TY - JOUR

T1 - Outcomes following a Mandatory Nonmedical Switch from Adalimumab Originator to Adalimumab Biosimilars in Patients with Psoriasis

AU - Loft, Nikolai

AU - Egeberg, Alexander

AU - Rasmussen, Mads Kirchheiner

AU - Bryld, Lars Erik

AU - Nissen, Christoffer Valdemar

AU - Dam, Tomas Norman

AU - Ajgeiy, Kawa Khaled

AU - Iversen, Lars

AU - Skov, Lone

N1 - Funding Information: receiving personal fees from Eli Lilly and Janssen outside the submitted work. Dr Egeberg reported receiving research funding from Pfizer, Eli Lilly, Novartis, Bristol-Myers Squibb, AbbVie, Janssen Pharmaceuticals, the Danish National Psoriasis Foundation, the Simon Spies Foundation, and the Kgl Hofbundtmager Aage Bang Foundation and honoraria as a consultant and/or speaker from AbbVie, Almirall, Leo Pharma, Galápagos NV, Sun Pharmaceuticals, Samsung Bioepis Co Ltd, Pfizer, Eli Lilly and Company, Novartis, Galderma, Dermavant, UCB, Mylan, Bristol-Myers Squibb, and Janssen Pharmaceuticals. Dr Rasmussen reported serving on the advisory board for Abbvie and UCB, receiving clinical trial support from UCB and Novartis, and serving as a consultant for Leo Pharmacies, Janssen, and Novartis outside the submitted work. Dr Nissen reported serving on the advisory board for Almirall outside the submitted work. Dr Iversen reported receiving personal fees from AbbVie, Novartis, Leo Pharmacies, Eli Lilly, Janssen Cilag, Almirall, and Samsung and grants from Regranion outside the submitted work. Dr Skov reported receiving speaker fees from AbbVie, Eli Lilly, Novartis, and Leo Pharmacies, consulting fees from AbbVie, Janssen Cilag, Novartis, Eli Lilly, Leo Pharmacies, UCB, Almirall, Bristol-Myers Squibb, and Sanofi, investigator fees from AbbVie, Sanofi, Janssen Cilag, Boehringer Ingelheim, AstraZeneca, Eli Lilly, Novartis, Regeneron, and Leo Pharmacies, and grants from Novartis, Sanofi, Bristol-Myers Squibb, Janssen Cilag, and Leo Pharmacies outside the submitted work. No other disclosures were reported. Publisher Copyright: © 2021 American Medical Association. All rights reserved.

PY - 2021

Y1 - 2021

N2 - Importance: 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. Objective: To assess the outcomes following a mandatory nonmedical switch from adalimumab originator to adalimumab biosimilars in patients with psoriasis. Design, Setting, and Participants: 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. Exposure: Switch from adalimumab originator to an adalimumab biosimilar. Main Outcomes and Measures: 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. Results: 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. Conclusions and Relevance: In this cohort study from Denmark, a nonmedical switch from adalimumab originator to adalimumab biosimilars was not associated with drug retention..

AB - Importance: 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. Objective: To assess the outcomes following a mandatory nonmedical switch from adalimumab originator to adalimumab biosimilars in patients with psoriasis. Design, Setting, and Participants: 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. Exposure: Switch from adalimumab originator to an adalimumab biosimilar. Main Outcomes and Measures: 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. Results: 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. Conclusions and Relevance: In this cohort study from Denmark, a nonmedical switch from adalimumab originator to adalimumab biosimilars was not associated with drug retention..

U2 - 10.1001/jamadermatol.2021.0221

DO - 10.1001/jamadermatol.2021.0221

M3 - Journal article

C2 - 33825804

AN - SCOPUS:85104025422

VL - 157

SP - 676

EP - 683

JO - JAMA Dermatology

JF - JAMA Dermatology

SN - 2168-6068

IS - 6

ER -