What is the effectiveness and safety of biosimilars compared with originator biologics for the treatment of patients with psoriasis?
This systematic review of 14 randomized clinical trials and 3 cohort studies found that there was no clinically or statistically significant difference in efficacy and safety between biosimilars of adalimumab, etanercept, infliximab, ustekinumab, and originators for the treatment of patients with psoriasis. Overall, findings from 2 randomized clinical trials suggested that switching from adalimumab originator to BCD-057 and GP2017 reduced treatment efficacy, and 1 cohort study suggested that switching to GP2017 and SB5 was associated with more adverse effects; however, these differences were not clinically significant, and the certainty of evidence was low.
Starting new patients on biosimilars or switching patients recieving originators to biosimilars could be considered to reduce treatment costs; future studies are needed to examine the long-term effectiveness and safety of biosimilars in clinical settings.
Biosimilars have the potential to reduce costs for the management of moderate-to-severe psoriasis compared with originators. However, the extrapolation of evidence enables the approval of a biosimilar for use in indications held by the originator without directly being studied in clinical trials. Thus, biosimilars can be approved for psoriasis based on extrapolated evidence from other diseases. The availability of evidence for the effectiveness and safety of biosimilars for the treatment of psoriasis is therefore unclear.
To compare the efficacy/effectiveness and safety of biosimilars with originator biologics for the treatment of patients with psoriasis.
MEDLINE, EMBASE, Cochrane Library, ClinicalTrials.gov, and The European Union Clinical Trials Register were searched in August 2022. Eligible studies were appraised using the Cochrane Risk of Bias 2 and ROBINS-I tools. All analyses were conducted from September 2022 to November 2022.
Fourteen trials (10 adalimumab, 2 etanercept, 1 infliximab, and 1 ustekinumab) and 3 cohort studies (1 adalimumab, 1 etanercept, 1 infliximab and etanercept) were included. Twelve trials compared biosimilars with originators in originator-naive patients (starters), and 11 trials compared switching from originator to biosimilar (switchers) with continuous originator treatments. There was no clinically or statistically significant difference in rates of achieving 75% improvement in Psoriasis Area and Severity Index scores and risks of adverse events (AEs) at week 16 and week 52 between the comparators. Two cohort studies showed no difference in effectiveness and safety outcomes between originators and biosimilars, whereas 1 study reported more AEs in patients who switched to biosimilars of adalimumab at 12 months. Three trials showed low risk of bias, whereas 11 trials had moderate risk of bias. All cohort studies had moderate to high risk of bias.
Conclusions and Relevance
In this systematic review, there was no clinically or statistically significant difference in the efficacy and safety between biosimilars and originators for the treatment of patients with psoriasis. Most of the available evidence was based on randomized clinical trials, although high-quality real-world evidence was lacking. Future studies are needed to examine the long-term effectiveness and safety of biosimilars for the treatment of patients with psoriasis.
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Accepted for Publication: April 4, 2023.
Published Online: May 31, 2023. doi:10.1001/jamadermatol.2023.1338
Corresponding Author: Zenas Z. N. Yiu, MBChB, PhD, Dermatopharmacology Unit, Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust, Stott Lane, Barnes Building, Salford, M6 8HD, United Kingdom (email@example.com).
Author Contributions: Drs Yiu and Phan had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Phan, Warren, Yiu.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: Phan.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Phan.
Obtained funding: Warren, Yiu.
Administrative, technical, or material support: Phan, Elyoussfi, Stevenson.
Supervision: Lunt, Yiu.
Conflict of Interest Disclosures: Dr Warren reported grants from AbbVie, Almirall, Amgen, Celgene, Janssen, Lilly, Leo, Novartis, Pfizer, and UCB during the conduct of the study; personal fees from AbbVie, Almirall, Amgen, Arena, Astellas, Avillion, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, DiCE, GSK, Janssen, Lilly, Leo, Novartis, Pfizer, Sanofi, Sun Pharma, UCB, and UNION Therapeutics outside the submitted work. No other disclosures were reported.
Funding/Support: This research was funded by the Psoriasis Association and supported by the NIHR Manchester Biomedical Research Centre (NIHR203308).
Role of the Funder/Sponsor: The Psoriasis Association and the NIHR Manchester Biomedical Research Centre had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Meeting Presentation: An abstract of the study has been sent and accepted for a Poster presentation at the AAD 2023–American Academy of Dermatology Annual Meeting, New Orleans, Louisiana; March 17-21, 2023.
Additional Contributions: The authors acknowledge the substantial contribution of the participants in our online survey who provided their opinions. We acknowledge all members of the patient focus group for sharing their experiences and time.
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