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Erschienen in: Clinical Rheumatology 5/2018

01.02.2018 | Original Article

Comparative efficacy and safety of biosimilar adalimumab and originator adalimumab in combination with methotrexate in patients with active rheumatoid arthritis: a Bayesian network meta-analysis of randomized controlled trials

verfasst von: Sang-Cheol Bae, Young Ho Lee

Erschienen in: Clinical Rheumatology | Ausgabe 5/2018

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Abstract

We aimed to assess the relative efficacy and safety of biosimilar adalimumab and originator adalimumab plus methotrexate (MTX) compared to those of placebo plus MTX in patients with active rheumatoid arthritis (RA) who showed an inadequate response to MTX. We performed a Bayesian network meta-analysis to combine direct and indirect evidence from randomized controlled trials (RCTs) examining the efficacy and safety of biosimilar + MTX and adalimumab + MTX versus placebo + MTX (MTX group) in patients with active RA despite treatment with MTX. A total of eight RCTs involving 2543 patients met the inclusion criteria. The ACR20 response rate was significantly higher in the biosimilar + MTX (odds ratio [OR] 2.91, 95% credible interval [CrI] 1.57–5.74) and adalimumab + MTX (OR 2.80, 95% CrI 1.81–4.46) groups than in the MTX group, with no difference in the ACR20 response rate between the biosimilar + MTX and adalimumab + MTX groups. Biosimilar + MTX had the highest probability of being the best treatment in terms of the ACR20 response rate (surface under the cumulative ranking curve [SUCRA] = 0.7896), followed by adalimumab + MTX (SUCRA = 0.7082) and MTX (SUCRA = 0.0022). The ACR50 and ACR70 response rates showed a distribution pattern similar to that of the ACR20 response rate. Safety based on the number of serious adverse events did not differ significantly among the three interventions in the follow-up period of 12 to 24 weeks. Biosimilar and originator adalimumab, in combination with MTX, represent an effective intervention for active RA despite treatment with MTX. No significant difference was found between biosimilar and originator adalimumab in terms of efficacy and safety. However, follow-up in RCTs is short and not all safety outcomes can be assessed in RCTs. Thus, additional long-term evaluations are needed.
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Literatur
1.
Zurück zum Zitat Smolen JS, Aletaha D, McInnes IB (2016) Rheumatoid arthritis. The Lancet Smolen JS, Aletaha D, McInnes IB (2016) Rheumatoid arthritis. The Lancet
2.
Zurück zum Zitat Salfeld J, Kaymakcalan Z, Tracey D, Roberts A, Kamen R (1998) Generation of fully human anti-TNF antibody D2E7. Arthritis Rheum 41:S57 Salfeld J, Kaymakcalan Z, Tracey D, Roberts A, Kamen R (1998) Generation of fully human anti-TNF antibody D2E7. Arthritis Rheum 41:S57
3.
Zurück zum Zitat Weinblatt ME, Baranauskaite A, Niebrzydowski J, Dokoupilova E, Zielinska A, Jaworski J, Racewicz A, Pileckyte M, Jedrychowicz-Rosiak K, Cheong SY (2017) Phase 3 randomized study of SB5, an adalimumab biosimilar, versus reference adalimumab in patients with moderate to severe rheumatoid arthritis Arthritis Rheumatol Weinblatt ME, Baranauskaite A, Niebrzydowski J, Dokoupilova E, Zielinska A, Jaworski J, Racewicz A, Pileckyte M, Jedrychowicz-Rosiak K, Cheong SY (2017) Phase 3 randomized study of SB5, an adalimumab biosimilar, versus reference adalimumab in patients with moderate to severe rheumatoid arthritis Arthritis Rheumatol
4.
