Comparing biosimilar SB2 with reference infliximab after 54 weeks of a double-blind trial: clinical, structural and safety results

Abstract

ObjectivesSB2 is a biosimilar to the reference infliximab (INF). Similar efficacy, safety and immunogenicity between SB2 and INF up to 30 weeks were previously reported. This report investigates such clinical similarity up to 54 weeks, including structural joint damage.MethodsIn this phase III, double-blind, parallel-group, multicentre study, patients with moderate to severe RA despite MTX were randomized (1:1) to receive 3 mg/kg of either SB2 or INF at 0, 2, 6 and every 8 weeks thereafter. Dose escalation by 1.5 mg/kg up to a maximum dose of 7.5 mg/kg was allowed after week 30. Efficacy, safety and immunogenicity were measured at each visit up to week 54. Radiographic damage evaluated by modified total Sharp score was measured at baseline and week 54.ResultsA total of 584 patients were randomized to receive SB2 (n = 291) or INF (n = 293). The rate of radiographic progression was comparable between SB2 and INF (mean modified total Sharp score difference: SB2, 0.38; INF, 0.37) at 1 year. ACR responses, 28-joint DAS, Clinical Disease Activity Index and Simplified Disease Activity Index were comparable between SB2 and INF up to week 54. The incidence of treatment-emergent adverse events and anti-drug antibodies were comparable between treatment groups. Such comparable trends of efficacy, safety and immunogenicity were consistent from baseline up to 54 weeks. The pattern of dose increment was also comparable between SB2 and INF.ConclusionSB2 maintained similar efficacy, safety and immunogenicity with INF up to 54 weeks in patients with moderate to severe RA. Radiographic progression was comparable at 1 year.Trial registrationClinicalTrials.gov (http://clinicaltrials.gov; NCT01936181) and EudraCT (https://www.clinicaltrialsregister.eu; 2012-005733-37)

Long‐term efficacy and safety of biosimilar infliximab (CT‐P13) after switching from originator infliximab: open‐label extension of the NOR‐SWITCH trial

“…Biosimilars are reproductions of their originator counterparts, are usually less expensive and therefore provide a potential opportunity to improve patient access. An increasing number of biosimilars are coming into clinical use [3], and so far, no clinical studies have shown any unexpected effects of starting patients on a biosimilar instead of an originator drug [4][5][6][7][8]. However, to achieve a significant impact on health budgets, it is not sufficient that only new patients starting biologic therapy are prescribed biosimilars.…”

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

“…A total of 1252 studies were identified through electronic searches, and 13 studies were selected for a full‐text review based on the title and abstract details (). However, six of the 13 studies were excluded, because of duplication ( n = 2), MTX‐naïve patients ( n = 2), no data on ACR response data ( n = 1) and short follow‐up period ( n = 1) (). A study by Abe et al .…”

“…was not included, because the study did not provide data on ACR response as the efficacy outcome. Thus, seven RCTs that included 2606 patients (1316 events for efficacy and 262 events for safety) met the inclusion criteria (Table ). All the RCTs provided data on efficacy and safety.…”

“…Because of the growing availability of biosimilars, it is important to combine the available data and to provide objective quantitative estimates of the efficacy and safety of biosimilars. Several clinical trials have attempted to evaluate the efficacy and safety of biosimilar + MTX versus infliximab + MTX and infliximab + MTX versus placebo + MTX in patients with active RA who have experienced an incomplete response to MTX . However, to our knowledge, no previous studies have directly compared biosimilar + MTX and placebo + MTX.…”

“…Several clinical trials have attempted to evaluate the efficacy and safety of biosimilar + MTX versus infliximab + MTX and infliximab + MTX versus placebo + MTX in patients with active RA who have experienced an incomplete response to MTX. [6][7][8][9][10][11][12] However, to our knowledge, no previous studies have directly compared biosimilar + MTX and placebo + MTX. Network meta-analyses enable an assessment of the comparative effectiveness of multiple interventions and combine evidence across a network of randomized controlled trials (RCTs), even in the absence of head-to-head comparisons.…”