Network meta-analysis of infliximab biosimilars for the treatment of rheumatoid arthritis

被引:7
作者
Hanrahan, Conor [1 ]
Lee, Todd [2 ]
机构
[1] Intermt Healthcare Pharm Serv, Taylorsville, UT 84129 USA
[2] Univ Illinois, Coll Pharm, Dept Pharm Syst Outcomes & Policy, Chicago, IL USA
关键词
biosimilar pharmaceuticals; evidence-based medicine; infliximab; meta-analysis; rheumatoid arthritis; tumor necrosis factor inhibitors;
D O I
10.1093/ajhp/zxab042
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
Purpose. This article assesses the relative efficacy and safety of infliximab biosimilars in treatment of patients with rheumatoid arthritis (RA). Methods. A frequentist, random-effects network meta-analysis was performed to evaluate evidence from randomized controlled trials that examined the use of infliximab biosimilars for treatment of patients with RA. PubMed/MEDLINE and other sources were searched for reports evaluating rates of response to treatment with the reference product (infliximab) vs an infliximab biosimilar. The primary efficacy outcome of interest was the rate of attainment of ACR20 (ie, 20% improvement in American College of Rheumatology core measures). The primary safety outcome was the rate of treatment-related serious adverse events (SAEs). Data were extracted by the primary author, and an assessment for risks of methodological bias was performed for each evaluated study. Results. Five studies that enrolled a total of 2,499 patients were included. Overall comparisons using odds ratios and 95% confidence intervals (CIs) did not indicate statistically significant differences in response to treatment with biosimilar agents relative to each other or the infliximab reference product. ORs for ACR20 response for biosimilars vs infliximab were as follows: 1.475 (95% CI, 0.940-2.315) for infliximab-axxq, 1.259 (95% CI, 0.854-1.855) for infliximab-dyyb, 0.865 (95% CI, 0.5511.358) for infliximab-qbtx, and 0.832 (95% CI, 0.506-1.367) for infliximab-abda. Similar findings were observed in reported SAE rates among patients treated with the various biosimilars. Conclusion. ACR20 response appears to be comparable and nonsignificantly different between infliximab biosimilars. In the absence of any meaningful differences in safety or efficacy, biosimilar cost may be the deciding factor in choosing a treatment or agent for formulary inclusion.
引用
收藏
页码:697 / 704
页数:8
相关论文
共 25 条
[1]  
[Anonymous], 2020, IPD AN
[2]  
[Anonymous], 2020, **DROPPED REF**
[3]  
[Anonymous], 2020, LEX ONL PROPR DAT
[4]   Comparative efficacy and safety of biosimilar-infliximab and originator-infliximab in combination with methotrexate in patients with active rheumatoid arthritis: a meta-analysis of randomized controlled trials [J].
Bae, Sang-Cheol ;
Lee, Young Ho .
INTERNATIONAL JOURNAL OF RHEUMATIC DISEASES, 2018, 21 (05) :922-929
[5]   A randomized controlled trial comparing PF-06438179/GP1111 (an infliximab biosimilar) and infliximab reference product for treatment of moderate to severe active rheumatoid arthritis despite methotrexate therapy [J].
Cohen, Stanley B. ;
Alten, Rieke ;
Kameda, Hideto ;
Hala, Tomas ;
Radominski, Sebastiao C. ;
Rehman, Muhammad I. ;
Palaparthy, Ramesh ;
Schumacher, Karl ;
Schmitt, Susanne ;
Hua, Steven Y. ;
Ianos, Claudia ;
Sewell, K. Lea .
ARTHRITIS RESEARCH & THERAPY, 2018, 20
[6]  
FDA, GUID IND RHEUM ARTHR
[7]   A proposed revision to the ACR20:: The hybrid measure of American College of Rheumatology response [J].
Felson, David ;
Aletaha, Daniel ;
Anderson, Jennifer ;
Bathon, Joan ;
Boers, Maarten ;
Bombardier, Claire ;
Choi, Hyon ;
Dougados, Maxine ;
Furst, Dan ;
Koch, Gary ;
Landewe, Robert ;
LaValley, Mike ;
Michaud, Kaleb ;
Paulus, Hal ;
Pincus, Theodore ;
Siegel, Jeffrey ;
Simon, Lee ;
Smolen, Josef ;
Tugwell, Peter ;
van der Heijde, Desiree ;
White, Barbara ;
Wolfe, Fred ;
Xie, Hui .
ARTHRITIS & RHEUMATISM-ARTHRITIS CARE & RESEARCH, 2007, 57 (02) :193-202
[8]   THE AMERICAN-COLLEGE-OF-RHEUMATOLOGY PRELIMINARY CORE SET OF DISEASE-ACTIVITY MEASURES FOR RHEUMATOID-ARTHRITIS CLINICAL-TRIALS [J].
FELSON, DT ;
ANDERSON, JJ ;
BOERS, M ;
BOMBARDIER, C ;
CHERNOFF, M ;
FRIED, B ;
FURST, D ;
GOLDSMITH, C ;
KIESZAK, S ;
LIGHTFOOT, R ;
PAULUS, H ;
TUGWELL, P ;
WEINBLATT, M ;
WIDMARK, R ;
WILLIAMS, HJ ;
WOLFE, F .
ARTHRITIS AND RHEUMATISM, 1993, 36 (06) :729-740
[9]   AGA Clinical Practice Guidelines on the Management of Moderate to Severe Ulcerative Colitis [J].
Feuerstein, Joseph D. ;
Isaacs, Kim L. ;
Schneider, Yecheskel ;
Siddique, Shazia Mehmood ;
Falck-Ytter, Yngve ;
Singh, Siddharth .
GASTROENTEROLOGY, 2020, 158 (05) :1450-1463
[10]   Comparative clinical efficacy and safety of the proposed biosimilar ABP 710 with infliximab reference product in patients with rheumatoid arthritis [J].
Genovese, Mark C. ;
Sanchez-Burson, Juan ;
Oh, MyungShin ;
Balazs, Eva ;
Neal, Jeffrey ;
Everding, Andrea ;
Hala, Tomas ;
Wojciechowski, Rafal ;
Fanjiang, Gary ;
Cohen, Stanley .
ARTHRITIS RESEARCH & THERAPY, 2020, 22 (01)