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Improving outcomes for people of color with chronic plaque psoriasis including scalp involvement
with Paolo Gisondi, Andrew Alexis, and Mona Shahriari
Thursday, February 6, 2025
16:00-17:00 GMT
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Phase III trial: Biosimilar SB17 vs ustekinumab in moderate to severe plaque psoriasis
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Biosimilars provide similar efficacy and safety to their originator biologics.1 However, the consequences of switching from an originator to its corresponding biosimilar remain to be determined. Feldman et al.1 published in the Journal of Dermatological Treatment phase III trial (NCT04967508) results comparing the efficacy and safety of UST biosimilar SB17 to UST for the treatment of moderate to severe plaque psoriasis. A total of 503 patients were randomized to receive either SB17 or UST. At Week 28 patients receiving UST were re-randomized to receive either SB17 or continue UST.1 |
| Key learnings |
| The percent change of PASI from baseline to Wk52 was 95.8%, 95.6%, and 94.5% in the SB17 + SB17, UST + SB17, and UST + UST groups, respectively. At Wk52, secondary efficacy endpoints were comparable across groups. |
| The incidence of TEAEs was also comparable across groups: 16.5% in SB17 + SB17, 13.9% in UST + SB17, and 23.8% in the UST + UST group. |
| The incidence of ADA was 5.6%, 5.1%, and 6.7% in the SB17 + SB17, UST + SB17, and UST + UST groups, respectively. |
| Overall, the findings show that SB17 had comparable long-term efficacy, safety, and immunogenicity to UST after switching from UST. |
Abbreviations: ADA, anti-drug antibodies; PASI, Psoriasis Area and Severity Index; SB17, biosimilar to ustekinumab; TEAE, treatment-emergent adverse event; UST, ustekinumab; Wk, week.
- Feldman SR, Narbutt J, Girolomoni G, et al. Biosimilar SB17 versus reference ustekinumab in moderate to severe plaque psoriasis after switching: Phase 3 study results up to week 52. J Dermatolog Treat. 2024;35(1):2436607. DOI: 10.1080/09546634.2024.2436607
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