gms | German Medical Science

Background: SB5, a biosimilar to reference adalimumab (ADL), received EU marketing authorisation in August 2017, based on the totality of evidence from pre-clinical and clinical Phase I and III studies that demonstrated bioequivalence, similar efficacy, and comparable safety and immunogenicity to the reference. There are few published data on the transition from reference to biosimilar ADL outside the controlled, randomised, clinical trial setting.

Objectives: To evaluate candidate predictors of persistence on SB5 in EU patients across multiple indications.

Methods: This ongoing observational study will enrol approximately 1200 subjects with rheumatoid arthritis (RA), axial spondyloarthritis, psoriatic arthritis, ulcerative colitis or Crohn’s disease who initiated SB5 as part of 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 24 weeks prior to transition, and prospectively and/or retrospectively for 48 weeks following transition. The primary objective is to evaluate candidate predictors of persistence, and primary outcome measures include baseline clinical characteristics, disease activity scores, clinical management and patient satisfaction over time. This interim analysis (IA) provides an overview of baseline characteristics and disease scores over time for subjects with RA enrolled at 11 specialist sites in Germany and followed up to the data extract date of 20 March 2020.

Results: This IA includes 84 patients (Table 1 [Tab. 1]).

Conclusion: This IA provides an early insight into a contemporary cohort of German patients with established RA, switched from reference to biosimilar ADL 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. Most patients are aware of correct storage and self-administration of their biosimilar medication, and 76.5 % transitioned to the same dose regimen of biosimilar as had been received for the reference. No safety concerns were detected. This ongoing study is expected to provide pertinent information on long-term clinical outcomes.

Disclosures: Biogen International GmbH funded this study. Authors had full editorial control and provided final approval of all content.

JA, MU are employees of and may hold stock in Biogen.