To switch or not to switch: results of a nationwide guideline of mandatory switching from originator to biosimilar etanercept. One-year treatment outcomes in 2061 patients with inflammatory arthritis from the DANBIO registry

Abstract

ObjectivesReal-world evidence on effectiveness of switching to biosimila r etanercept is scarce. In Denmark, a nationwide guideline of mandatory switch from 50 mg originator (ETA) to biosimilar (SB4) etanercept was issued for patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritis (AxSpA) in 2016. Clinical characteristics and treatment outcomes were studied in ETA-treated patients, who switched to SB4 (switchers) or maintained ETA (non-switchers). Retention rates were compared with that of a historic cohort of ETA-treated patients. Switchers who resumed ETA treatment (back-switchers) were characterised.MethodsObservational cohort study based on the DANBIO registry. Treatment retention was explored by Kaplan-Meier plots and Cox regression (crude, adjusted).Results1621 (79%) of 2061 ETA-treated patients switched to SB4. Disease activity was unchanged 3 months’ preswitch/postswitch. Non-switchers often received 25 mg ETA (ETA 25 mg pens/syringes and powder solution were still available). One-year adjusted retention rates were: non-switchers: 77% (95% CI: 72% to 82%)/switchers: 83% (79% to 87%)/historic cohort: 90% (88% to 92%). Patients not in remission had lower retention rates than patients in remission, both in switchers (crude HR 1.7 (1.3 to 2.2)) and non-switchers (2.4 (1.7 to 3.6)). During follow-up, 120 patients (7% of switchers) back-switched to ETA. Back-switchers’ clinical characteristics were similar to switchers, and reasons for SB4 withdrawal were mainly subjective.ConclusionSeventy-nine per cent of patients switched from ETA to SB4. After 1 year, adjusted treatment retention rates were lower in switchers versus the historic ETA cohort, but higher than in non-switchers. Withdrawal was more common in patients not in remission. The results suggest that switch outcomes in routine care are affected by patient-related factors and non-specific drug effects.

Consensus report: clinical recommendations for the prevention and management of the nocebo effect in biosimilar‐treated IBD patients

“…But the majority of patients is not familiar with biosimilars, and three quarters of those who are, have concerns about them . Furthermore, “forced switching” is a reality that some countries and organisations face, which might lead to an increased risk of the nocebo effect.…”

The Future of Biosimilars: Maximizing Benefits Across Immune-Mediated Inflammatory Diseases

“…In the European Economic Area, biosimilar competition has already reduced average list prices and increased patient access to biologics [10]. Growing real-world evidence with biosimilars [11][12][13] is helping to support clinical use, increasing confidence in biosimilars. However, many patients are still treated with RPs, partly because of ongoing physician and patient concerns about biosimilars.…”

Who is afraid of biosimilars? Openness to biosimilars in an Australian cohort of patients with rheumatoid arthritis

“…Real-world data from the Danish registry suggest that patients who switched back from biosimilar to bio-originator etanercept were due to changes in disease activity and adverse effects that were subjective rather than objective. 16 Similar reasons were attributed to the discontinuation of biosimilar infliximab in the Dutch open-label trial. 4 In conclusion, our study of patient attitudes towards biosimilars in Australia illustrated a high baseline biosimilar acceptance.…”

“…Patients that initially accept biosimilars may refuse them later due to the nocebo effect as well as the potential social desirability bias. Real‐world data from the Danish registry suggest that patients who switched back from biosimilar to bio‐originator etanercept were due to changes in disease activity and adverse effects that were subjective rather than objective . Similar reasons were attributed to the discontinuation of biosimilar infliximab in the Dutch open‐label trial …”