Efficacy and safety of infliximab-biosimilar compared to other biological drugs in rheumatoid arthritis: a mixed treatment comparison

Abstract

ObjectiveThe aim of this meta-analysis was to compare the efficacy and safety of infliximab-biosimilar and other available biologicals for the treatment of rheumatoid arthritis (RA), namely abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab and tocilizumab.MethodsA systematic literature review of MEDLINE database until August 2013 was carried out to identify relevant randomized controlled trials (RCTs). Bayesian mixed treatment comparison method was applied for the pairwise comparison of treatments. Improvement rates by the American College of Rheumatology criteria (ACR20 and ACR50) at week 24 were used as efficacy endpoints, and the occurrence of serious adverse events was considered to assess the safety of the biologicals.ResultsThirty-six RCTs were included in the meta-analysis. All the biological agents proved to be superior to placebo. For ACR20 response, certolizumab pegol showed the highest odds ratio (OR) compared to placebo, OR 7.69 [95 % CI 3.69–14.26], followed by abatacept OR 3.7 [95 % CI 2.17–6.06], tocilizumab OR 3.69 [95 % CI 1.87–6.62] and infliximab-biosimilar OR 3.47 [95 % CI 0.85–9.7]. For ACR50 response, certolizumab pegol showed the highest OR compared to placebo OR 8.46 [3.74–16.82], followed by tocilizumab OR 5.57 [95 % CI 2.77–10.09], and infliximab-biosimilar OR 4.06 [95 % CI 1.01–11.54]. Regarding the occurrence of serious adverse events, the results show no statistically significant difference between infliximab-biosimilar and placebo, OR 1.87 [95 % CI 0.74–3.84]. No significant difference regarding efficacy and safety was found between infliximab-biosimilar and the other biological treatments.ConclusionThis is the first indirect meta-analysis in RA that compares the efficacy and safety of biosimilar-infliximab to the other biologicals indicated in RA. We found no significant difference between infliximab-biosimilar and other biological agents in terms of clinical efficacy and safety.

Biosimilars for the management of rheumatoid arthritis: economic considerations

“…These data were supported by the findings of a Phase I trial in patients with ankylosing spondylitis (AS) [47]. Two metaanalyses have also confirmed that CT-P13 possesses efficacy and safety profiles similar to other biologic drugs, both in RA and AS [48,49]. In these analyses, CT-P13 was compared with several RMP biologics, namely infliximab, abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, rituximab and tocilizumab.…”

Pharmacokinetics, safety, tolerability and immunogenicity of FKB327, a new biosimilar medicine of adalimumab/Humira, in healthy subjects

“…This study was done at Hammersmith Medicines Research, a clinical pharmacology unit in the UK, in accordance with the prevailing EU directives and International Conference on Harmonisation Good Clinical Practice. After review of the safety profile of adalimumab, and the safety record of monoclonal antibody studies in healthy subjects, we considered it acceptable to do the study [6,[12][13][14][15]. The study was not started until it had received approval from the Medicines and Healthcare products Regulatory Agency (MHRA; EudraCT number: 2012-005140-23), and Scotland A Research Ethics Committee (reference number: 12/SS/0220).…”

Treatment preferences of originator versus biosimilar drugs in Crohn’s disease; discrete choice experiment among gastroenterologists

“…These drugs were registered under the same conditions as the originator infliximab for the treatment of six adult conditions and in two pediatric indications. Nevertheless, randomized clinical trials (RCT) have been carried out only in two adult rheumatic disorders: a non-inferiority study in rheumatoid arthritis and another in anklyosing spondylitis [1,2]. These studies did not find significant differences either in efficacy or in safety between the originator and the biosimilar substance [3,4].…”

“…Biosimilar infliximab drugs (brand names Remsima Ô and Inflectra Ô ) are the first biosimilar monoclonal antibody medicines in chronic inflammatory conditions approved by the European Medicine Agency in 2013 [1,2]. These drugs were registered under the same conditions as the originator infliximab for the treatment of six adult conditions and in two pediatric indications.…”