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
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

676-683

Commentaires et corrections

Type : CommentIn

Auteurs

Nikolai Loft (N)

Department of Dermatology and Allergy, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.
Copenhagen Research Group for Inflammatory Skin, Herlev and Gentofte Hospital, Hellerup, Denmark.

Alexander Egeberg (A)

Department of Dermatology and Allergy, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.
Department of Dermatology, Bispebjerg Hospital, Copenhagen, Denmark.

Mads Kirchheiner Rasmussen (MK)

Department of Dermatology, Aarhus University Hospital, Aarhus, Denmark.

Lars Erik Bryld (LE)

Department of Dermatology, Zealand University Hospital, Roskilde, Denmark.

Christoffer Valdemar Nissen (CV)

Department of Dermatology, Bispebjerg Hospital, Copenhagen, Denmark.

Tomas Norman Dam (TN)

Dermatology Clinic, Nykoebing Falster, Denmark.

Kawa Khaled Ajgeiy (KK)

Department of Dermatology, Odense University Hospital, Odense, Denmark.

Lars Iversen (L)

Department of Dermatology, Aarhus University Hospital, Aarhus, Denmark.

Lone Skov (L)

Department of Dermatology and Allergy, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.
Copenhagen Research Group for Inflammatory Skin, Herlev and Gentofte Hospital, Hellerup, Denmark.

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