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Rheumatoid arthritis treated with 6-months of first-line biologic or biosimilar therapy: an updated systematic review and network meta-analysis

Published online by Cambridge University Press:  06 February 2019

Emma L. Simpson ,
Shijie Ren ,
Emma S. Hock Open the ORCID record for Emma S. Hock [Opens in a new window] ,
John W. Stevens ,
Aymeric Binard ,
Yves-Marie Pers ,
Rachel Archer ,
Suzy Paisley ,
Matthew D. Stevenson  and
Chloé Herpin
...Show all authors
Emma L. Simpson
Affiliation:
School of Health and Related Research (ScHARR), University of Sheffield, United Kingdom
Shijie Ren
Affiliation:
School of Health and Related Research (ScHARR), University of Sheffield, United Kingdom
Emma S. Hock
Affiliation:
School of Health and Related Research (ScHARR), University of Sheffield, United Kingdom
John W. Stevens
Affiliation:
School of Health and Related Research (ScHARR), University of Sheffield, United Kingdom
Aymeric Binard
Affiliation:
Department of Rheumatology, CHU de la Cavale-Blanche, Brest, France
Yves-Marie Pers
Affiliation:
Clinical Immunology and Osteoarticular Diseases Therapeutic Unit, Lapeyronie University Hospital, Montpellier, France IRMB, University of Montpellier, INSERM, CHU Montpellier, Montpellier, France
Rachel Archer
Affiliation:
School of Health and Related Research (ScHARR), University of Sheffield, United Kingdom
Suzy Paisley
Affiliation:
School of Health and Related Research (ScHARR), University of Sheffield, United Kingdom
Matthew D. Stevenson
Affiliation:
School of Health and Related Research (ScHARR), University of Sheffield, United Kingdom
Chloé Herpin
Affiliation:
Department of Economic and Public Health Evaluation, French National Authority for Health (HAS), Saint-Denis La Plaine, France
Salah Ghabri*
Affiliation:
Department of Economic and Public Health Evaluation, French National Authority for Health (HAS), Saint-Denis La Plaine, France
*
Author for correspondence: Salah Ghabri, E-mail: s.ghabri@has-sante.fr
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Abstract

Objectives

The aim of this study was to estimate the effectiveness of first-line biologic disease modifying drugs(boDMARDs), and their approved biosimilars (bsDMARDs), compared with conventional (csDMARD) treatment, in terms of ACR (American College of Rheumatology) and EULAR (European League against Rheumatism) responses.

Methods

Systematic literature search, on eight databases to January 2017, sought ACR and EULAR data from randomized controlled trials (RCTs) of boDMARDs / bsDMARDs (in combination with csDMARDs, or monotherapy). Two adult populations: methotrexate (MTX)-naïve patients with severe active RA; and csDMARD-experienced patients with moderate-to-severe active RA. Network meta-analyses (NMA) were conducted using a Bayesian Markov chain Monte Carlo simulation using a random effects model with a probit link function for ordered categorical.

Results

Forty-six RCTs met the eligibility criteria. In the MTX-naïve severe active RA population, no biosimilar trials meeting the inclusion criteria were identified. MTX plus methylprednisolone (MP) was most likely to achieve the best ACR response. There was insufficient evidence that combination boDMARDs was superior to intensive (two or more) csDMARDs. In the csDMARD-experienced, moderate-to-severe RA population, the greatest effects for ACR responses were associated with tocilizumab (TCZ) monotherapy, and combination therapy (plus MTX) with bsDMARD etanercept (ETN) SB4, boDMARD ETN and TCZ. These treatments also had the greatest effects on EULAR responses. No clear differences were found between the boDMARDs and their bsDMARDs.

Conclusions

In MTX-naïve patients, there was insufficient evidence that combination boDMARDs was superior to two or more csDMARDs. In csDMARD-experienced patients, boDMARDs and bsDMARDs were comparable and all combination boDMARDs / bsDMARDs were superior to single csDMARD.

