Outcomes Following a Mandatory Nonmedical Switch From Adalimumab Originator to Adalimumab Biosimilars in Patients With Psoriasis.
Journal
JAMA dermatology
ISSN: 2168-6084
Titre abrégé: JAMA Dermatol
Pays: United States
ID NLM: 101589530
Informations de publication
Date de publication:
01 Jun 2021
01 Jun 2021
Historique:
pubmed:
8
4
2021
medline:
26
3
2022
entrez:
7
4
2021
Statut:
ppublish
Résumé
The efficacy of adalimumab biosimilars is similar to that of brand-name adalimumab (Humira, hereinafter originator) in clinical trials. However, limited knowledge about real-world data exists for adalimumab biosimilars. To assess the outcomes following a mandatory nonmedical switch from adalimumab originator to adalimumab biosimilars in patients with psoriasis. This cohort study assesses the outcomes following a switch from adalimumab originator to an adalimumab biosimilar. Patients in the Biological Treatment in Danish Dermatology (DERMBIO) registry, a Danish nationwide registry of all patients treated with biologics (including biosimilars) for psoriasis since 2007, were assessed for eligibility. All patients who switched from adalimumab originator to an adalimumab biosimilar between November 1, 2018, and May 1, 2019, were included in the adalimumab biosimilar cohort. All patients with a visit between May 1, 2017, and November 1, 2017, treated with adalimumab originator were included in the adalimumab originator cohort. Data were analyzed from June 1, 2020, to October 10, 2021. Switch from adalimumab originator to an adalimumab biosimilar. The primary outcome was 1-year drug retention in patients switching to adalimumab biosimilars compared with patients treated with adalimumab originator. Crude and adjusted retention rates for the adalimumab biosimilar cohort were compared with the adalimumab originator cohort with Cox proportional hazards regression using robust variance. A total of 348 patients were included in the adalimumab biosimilar cohort (mean [SD] age, 52.2 [13.6] years; 251 [72.1%] male) and 378 patients in the adalimumab originator cohort (mean [SD] age, 51.1 [14.1] years; 272 [72.0%] male). The 1-year drug retention rates were 92.0% (95% CI, 89.0%-94.9%) for the adalimumab biosimilar cohort and 92.1% (95% CI, 89.4%-94.8%) for the adalimumab originator cohort. Similar hazard ratios were observed between the 2 cohorts. The crude hazard ratios were 1.02 (95% CI, 0.61-1.70; P = .94) for all causes of drug discontinuation, 0.82 (95% CI, 0.39-1.73; P = .60) for insufficient effect, and 1.41 (95% CI, 0.52-3.77; P = .50) for adverse events for the adalimumab biosimilar cohort when compared with the adalimumab originator cohort. In this cohort study from Denmark, a nonmedical switch from adalimumab originator to adalimumab biosimilars was not associated with drug retention.
Identifiants
pubmed: 33825804
pii: 2778168
doi: 10.1001/jamadermatol.2021.0221
pmc: PMC8027941
doi:
Substances chimiques
Biosimilar Pharmaceuticals
0
Adalimumab
FYS6T7F842
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
676-683Commentaires et corrections
Type : CommentIn