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

OBJECTIVES:

Real-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.

METHODS:

Observational cohort study based on the DANBIO registry. Treatment retention was explored by Kaplan-Meier plots and Cox regression (crude, adjusted).

RESULTS:

1621 (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.

CONCLUSION:

Seventy-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.

• Authors: Bente Glintborg, Anne Gitte Loft, Emina Omerovic, Oliver Hendricks, Asta Linauskas, Jakob Espesen, Kamilla Danebod, Dorte Vendelbo Jensen, Henrik Nordin, Emil Barner Dalgaard, Stavros Chrysidis, Salome Kristensen, Johnny Lillelund Raun, Hanne Lindegaard, Natalia Manilo, Susanne Højmark Jakobsen, Inger Marie Jensen Hansen, Dorte Dalsgaard Pedersen, Inge Juul Sørensen, Lis Smedegaard Andersen, Jolanta Grydehøj, Frank Mehnert, Niels Steen Krogh, Merete Lund Hetland
• Journal: Annals of the rheumatic diseases (Ann Rheum Dis) Vol. 78 Issue 2 Pg. 192-200 (02 2019) ISSN: 1468-2060 [Electronic] England
• PMID: 30396903 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: © Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and permissions. Published by BMJ.

Chemical References

• Antirheumatic Agents
• Biosimilar Pharmaceuticals
• Etanercept

Topics

• Adult
• Antirheumatic Agents (administration & dosage, standards)
• Arthritis, Psoriatic (drug therapy)
• Arthritis, Rheumatoid (drug therapy)
• Biosimilar Pharmaceuticals (administration & dosage, standards)
• Denmark
• Drug Substitution (methods, standards)
• Etanercept (administration & dosage, standards)
• Female
• Humans
• Male
• Middle Aged
• Registries
• Spondylarthritis (drug therapy)
• Treatment Outcome