Keywords

Rheumatoid arthritisBiological agentsBiosimilarSystematic reviewNetwork meta-analysis
Type
Assessment
Information
International Journal of Technology Assessment in Health Care , Volume 35 , Issue 1 , 2019 , pp. 36 - 44
Copyright
Copyright © Cambridge University Press 2019 

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References

1.Moher, D, Liberati, A, Tetzlaff, J, Altman, DG and The, PG (2009) Preferred reporting items for systematic reviews and meta-analyses: The PRISMA statement. PLoS Med 6, e1000097.Google Scholar
2.Stevenson, M, Archer, R, Tosh, J, et al. (2016) Adalimumab, etanercept, infliximab, certolizumab pegol, golimumab, tocilizumab and abatacept for the treatment of rheumatoid arthritis not previously treated with disease-modifying antirheumatic drugs and after the failure of conventional disease-modifying antirheumatic drugs only: Systematic review and economic evaluation. Health Technol Assess 20, 1–610.Google Scholar
3.The_Cochrane_Collaboration (2011) Cochrane handbook for systematic reviews of interventions. handbook.cochrane.org (accessed December 5, 2018).Google Scholar
4.Dias, S, Sutton, AJ, Ades, AE and Welton, NJ (2013) Evidence synthesis for decision making 2: A generalized linear modeling framework for pairwise and network meta-analysis of randomized controlled trials. Med Decis Making 33, 607–617.Google Scholar
5.Sturtz, S, Ligges, U and Gelman, A (2005) R2WinBUGS: A package for running WinBUGS from R. J Stat Softw 12, 1–16.Google Scholar
6.Brooks, S and Gelman, A (1998) General methods for monitoring convergence of iterative simulations. J Comput Graph Stat 7, 434–455.Google Scholar
7.van den Broek, M, Dirven, L, Klarenbeek, N, et al. (2013) Clinical and radiological outcomes of four disease activity driven treatment strategies: 8-year results of the best study. Annals of the Rheumatic Disease [Internet], https://ard.bmj.com/content/71/Suppl_3/106.1 (accessed December 5, 2018).Google Scholar
8.Emery, P, Breedveld, FC, Hall, S, et al. (2008) 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 372, 375–382.Google Scholar
9.Durez, P, Malghem, J, Toukap, AN, et al. (2007) Treatment of early rheumatoid arthritis: A randomized magnetic resonance imaging study comparing the effects of methotrexate alone, methotrexate in combination with infliximab, and methotrexate in combination with intravenous pulse methylprednisolone. Arthritis Rheum 56, 3919–3927.Google Scholar
10.Bathon, JM, Martin, RW, Fleischmann, RM, et al. (2000) A comparison of etanercept and methotrexate in patients with early rheumatoid arthritis. N Engl J Med 343, 1586–1593.Google Scholar
11.Emery, P, Fleischmann, RM, Moreland, LW, et al. (2009) Golimumab, a human anti-tumor necrosis factor alpha monoclonal antibody, injected subcutaneously every four weeks in methotrexate-naive patients with active rheumatoid arthritis: Twenty-four-week results of a phase III, multicenter, randomized, double-blind, placebo-controlled study of golimumab before methotrexate as first-line therapy for early-onset rheumatoid arthritis. Arthritis Rheum 60, 2272–2283.Google Scholar
12.Detert, J, Bastian, H, Listing, J, et al. (2013) Induction therapy with adalimumab plus methotrexate for 24 weeks followed by methotrexate monotherapy up to week 48 versus methotrexate therapy alone for DMARD-naive patients with early rheumatoid arthritis: HIT HARD, an investigator-initiated study. Ann Rheum Dis 72, 844–850.Google Scholar
13.Takeuchi, T, Yamanaka, H, Ishiguro, N, et al. (2014) Adalimumab, a human anti-TNF monoclonal antibody, outcome study for the prevention of joint damage in Japanese patients with early rheumatoid arthritis: The HOPEFUL 1 study. Ann Rheum Dis 73, 536–543.Google Scholar
14.Nam, JL, Villeneuve, E, Hensor, EM, et al. (2014) Remission induction comparing infliximab and high-dose intravenous steroid, followed by treat-to-target: A double-blind, randomised, controlled trial in new-onset, treatment-naive, rheumatoid arthritis (the IDEA study). Annals of the rheumatic diseases [Internet] 73, 75–85. http://ard.bmj.com/content/73/1/75.full.pdf (accessed December 5, 2018).Google Scholar
