Outcomes following a Mandatory Nonmedical Switch from Adalimumab Originator to Adalimumab Biosimilars in Patients with Psoriasis
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Outcomes following a Mandatory Nonmedical Switch from Adalimumab Originator to Adalimumab Biosimilars in Patients with Psoriasis. / Loft, Nikolai; Egeberg, Alexander; Rasmussen, Mads Kirchheiner; Bryld, Lars Erik; Nissen, Christoffer Valdemar; Dam, Tomas Norman; Ajgeiy, Kawa Khaled; Iversen, Lars; Skov, Lone.
In: JAMA Dermatology, Vol. 157, No. 6, 2021, p. 676-683.Research output: Contribution to journal › Journal article › Research › peer-review
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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 -
ID: 301698593