Comparable long-term efficacy, as assessed by @entity1 -reported outcomes, safety and pharmacokinetics, of CT-P13 and reference infliximab in @entity1 with XXXX : 54-week results from the randomized, parallel-group PLANETAS study.

@entity1 @entity281 @entity1691 @entity23561
BACKGROUND: CT-P13 (Remsima  , Inflectra  ) is a biosimilar of the infliximab @entity23561 ( @entity23561 ; Remicade  ) and is approved in Europe and elsewhere, mostly for the same indications as @entity23561 . The aim of this study was to compare the 54-week efficacy, immunogenicity, pharmacokinetics (PK) and safety of CT-P13 with @entity23561 in @entity1 with @entity1691 ( @entity1691 ), with a focus on @entity1 -reported outcomes (PROs). METHODS: This was a multinational, double-blind, parallel-group study in @entity1 with active @entity1691 . @entity1 were randomized (1:1) to receive CT-P13 (5  mg/kg) or @entity23561 (5  mg/kg) at weeks 0, 2, 6 and then every 8  weeks up to week 54. To assess responses, standardized assessment tools were used with an intention-to-treat analysis of observed data. Anti-drug antibodies (ADAs), PK parameters, and safety outcomes were also assessed. RESULTS: Of 250 randomized @entity1 (n   =   125 per group), 210 (84.0  %) completed 54  weeks of treatment, with similar completion rates between groups. At week 54, Assessment of Spondylo Arthritis international Society (ASAS)20 response, ASAS40 response and ASAS partial remission were comparable between treatment groups. Changes from baseline in PROs such as mean Bath @entity1691 Activity Index (BASDAI; CT-P13   -3.1 versus @entity23561 -2.8), Bath @entity1691 Functional Index (BASFI; -2.9 versus -2.7), and Short Form Health Survey (SF-36) scores (9.26 versus 10.13 for physical component summary; 7.30 versus 6.54 for mental component summary) were similar between treatment groups. At 54  weeks, 19.5  % and 23.0  % of @entity1 receiving CT-P13 and @entity23561 , respectively, had ADAs. All observed PK parameters of CT-P13 and @entity23561 , including maximum and minimum serum concentrations, were similar through 54  weeks. The influence of ADAs on PK was similar in the two treatment groups. Most adverse events were mild or moderate in severity. There was no notable difference between treatment groups in the incidence of adverse events, serious adverse events, @entity281 and infusion-related reactions. CONCLUSIONS: CT-P13 and @entity23561 have highly comparable efficacy (including PROs) and PK up to week 54. Over a 1-year period, CT-P13 was well tolerated and displayed a safety profile comparable to @entity23561 ; no differences in immunogenicity were observed. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01220518 . Registered 4 October 2010.