15.Kavanaugh, A, Fleischmann, RM, Emery, P, et al. (2013) Clinical, functional and radiographic consequences of achieving stable low disease activity and remission with adalimumab plus methotrexate or methotrexate alone in early rheumatoid arthritis: 26-week results from the randomised, controlled OPTIMA study. Ann Rheum Dis 72, 64–71.Google Scholar
16.Breedveld, FC, Weisman, MH, Kavanaugh, AF, et al. (2006) 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 54, 26–37.Google Scholar
17.Dougados, M, Kissel, K, Sheeran, T, et al. (2013) Adding tocilizumab or switching to tocilizumab monotherapy in methotrexate inadequate responders: 24-week symptomatic and structural results of a 2 year randomized controlled strategy trial in rheumatoid arthritis (ACT-RAY). Ann Rheum Dis 72, 43–50.Google Scholar
18.Gabay, C, Emery, P, van, VR, et al. (2013) Tocilizumab monotherapy versus adalimumab monotherapy for treatment of rheumatoid arthritis (ADACTA): A randomised, double-blind, controlled phase 4 trial. Lancet 381, 1541–1550.Google Scholar
19.Russell, AS, Wallenstein, GV, Li, T, et al. (2007) Abatacept improves both the physical and mental health of patients with rheumatoid arthritis who have inadequate response to methotrexate treatment. Ann Rheum Dis 66, 189–194.Google Scholar
20.Fleischmann, R, Schiff, MH, Weinblatt, ME, et al. (2012) Effects of subcutaneous abatacept or adalimumab on remission and associated changes in physical function and radiographic outcomes: One year results from the ample (abatacept versus adalimumab comparison in biologic-naive ra subjects with background methotrexate) trial. Arthritis Rheum 64, S577.Google Scholar
21.Weinblatt, ME, Keystone, EC, Furst, DE, et al. (2003) Adalimumab, a fully human anti-tumor necrosis factor alpha monoclonal antibody, for the treatment of rheumatoid arthritis in patients taking concomitant methotrexate: The ARMADA trial. Arthritis Rheum 48, 35–45.Google Scholar
22.Schiff, M, Keiserman, M, Codding, C, et al. (2008) Efficacy and safety of abatacept or infliximab vs placebo in ATTEST: A phase III, multi-centre, randomised, double-blind, placebo-controlled study in patients with rheumatoid arthritis and an inadequate response to methotrexate. Ann Rheum Dis 67, 1096–1103.Google Scholar
23.Maini, R, St Clair, EW, Breedveld, F, et al. (1999) Infliximab (chimeric anti-tumour necrosis factor alpha monoclonal antibody) versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate: A randomised phase III trial. Lancet 354, 1932–1939.Google Scholar
24.van Vollenhoven, RF, Kinnman, N, Vincent, E, Wax, S, Bathon, J (2011) Atacicept in patients with rheumatoid arthritis and an inadequate response to methotrexate: Results of a phase II, randomized, placebo-controlled trial. Arthritis Rheum 63, 1782–1792.Google Scholar
25.Smolen, J, Emery, P, Ferraccioli, G (2011) Efficacy and safety of certolizumab pegol after incomplete response to DMARDS in RA patients with low moderate disease activity: Results from certain, a phase IIIb study. Ann Rheum Dis 70, 259.Google Scholar
26.Miyasaka, N (2008) Clinical investigation in highly disease-affected rheumatoid arthritis patients in Japan with adalimumab applying standard and general evaluation: The CHANGE study. Mod Rheumatol 18, 252–262.Google Scholar
27.Keystone, EC, Kavanaugh, AF, Sharp, JT, et al. (2004) Radiographic, clinical, and functional outcomes of treatment with Adalimumab (a human anti-tumor necrosis factor monoclonal antibody) in patients with active rheumatoid arthritis receiving concomitant methotrexate therapy: A randomized, placebo-controlled, 52-week trial. Arthritis Rheum 50, 1400–1411.Google Scholar
28.De Filipis, L, Caliri, A, Anghelone, S, et al. (2006) Improving outcomes in tumour necrosis factor alpha treatment: Comparison of the efficacy of the tumour necrosis factor alpha blocking agents etanercept and infliximab in patients with active rheumatoid arthritis. Panminerva Med 48, 129–135.Google Scholar
29.Combe, B, Codreanu, C, Fiocco, U, et al. (2006) Etanercept and sulfasalazine, alone and combined, in patients with active rheumatoid arthritis despite receiving sulfasalazine: A double-blind comparison. Ann Rheum Dis 65, 1357–1362.Google Scholar
30.Tanaka, Y, Harigai, M, Takeuchi, T, et al. (2012) Golimumab in combination with methotrexate in Japanese patients with active rheumatoid arthritis: Results of the GO-FORTH study. Ann Rheum Dis 71, 817–824.Google Scholar
