Background/Purpose: SB5, an adalimumab biosimilar 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 reference adalimumab (ADL). There are few published data on the transition from reference ADL to SB5 outside the controlled, randomised, clinical trial setting. This study aims 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 (axSpA) or psoriatic arthritis (PsA), 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 the 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; 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 and dose regimen up to 24 weeks post-initiation of SB5 in subjects with RA, axSpA or PsA enrolled at 16 specialist sites (11 in Germany, 5 in UK), followed up to the data extract date of 1^st May 2020.

Results:

Of the 256 patients included in this interim analysis 85 with RA and 23 with PsA were enrolled in Germany, and 86 with axSpA and 62 with PsA in U.K.

Conclusion:

This interim analysis provides an early insight into a contemporary cohort of EU patients with established RA, axSpA and PsA, switched from reference to biosimilar ADL in clinical practice. The majority of patients had stable disease at transition, with no meaningful difference seen in disease score by Week 24 post-transition, while 75% or more of each cohort transitioned to the same dose regimen of SB5 as received for reference ADL prior to transition, and the majority of patients continued the same SB5 regimen to Week 24. With ongoing enrolment and longer follow-up, the study will provide pertinent information about clinical outcomes of transition from reference to biosimilar ADL in real-world practice and in indications not investigated in controlled studies.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/the-proper-study-results-of-the-first-interim-analysis-of-a-pan-eu-real-world-study-of-sb5-biosimilar-following-transition-from-reference-adalimumab-in-patients-with-rheumatoid-arthritis-axial-spond/