Zurück zum Zitat Jamshidi A, Gharibdoost F, Vojdanian M, Soroosh SG, Soroush M, Ahmadzadeh A, Nazarinia MA, Mousavi M, Karimzadeh H, Shakibi MR (2017) A phase III, randomized, two-armed, double-blind, parallel, active controlled, and non-inferiority clinical trial to compare efficacy and safety of biosimilar adalimumab (CinnoRA®) to the reference product (Humira®) in patients with active rheumatoid arthritis. Arthritis Res Ther 19:168CrossRefPubMedPubMedCentral Jamshidi A, Gharibdoost F, Vojdanian M, Soroosh SG, Soroush M, Ahmadzadeh A, Nazarinia MA, Mousavi M, Karimzadeh H, Shakibi MR (2017) A phase III, randomized, two-armed, double-blind, parallel, active controlled, and non-inferiority clinical trial to compare efficacy and safety of biosimilar adalimumab (CinnoRA®) to the reference product (Humira®) in patients with active rheumatoid arthritis. Arthritis Res Ther 19:168CrossRefPubMedPubMedCentral
5.
Zurück zum Zitat Cohen S, Genovese MC, Choy E, Perez-Ruiz F, Matsumoto A, Pavelka K, Pablos JL, Rizzo W, Hrycaj P, Zhang N (2017) Efficacy and safety of the biosimilar ABP 501 compared with adalimumab in patients with moderate to severe rheumatoid arthritis: a randomised, double-blind, phase III equivalence study Annals of the Rheumatic Diseases: annrheumdis-2016-210459 Cohen S, Genovese MC, Choy E, Perez-Ruiz F, Matsumoto A, Pavelka K, Pablos JL, Rizzo W, Hrycaj P, Zhang N (2017) Efficacy and safety of the biosimilar ABP 501 compared with adalimumab in patients with moderate to severe rheumatoid arthritis: a randomised, double-blind, phase III equivalence study Annals of the Rheumatic Diseases: annrheumdis-2016-210459
6.
Zurück zum Zitat Jani RH, Gupta R, Bhatia G, Rathi G, Ashok Kumar P, Sharma R, Kumar U, Gauri LA, Jadhav P, Bartakke G (2016) A prospective, randomized, double-blind, multicentre, parallel-group, active controlled study to compare efficacy and safety of biosimilar adalimumab (Exemptia; ZRC-3197) and adalimumab (Humira) in patients with rheumatoid arthritis. Int J Rheum Dis 19(11):1157–1168. https://doi.org/10.1111/1756-185X.12711 CrossRefPubMed Jani RH, Gupta R, Bhatia G, Rathi G, Ashok Kumar P, Sharma R, Kumar U, Gauri LA, Jadhav P, Bartakke G (2016) A prospective, randomized, double-blind, multicentre, parallel-group, active controlled study to compare efficacy and safety of biosimilar adalimumab (Exemptia; ZRC-3197) and adalimumab (Humira) in patients with rheumatoid arthritis. Int J Rheum Dis 19(11):1157–1168. https://​doi.​org/​10.​1111/​1756-185X.​12711 CrossRefPubMed
7.
Zurück zum Zitat Furst DE, Schiff MH, Fleischmann RM, Strand V, Birbara CA, Compagnone D, Fischkoff SA, Chartash EK (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(12):2563–2571PubMed Furst DE, Schiff MH, Fleischmann RM, Strand V, Birbara CA, Compagnone D, Fischkoff SA, Chartash EK (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(12):2563–2571PubMed
8.
Zurück zum Zitat Keystone EC, Kavanaugh AF, Sharp JT, Tannenbaum H, Hua Y, Teoh LS, Fischkoff SA, Chartash EK (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 Rheumatol 50:1400–1411CrossRef Keystone EC, Kavanaugh AF, Sharp JT, Tannenbaum H, Hua Y, Teoh LS, Fischkoff SA, Chartash EK (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 Rheumatol 50:1400–1411CrossRef
9.
Zurück zum Zitat Chen D-Y, Chou S-J, Hsieh T-Y, Chen Y-H, Chen H-H, Hsieh C-W, Lan J-L (2009) Randomized, double-blind, placebo-controlled, comparative study of human anti-TNF antibody adalimumab in combination with methotrexate and methotrexate alone in Taiwanese patients with active rheumatoid arthritis. J Formos Med Assoc 108(4):310–319. https://doi.org/10.1016/S0929-6646(09)60071-1 CrossRefPubMed Chen D-Y, Chou S-J, Hsieh T-Y, Chen Y-H, Chen H-H, Hsieh C-W, Lan J-L (2009) Randomized, double-blind, placebo-controlled, comparative study of human anti-TNF antibody adalimumab in combination with methotrexate and methotrexate alone in Taiwanese patients with active rheumatoid arthritis. J Formos Med Assoc 108(4):310–319. https://​doi.​org/​10.​1016/​S0929-6646(09)60071-1 CrossRefPubMed
10.
Zurück zum Zitat KIM HY, LEE SK, Song YW, YOO DH, KOH EM, Yoo B, Luo A (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. Int J Rheum Dis 10:9–16 KIM HY, LEE SK, Song YW, YOO DH, KOH EM, Yoo B, Luo A (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. Int J Rheum Dis 10:9–16
11.