31.Keystone, E, Genovese, MC, Klareskog, L, et al. (2010) Golimumab in patients with active rheumatoid arthritis despite methotrexate therapy: 52-week results of the GO-FORWARD study. Ann Rheum Dis 69, 1129–1135.Google Scholar
32.Keystone, EC, Wang, MM, Layton, M, Hollis, S, McInnes, IB, Study, T (2012) Clinical evaluation of the efficacy of the P2X7 purinergic receptor antagonist AZD9056 on the signs and symptoms of rheumatoid arthritis in patients with active disease despite treatment with methotrexate or sulphasalazine. [Erratum appears in Ann Rheum Dis. 2012;71:2064]. Ann Rheum Dis 71, 1630–1625.Google Scholar
33.Kameda, H, Ueki, Y, Saito, K, et al. (2010) Etanercept (ETN) with methotrexate (MTX) is better than ETN monotherapy in patients with active rheumatoid arthritis despite MTX therapy: A randomized trial. Mod Rheumatol 20, 531–538.Google Scholar
34.Kim, HY, Lee, SK, Song, YW, et al. (2007) A randomized, double-blind, placebo-controlled, phase III study of the human anti-tumor necrosis factor antibody adalimumab administered as subcutaneous injections in Korean rheumatoid arthritis patients treated with methotrexate. J Rheumatol 10, 9–16.Google Scholar
35.Machado, D, Guzman, R, Xavier, R, et al. , editors. Combination etanercept and methotrexate therapy provides better outcomes than standard DMARD and methotrexate therapy in rheumatoid arthritis: Results from a study in the Latin America region. Presented at XVII Congress of Pan American League of Associations of Rheumatology (PANLAR); Punta Cana, Dominican Republic; 17–21 April 2012.Google Scholar
36.Moreland, LW, Schiff, MH, Baumgartner, SW, et al. (1999) Etanercept therapy in rheumatoid arthritis: A randomized, controlled trial. Ann Intern Med 130, 478–486.Google Scholar
37.Takeuchi, T, Miyasaka, N, Zang, C, et al. (2013) A phase 3 randomized, double-blind, multicenter comparative study evaluating the effect of etanercept versus methotrexate on radiographic outcomes, disease activity, and safety in Japanese subjects with active rheumatoid arthritis. Mod Rheumatol 23, 623–633.Google Scholar
38.Matsubara, T, Inoue, H, Iwahashi, M, Yamazaki, A and Takeuchi, T (2013) A multi-center, double-dummy, double-blind study of subcutaneous (SC) abatacept (ABA) compared with intraveneous (IV) ABA in japanese rheumatoid arthritis patients with inadequate response to methotrexate. Annals of the Rheumatic Disease [Internet], 71. http://ard.bmj.com/content/71/Suppl_3/197.1.full.pdf (accessed December 5, 2018).Google Scholar
39.Emery, P, Vencovsky, J, Sylwestrzak, A, et al. (2017) A phase III randomised, double-blind, parallel-group study comparing SB4 with etanercept reference product in patients with active rheumatoid arthritis despite methotrexate therapy. Ann Rheum Dis 76, 51–57.Google Scholar
40.Choe, J-Y, Prodanovic, N, Niebrzydowski, J, et al. (2017) A randomised, double-blind, phase III study comparing SB2, an infliximab biosimilar, to the infliximab reference product Remicade in patients with moderate to severe rheumatoid arthritis despite methotrexate therapy. Ann Rheum Dis 76, 58–64.Google Scholar
41.Yoo, DH, Hrycaj, P, Miranda, P, et al. (2013) A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: The PLANETRA study. Ann Rheum Dis 72, 1613–1620.Google Scholar
42.O'Dell, JR, Mikuls, TR, Taylor, TH, Ahluwalia, V, Brophy, M, Warren, SR, et al. (2013) Therapies for active rheumatoid arthritis after methotrexate failure. The New England journal of medicine [Internet], 369:[307–18 pp.]. http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/394/CN-00876394/frame.html.Google Scholar
43.Nishimoto, N, Hashimoto, J, Miyasaka, N, et al. (2007) 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 66, 1162–1167.Google Scholar
44.Nishimoto, N, Miyasaka, N, Yamamoto, K, et al. (2009) 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 19, 12–19.Google Scholar
45.Furst, DE, Schiff, MH, Fleischmann, RM, et al. (2003) Adalimumab, a fully human anti-tumor necrosis factor-alpha monoclonal antibody, and concomitant standard antirheumatic therapy for the treatment of rheumatoid arthritis: Results of STAR (Safety Trial of Adalimumab in Rheumatoid Arthritis). J Rheumatol 30, 2563–2571.Google Scholar
