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Safety and efficacy of adalimumab interchangeability with CT-P17 adalimumab biosimilar: Results from the OLE of a phase III study
Use of biosimilars can potentially allow for a greater number of patients to receive treatment. However, it is necessary to assess whether biosimilars offer the same safety and efficacy as the reference therapy. A phase III, randomized, multicenter trial (NCT05495568) assessed pharmacokinetics, efficacy, safety, and immunogenicity of CT-P17 (adalimumab biosimilar) following repeated switching with reference adalimumab in patients with moderate-to-severe chronic plaque psoriasis over a 27-week period. All patients received reference adalimumab for 11 weeks, and at Week 13 they were randomized to continue with reference adalimumab or to undergo repeated switching between reference and the biosimilar. After 27 weeks of switching or continuous reference adalimumab, all patients could enter an OLE and receive CT-P17 biweekly for an additional 22 weeks. In total, 327 patients entered the OLE, with results published in Dermatology and Therapy by Pariser et al.
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Key learnings |
Mean serum concentrations of adalimumab remained stable and similar in the OLE between patients who had undergone previous switching and those on continuous treatment, with no clinically meaningful difference. |
Clinical benefits were maintained through Week 52, with no loss of response following multiple switches. PASI 75/90/100 responses were similar across groups, with 66.3% and 64.7% of patients in the switching and continuous groups achieving PASI 90, respectively. |
No new safety signals emerged. TEAEs were similar between groups and consistent with the known adalimumab safety profile. Discontinuation due to TEAEs occurred in 2 patients in each treatment group. |
Pharmacokinetics, efficacy, and safety findings remained consistent throughout the OLE, irrespective of previous treatment, and were generally similar across timepoints. The results of this OLE provide further support for the interchangeability of CT-P17 and reference adalimumab. |
Abbreviations: PASI 75/90/100, 75%/90%/100% improvement in Psoriasis Area and Severity Index; OLE, open-label extension; TEAE, treatment-emergent adverse event.
References
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