TY - JOUR
T1 - Comparative efficacy and safety of biosimilar-infliximab and originator-infliximab in combination with methotrexate in patients with active rheumatoid arthritis
T2 - a meta-analysis of randomized controlled trials
AU - Bae, Sang Cheol
AU - Lee, Young Ho
N1 - Funding Information:
This study was supported in part by a grant from the Korea Healthcare technology R&D Project, Ministry for Health and Welfare, Republic of Korea (HI15C2958).
Publisher Copyright:
© 2018 Asia Pacific League of Associations for Rheumatology and John Wiley & Sons Australia, Ltd
PY - 2018/5
Y1 - 2018/5
N2 - Objective: We aimed to assess the relative efficacy and safety of biosimilar-infliximab and originator-infliximab in combination with methotrexate (MTX) compared to placebo plus MTX in active rheumatoid arthritis (RA). Methods: 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 infliximab + MTX and placebo + MTX (MTX group) in patients with active RA despite treatment with MTX. Results: Seven RCts involving 2606 patients met the inclusion criteria. The American College of Rheumatology (ACR)20 response rate was significantly higher in the biosimilar + MTX group than in the MTX group (odds ratio [OR] 3.31, 95% credible interval [CrI] 1.74–6.06). Similarly, the ACR20 response rate was significantly higher in the infliximab + MTX group than in the MTX group (OR 3.15, 95% CrI 1.99–4.70). There was no difference in the ACR20 response rate between the biosimilar+ MTX and infliximab + MTX groups. Ranking probability based on surface under the cumulative ranking curve (SUCRA) indicated that treatment with biosimilar + MTX had the highest probability of achieving the ACR20 response rate (SUCRA = 0.7964), followed by infliximab + MTX (SUCRA = 0.7018) and MTX alone (SUCRA = 0.0018). The ACR50 and ACR70 response rates showed a similar distribution pattern to the ACR20 response rate. By contrast, the safety based on the number of serious adverse events (SAEs) did not differ significantly among the three interventions. Conclusions: Biosimilar- and originator-infliximab, in combination with MTX, represent effective interventions for active RA, with a low risk of SAEs. No significant difference between biosimilar- and originator-infliximab was found in terms of efficacy and safety.
AB - Objective: We aimed to assess the relative efficacy and safety of biosimilar-infliximab and originator-infliximab in combination with methotrexate (MTX) compared to placebo plus MTX in active rheumatoid arthritis (RA). Methods: 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 infliximab + MTX and placebo + MTX (MTX group) in patients with active RA despite treatment with MTX. Results: Seven RCts involving 2606 patients met the inclusion criteria. The American College of Rheumatology (ACR)20 response rate was significantly higher in the biosimilar + MTX group than in the MTX group (odds ratio [OR] 3.31, 95% credible interval [CrI] 1.74–6.06). Similarly, the ACR20 response rate was significantly higher in the infliximab + MTX group than in the MTX group (OR 3.15, 95% CrI 1.99–4.70). There was no difference in the ACR20 response rate between the biosimilar+ MTX and infliximab + MTX groups. Ranking probability based on surface under the cumulative ranking curve (SUCRA) indicated that treatment with biosimilar + MTX had the highest probability of achieving the ACR20 response rate (SUCRA = 0.7964), followed by infliximab + MTX (SUCRA = 0.7018) and MTX alone (SUCRA = 0.0018). The ACR50 and ACR70 response rates showed a similar distribution pattern to the ACR20 response rate. By contrast, the safety based on the number of serious adverse events (SAEs) did not differ significantly among the three interventions. Conclusions: Biosimilar- and originator-infliximab, in combination with MTX, represent effective interventions for active RA, with a low risk of SAEs. No significant difference between biosimilar- and originator-infliximab was found in terms of efficacy and safety.
KW - biosimilar
KW - infliximab
KW - network meta-analysis
KW - rheumatoid arthritis
UR - http://www.scopus.com/inward/record.url?scp=85047960739&partnerID=8YFLogxK
U2 - 10.1111/1756-185X.13305
DO - 10.1111/1756-185X.13305
M3 - Article
C2 - 29671942
AN - SCOPUS:85047960739
VL - 21
SP - 922
EP - 929
JO - APLAR Journal of Rheumatology
JF - APLAR Journal of Rheumatology
SN - 1756-1841
IS - 5
ER -