46.Westhovens, R, Yocum, D, Han, J, et al. (2006) The safety of infliximab, combined with background treatments, among patients with rheumatoid arthritis and various comorbidities: A large, randomized, placebo-controlled trial. Arthritis Rheum 54, 1075–1086.Google Scholar
47.Kaneko, Y, Atsumi, T, Tanaka, Y, et al. (2016) Comparison of adding tocilizumab to methotrexate with switching to tocilizumab in patients with rheumatoid arthritis with inadequate response to methotrexate: 52-week results from a prospective, randomised, controlled study (SURPRISE study). Ann Rheum Dis 75, 1917–1923.Google Scholar
48.van Vollenhoven, RF, Ernestam, S, Geborek, P, et al. (2009) Addition of infliximab compared with addition of sulfasalazine and hydroxychloroquine to methotrexate in patients with early rheumatoid arthritis (Swefot trial): 1-year results of a randomised trial. Lancet 374, 459–466.Google Scholar
49.Scott, DL, Ibrahim, F, Farewell, V, et al. Tumour necrosis factor inhibitors versus combination intensive therapy with conventional disease modifying anti-rheumatic drugs in established rheumatoid arthritis: TACIT non-inferiority randomised controlled trial. BMJ (Online) [Internet]. 2015; 350. https://www.bmj.com/content/350/bmj.h1046 (accessed December 5, 2018).Google Scholar
50.Genovese, MC, McKay, JD, Nasonov, EL, et al. (2008) 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 58, 2968–2980.Google Scholar
51.Van De Putte, LBA, Atkins, C, Malaise, M, et al. (2004) Efficacy and safety of adalimumab as monotherapy in patients with rheumatoid arthritis for whom previous disease modifying antirheumatic drug treatment has failed. Ann Rheum Dis 63, 508–516.Google Scholar
52.Weinblatt, ME, Kremer, JM, Bankhurst, AD, et al. (1999) A trial of etanercept, a recombinant tumor necrosis factor receptor:Fc fusion protein, in patients with rheumatoid arthritis receiving methotrexate. N Engl J Med 340, 253–259.Google Scholar
53.CADTH Health Technology Assessment (2018) Drugs for the management of rheumatoid arthritis clinical evaluation. Ottawa: CADTHGoogle Scholar
54.ICER. Evidence report (2017) Targeted immune modulators for rheumatoid arthritis: Effectiveness & value. New England: ICERGoogle Scholar
55.Singh, JA, Hossain, A, Tanjong Ghogomu, E, et al. (2016) Biologics or tofacitinib for rheumatoid arthritis in incomplete responders to methotrexate or other traditional disease-modifying anti-rheumatic drugs: A systematic review and network meta-analysis. Cochrane Database Syst Rev, CD012183.Google Scholar
56.Singh, J, Hossain, A, Mudano, A, et al. (2017) Biologics or tofacitinib for people with rheumatoid arthritis naive to methotrexate: A systematic review and network meta-analysis. Cochrane Database Syst Rev 13, CD012183.Google Scholar
57.Hazlewood, GS, Barnabe, C, Tomlinson, G, et al. (2016) Methotrexate monotherapy and methotrexate combination therapy with traditional and biologic disease modifying antirheumatic drugs for rheumatoid arthritis: Abridged Cochrane systematic review and network meta-analysis. BMJ 353, i1777.Google Scholar
58.European Medicines Agency (2015) Guideline on clinical investigation of medicinal products other than NSAIDs for treatment of rheumatoid arthritis. Contract No.: CPMP/EWP/556/95 Rev. 2. London: European Medicines Agency.Google Scholar
59.Pierreisnard, A, Issa, N, Barnetche, T, Richez, C, Schaeverbeke, T (2013) Meta-analysis of clinical and radiological efficacy of biologics in rheumatoid arthritis patients naive or inadequately responsive to methotrexate. Joint Bone Spine 80, 386–392.Google Scholar
60.Gaujoux-Viala, C, Gossec, L, Cantagrel, A, et al. (2014) Recommendations of the French Society for Rheumatology for managing rheumatoid arthritis. Joint Bone Spine 81, 287–297.Google Scholar
61.Alfonso-Cristancho, R, Armstrong, N, Arjunji, R, et al. (2016) Comparative effectiveness of biologics for the management of rheumatoid arthritis: Systematic review and network meta-analysis. Clin Rheumatol 36, 25–34.Google Scholar
62.Smolen, JS, Aletaha, D (2011) Interleukin-6 receptor inhibition with tocilizumab and attainment of disease remission in rheumatoid arthritis: The role of acute-phase reactants. Arthritis Rheum 63, 43–52.Google Scholar
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