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A 3-year retrospective cohort study examining the safety and efficacy of switching from an adalimumab originator to biosimilar has returned positive results supporting switching from adalimumab to a biosimilar in those with moderate-to-severe psoriasis.
With data from 100 patients who switched from adalimumab originator to a biosimilar, results of the study incite the maintenance or improvement in baseline Psoriasis Area and Severity Index (PASI) and Demonology Life Quality Index (DLQI) observed among those who remained on a biosimilar were both greater than 90%, with 19% of patients switching back to adalimumab.
“There are few studies that have assessed the tolerability and efficacy of switching from the adalimumab originator to a biosimilar in patients with well-controlled moderate-to-severe psoriasis,” wrote investigators. “Our objective was to describe the clinical experience of switching patients from the adalimumab originator to a biosimilar and that of switching back to the originator for those intolerant to biosimilars.”
With the advent of biosimilars promising to alleviate much of the cost incurred by patients with a slew of conditions, the medical community and patient advocates have looked forward to the future with optimism surrounding the potential impact of biosimilars. With this in mind, a trio of clinicians from the Department of Dermatology at St Vincent’s University Hospital in Ireland designed the current study with the intent of exploring the clinical experience of switching patients from the adalimumab originator to a biosimilar and of switching back to the originator for those intolerant to biosimilars.
A single-center, retrospective cohort study, investigators leveraged the British Association of Dermatologists Biologic Immunomodulators Register (BADBIR) and the National High Tech Prescribing Hub to identify patients with moderate-to-severe psoriasis who had switched from the adalimumab originator (Humira) to a biosimilar (Amgevita, Imraldi) from 2018 to 2022. Of note, investigators required patients to have received adalimumab biosimilar for a minimum of 16 weeks and no patients were included if they were being treated for an indication other than psoriasis.
Overall, investigators identified 100 patients who had switched from the adalimumab originator to a biosimilar. After 16 weeks, 81% of patients maintained their initial switch from the adalimumab originator to biosimilar, with 2% switching to a secondary biosimilar. The remaining 19% of patients switched back to the originator. Initial analyses indicated the patient demographics and treatment data were evenly distributed throughout both groups of patients.
Upon analysis, results indicated maintenance or improvement in baseline PASI and DLQI was observed among 91% and 90%, respectively, among those who remained on a biosimilar at 16 weeks. Among those considered intolerant to biosimilars maintenance or improvement in baseline PASI and DLQI were observed among 63% and 47%, respectively. When assessing adverse events leading to switching back to the adalimumab originator, cited reasons included discomfort with self-administration, disimprovement in psoriasis, disimprovement in joint symptoms, bruising at injections site, gastrointestinal upset, pruritus sinusitis, and noncompliance.
Investigators pointed out the switch back rate observed in their trial was more than double the rate observed in previous studies, but the overall rate was not dissimilar to studies conducted in other inflammatory conditions.
“Physicians should be confident in switching patients with well-controlled psoriasis to adalimumab biosimilars,” wrote investigators. “For the small proportion of patients who experienced loss of efficacy or adverse events, all were recaptured by either switching to an alternative adalimumab biosimilar or switching back to the adalimumab originator.”