yodosha; 2016. http://​www.​ryumachi-jp.​com/​publication/​pdf/​MTX2016kanni.​pdf.
27.
Frei E 3rd, Blum RH, Pitman SW, Kirkwood JM, Henderson IC, Skarin AT, et al. High dose methotrexate with leucovorin rescue. Rationale and spectrum of antitumor activity. Am J Med. 1980;68(3):370–6.CrossRefPubMed
28.
Alarcon GS, Kremer JM, Macaluso M, Weinblatt ME, Cannon GW, Palmer WR, et al. Risk factors for methotrexate-induced lung injury in patients with rheumatoid arthritis. A multicenter, case-control study. Methotrexate-Lung Study Group. Ann Intern Med. 1997;127(5):356–64.CrossRefPubMed
29.
Combe B, Landewe R, Daien CI, Hua C, Aletaha D, Alvaro-Gracia JM, et al. 2016 update of the EULAR recommendations for the management of early arthritis. Ann Rheum Dis. 2017;76(6):948–59.CrossRefPubMed
30.
Braun J. Methotrexate: optimizing the efficacy in rheumatoid arthritis. Ther Adv Musculoskelet Dis. 2011;3(3):151–8.CrossRefPubMedPubMedCentral
31.
Attar SM. Adverse effects of low dose methotrexate in rheumatoid arthritis patients. A hospital-based study. Saudi Med J. 2010;31(8):909–15.PubMed
32.
Manders SH, van de Laar MA, Rongen-van Dartel SA, Bos R, Visser H, Brus HL, et al. Tapering and discontinuation of methotrexate in patients with RA treated with TNF inhibitors: data from the DREAM registry. RMD Open. 2015;1(1):e000147.CrossRefPubMedPubMedCentral
33.
Emery P, Hammoudeh M, FitzGerald O, Combe B, Martin-Mola E, Buch MH, et al. Sustained remission with etanercept tapering in early rheumatoid arthritis. N Engl J Med. 2014;371(19):1781–92.CrossRefPubMed
34.
Makol A, Davis JM, Crowson CS, Therneau TM, Gabriel SE, Matteson EL. Time trends in glucocorticoid use in rheumatoid arthritis: results from a population-based inception cohort, 1980-1994 versus 1995–2007. Arthritis Care Res. 2014;66(10):1482–8.CrossRef
35.
Venables WN, Ripley BD. Modern applied statistics with S. In: Poisson and Multinomial Models. New York: Springer; 2002. pp. 199–205.