gms | German Medical Science

Introduction: SB5, a biosimilar to reference adalimumab (ADL), received EU marketing authorisation in August 2017, based on evidence from pre-clinical and clinical Phase I and III studies demonstrating bioequivalence, similar efficacy, and comparable safety and immunogenicity to the reference. This real-world study provides data on outcomes of the transition from reference to biosimilar ADL outside the controlled, randomised, clinical trial setting to evaluate candidate predictors of persistence on SB5 in EU patients across multiple indications.

Methods: This ongoing observational study enrolled 1000 subjects with rheumatoid arthritis (RA), axial spondyloarthritis, psoriatic arthritis (PsA), ulcerative Colitis or Crohn’s disease who initiated SB5 within routine clinical practice following a minimum of 16 weeks’ treatment with reference ADL, at clinics in Belgium, Germany, Ireland, Italy, Spain, and the UK. Data are captured from clinic records retrospectively for the 24 weeks prior to transition, and prospectively and/or retrospectively for 48 weeks following transition. Primary outcome measures include baseline clinical characteristics, disease activity scores and clinical management over time. This interim analysis provides an overview of baseline characteristics, and disease scores up to 48 weeks post-initiation of SB5 for subjects with RA and PsA enrolled at 11 specialist sites in Germany followed up to the data extract date of 05th February 2021.

Results: Of the 145 patients included in this interim analysis, 112 have RA, and 33 have PsA. At time of data extract, 89 patients had completed 48 weeks on SB5. Within the RA patients 50.0 % are on concomitant MTX therapy, and 24.1 % receive concomitant corticosteroids. 3 patients reported serious adverse events of breast cancer and gastrostomy, pneumonia and herpes zoster, the latter two were considered related to SB5 therapy.

Conclusion: This interim analysis provides an early insight into a contemporary cohort of German patients with established RA and PsA, switched from reference ADL to SB5 in clinical practice. The majority of patients had stable disease at transition and, thus far, baseline disease score was maintained for the duration of follow-up within the RA cohort. No safety concerns were detected. This ongoing study is expected to provide pertinent information on long-term clinical outcomes.

Table 1 [Tab. 1], Table 2 [Tab. 2]

Disclosures: Ulf Müller-Ladner Speaker and Advisor for Biogen; Caroline Mohr Shareholder and Employee of Biogen; Janet Addison Shareholder and Employee of Biogen