Background/Purpose: Over the past decade, the use of biologics has significantly changed the management of rheumatoid arthritis (RA) and ankylosing spondylitis (AS). However, the high cost of biologics imposes limits on their use, particularly in developing countries. The development and commercialization of biosimilars can help address unmet medical needs by improving access to well-established therapeutic interventions while improving healthcare affordability. CT- P13 was the first monoclonal antibody biosimilar approved in the EU, as well as recently by the FDA. The study objective was to demonstrate the safety and effectiveness of CT- P13 when administered in a real-life setting in adults with active RA or AS.

Methods: This multicenter, non-interventional, observational study was conducted in Romania, Czech Republic and Bulgaria in patients with severe, progressive RA (with inadequate response to methotrexate /other DMARDs) or severe AS (with inadequate response to conventional therapy). Study investigators determined specific doses/timing of infusions based on the CT- P13 SPC. Patients received CT- P13 at baseline (visit 1), week 2 (visit 2), week 6 (visit 3), between weeks 12 and 14 (visit 4: month 3). Safety was assessed by early dropouts and adverse events (AEs). Effectiveness was assessed at baseline and visit 4 (month 3) using the Disease Activity Score (DAS28) for RA patients and the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) for AS patients.

Results: At 14 June 2016, 151 subjects (47% male, mean [SD] age 48.9 [14.1] years) have been enrolled (median follow-up 159 days). At visit 4 (month 3), mean (SD) CT- P13 doses were 240 (61) mg/3.3 (0.6) mg/kg for RA, and 384 (87) mg/5.0 (0.5) mg/kg for AS. There were 31 AEs: 5 definitely related, 0 probable related, 5 possibly related, and 21 unrelated to CT- P13. Among the AEs related to CT- P13 treatment 5 were mild, 3 moderate and 2 severe. Altogether 16 patients have been withdrawn prematurely from the study so far, and in 6 cases AE was listed as reason for dropout. Last available observation were carried forward (LOCF) for patients who did not have effectiveness measurement at visit 4 due to early termination. Thus, 111 patients (RA: 61; AS: 50) have baseline and follow-up primary effectiveness measurements at month 3 so far. After 3 months of CT- P13 treatment, patients showed significant improvements in disease activity relative to baseline in terms of DAS28 (baseline: mean [SD]=5.8 [1.0], month 3: mean [SD]=3.6 [1.6]; t=10.5, df=60, p<0.0001, Cohen’s d=1.7) and BASDAI (baseline: mean [SD]=6.8 [1.7], month 3: mean [SD]=3.4 [2.3]; t=11.6, df=49, p<0.0001, Cohen’s d=1.7). Patients with RA and AS analyzed together showed a significant decrease in C-reactive protein (CRP) levels after 3 months. (baseline: mean [SD]=26.3 [23.6], month 3: mean [SD]=10.2 [17.6]; t=6.0, df=105, p<0.0001, Cohen’s d=0.8).

Conclusion: CT- P13 (biosimilar reference infliximab) is safe and effective in a real-life setting in patients with RA or AS.

« Back to 2016 ACR/ARHP Annual Meeting

ACR Meeting Abstracts - https://acrabstracts.org/abstract/effectiveness-and-safety-of-ct-p13-biosimilar-reference-infliximab-in-a-real-life-setting-in-151-patients-with-rheumatoid-arthritis-and-ankylosing-spondylitis-a-mid-term-interim-analysis/