Zurück zum Zitat Dörner T, Strand V, Castañeda-Hernández G, Ferraccioli G, Isaacs JD, Kvien TK, Martin-Mola E, Mittendorf T, Smolen JS, Burmester GR (2012) The role of biosimilars in the treatment of rheumatic diseases Annals of the Rheumatic Diseases: annrheumdis-2012-202715 Dörner T, Strand V, Castañeda-Hernández G, Ferraccioli G, Isaacs JD, Kvien TK, Martin-Mola E, Mittendorf T, Smolen JS, Burmester GR (2012) The role of biosimilars in the treatment of rheumatic diseases Annals of the Rheumatic Diseases: annrheumdis-2012-202715
12.
Zurück zum Zitat Caldwell DM, Ades A, Higgins J (2005) Simultaneous comparison of multiple treatments: combining direct and indirect evidence. BMJ: Br Med J 331:897CrossRef Caldwell DM, Ades A, Higgins J (2005) Simultaneous comparison of multiple treatments: combining direct and indirect evidence. BMJ: Br Med J 331:897CrossRef
14.
Zurück zum Zitat Aletaha D, Landewe R, Karonitsch T, Bathon J, Boers M, Bombardier C, Bombardieri S, Choi H, Combe B, Dougados M (2008) Reporting disease activity in clinical trials of patients with rheumatoid arthritis: EULAR/ACR collaborative recommendations. Arthritis Care Res 59(10):1371–1377. https://doi.org/10.1002/art.24123 CrossRef Aletaha D, Landewe R, Karonitsch T, Bathon J, Boers M, Bombardier C, Bombardieri S, Choi H, Combe B, Dougados M (2008) Reporting disease activity in clinical trials of patients with rheumatoid arthritis: EULAR/ACR collaborative recommendations. Arthritis Care Res 59(10):1371–1377. https://​doi.​org/​10.​1002/​art.​24123 CrossRef
17.
Zurück zum Zitat Brown S, Hutton B, Clifford T, Coyle D, Grima D, Wells G, Cameron C (2014) A Microsoft-Excel-based tool for running and critically appraising network meta-analyses—an overview and application of NetMetaXL. Syst Rev 3:110 Brown S, Hutton B, Clifford T, Coyle D, Grima D, Wells G, Cameron C (2014) A Microsoft-Excel-based tool for running and critically appraising network meta-analyses—an overview and application of NetMetaXL. Syst Rev 3:110
18.
Zurück zum Zitat Salanti G, Ades A, Ioannidis JP (2011) Graphical methods and numerical summaries for presenting results from multiple-treatment meta-analysis: an overview and tutorial. J Clin Epidemiol 64:163–171 Salanti G, Ades A, Ioannidis JP (2011) Graphical methods and numerical summaries for presenting results from multiple-treatment meta-analysis: an overview and tutorial. J Clin Epidemiol 64:163–171
22.
Zurück zum Zitat Herman S, Zurgil N, Deutsch M (2005) Low dose methotrexate induces apoptosis with reactive oxygen species involvement in T lymphocytic cell lines to a greater extent than in monocytic lines. Inflamm Res 54:273–280CrossRefPubMed Herman S, Zurgil N, Deutsch M (2005) Low dose methotrexate induces apoptosis with reactive oxygen species involvement in T lymphocytic cell lines to a greater extent than in monocytic lines. Inflamm Res 54:273–280CrossRefPubMed
23.
Zurück zum Zitat Schmitz S, Adams R, Walsh CD, Barry M, FitzGerald O (2011) A mixed treatment comparison of the efficacy of anti-TNF agents in rheumatoid arthritis for methotrexate non-responders demonstrates differences between treatments: a Bayesian approach Annals of the Rheumatic Diseases: annrheumdis-2011-200228 Schmitz S, Adams R, Walsh CD, Barry M, FitzGerald O (2011) A mixed treatment comparison of the efficacy of anti-TNF agents in rheumatoid arthritis for methotrexate non-responders demonstrates differences between treatments: a Bayesian approach Annals of the Rheumatic Diseases: annrheumdis-2011-200228
Metadaten
Titel
Comparative efficacy and safety of biosimilar adalimumab and originator adalimumab in combination with methotrexate in patients with active rheumatoid arthritis: a Bayesian network meta-analysis of randomized controlled trials
verfasst von
Sang-Cheol Bae
Young Ho Lee
Publikationsdatum
01.02.2018
Verlag
Springer London
Erschienen in
Clinical Rheumatology / Ausgabe 5/2018
Print ISSN: 0770-3198
Elektronische ISSN: 1434-9949
DOI
https://doi.org/10.1007/s10067-018-4002-9

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