gms | German Medical Science

Background: SB4, a biosimilar to the reference ETN, received EU marketing authorisation in January 2016, based on the totality of evidence from pre-clinical and clinical Phase I and III studies that demonstrated similar efficacy, bioequivalence, and comparable safety and immunogenicity to ETN. There are few published data on outcomes of transition from originator to biosimilar outside the controlled setting of randomised clinical trials.

Objectives: Provide real world evidence on transition and outcomes of treatment switch in routine clinical practice.

Methods: This ongoing observational study will enrol 600 subjects with RA or axSpA, who initiated SB4 as part of routine clinical practice following a minimum of 6 months treatment with a stable dose of originator ETN, at clinics in France, Germany, Italy and Spain. Data are captured from clinic records, retrospectively for 6 months prior to switch and prospectively and/or retrospectively for 6 months following switch. Outcome measures include disease score (DAS-28 for RA, BASDAI for axSpA) over time, clinical characteristics and management, and adverse events. This interim analysis (IA) provides a descriptive review of baseline characteristics and 3-month effectiveness measures for all eligible subjects enrolled in the study database by 22nd March 2018.

Results: Of the 160 subjects included, 107 have RA and 53 axSpA (Table 1 [Tab. 1]).

Conclusion: This interim analysis provides an early insight into disease status and outcomes in a contemporary cohort of EU patients with established RA and axSpA, switched from originator to biosimilar ETN in clinical practice. In this relatively small sample size, disease status after transition appeared to remain stable. Further insights will be generated as the study progresses to full sample size and outcomes up to 6 months post-transition reported.