The PROPER study: interim analysis of a pan-European real-world study of SB5 adalimumab biosimilar after transition from reference adalimumab in patients with Crohn’s disease

Introduction The ongoing real-world study ‘PROPER’ includes 1,000 patients with immune-mediated inflammatory disease, including Crohn’s disease (CD), treated at centres in Belgium, Germany, Ireland, Italy, Spain and the UK, and provides data on outcomes of the transition from reference to biosimilar adalimumab (ADL) SB5 outside the randomised, controlled, clinical trial setting.

Aims: To describe clinical characteristics and outcomes in patients (pts) with CD transitioned from reference to SB5.

Method: Eligible pts had been transitioned to SB5 as part of routine treatment following a minimum of 16 weeks’ treatment with reference ADL. Data are captured from patient charts retrospectively for 24 weeks prior to and prospectively and/or retrospectively for 48 weeks after SB5 initiation. Outcome measures include baseline clinical characteristics, disease activity, clinical management and safety.

Result: Of the 459 CD pts included in this interim analysis at time of data extract on 5^th February 2021, 108 had completed 48 weeks on SB5, 45 pts had discontinued SB5, and 10 had withdrawn from study. A disease flare was reported for 29 (6.3 %) pts, of whom 22 had no change in biologic treatment, 5 changed to a different biologic; 2 had secondary loss of response (physician reported). 12 pts reported 13 serious adverse events, 4 (anal fistula, 2 perianal abscesses and subileus) were considered by study physician to be related to SB5 administration.

Conclusion: The majority of pts in this contemporary study cohort of pts with established CD showed no meaningful difference in disease activity or SB5 dosing regimen by week 48 post-SB5 initiation. The Covid-19 pandemic had no apparent impact on SB5 use. No new safety concerns were detected.

Tab. 1 Patient characteristics; SB5 dose regimen and disease status over time; COVID-19 diagnosis

Age at baseline (years) Duration of disease (years since symptom onset)	n 457 354	Mean (SD) 43.5 (14.0) 13.8 (9.7)	95 % CI 42.2, 44.8 12.8, 14.8
Women	n 210	% 46.0	-
Clinical status at baseline (physician opinion): In remission Stable Active disease	n 230 168 49	% 51.5 37.6 11.0	---
SB5 dosing regimen: 40 mg Q2W: Baseline Week 48 Other*: Baseline Week 48	n/N 341/459 113/154 118/459 41/154	% 74.3 73.4 25.7 26.6	----
Disease score (paired patients), HBI Baseline Week 48	n 159 159	Mean (SD) 2.5 (2.8) 3.1 (3.6)	95 % CI 2.1, 3.0 2.6, 3.7
Patient diagnosed with COVID-19 at any time during the study? No Yes Unknown	n 308 5 22	% 91.9 1.5 6.6	---
Stop or change in SB5 regimen due to COVID-19 pandemic? No Yes	n 307 1	% 99.7 0.3	--
CI, confidence interval; HBI, Harvey Bradshaw Index; Q2W, once every two weeks; SD, standard deviation. *Other includes all other reported doses and/or dosing intervals: 40 mg Weekly, 80 mg Q2W, and unspecified frequency. Baseline refers to the time of SB5 initiation.

Publication History

Article published online:
07 September 2021