Switching From Ustekinumab to Biosimilar SB17 Maintains Efficacy, Safety in Patients With Psoriasis

Biosimilar SB17 demonstrated clinical biosimilarity to reference ustekinumab after switching and maintained long-term comparable efficacy and safety up to week 52. | Image Credit: Егор Кулинич - stock.adobe.com

Patients with psoriasis who switched from reference ustekinumab to its biosimilar, SB17, experienced comparable long-term efficacy and safety, alleviating concerns about switching and promoting wider use of more affordable treatment options, according to a study published in the Journal of Dermatological Treatment.¹

Biologic treatments have improved efficacy and revolutionized the treatment landscape of psoriasis because they offer more affordable options to patients. The FDA reported generic and biosimilar medicines generated over $3 trillion in savings for patients and the health care system for the last 10 years.²

Concerns surrounding switching from originators to biosimilars are often based on fears that patients would experience adverse outcomes like diminished efficacy or increased hypersensitivity.¹ However, previous research found that the rates of serious adverse events, deaths, and treatment discontinuations among patients who switched between a biosimilar and a reference biologic were similar to those among patients who did not switch.³

Additional clinical evidence has shown that switching from an originator product to a biosimilar version is safe and effective long-term and that itdoes not lead to undesirable clinical outcomes.¹ Biosimilar SB17 is approved in both the US and Europe for patients with plaque psoriasis, psoriatic arthritis, and inflammatory bowel disease.

The phase 3, randomized double-blind, multicenter trial was conducted to assess the efficacy, safety, and immunogenicity of switching between SB17 and reference ustekinumab to determine if clinical biosimilarity remained up to week 52. There were 45 centers from 8 countries (Czech Republic, Estonia, Hungary, Republic of Korea, Lithuania, Latvia, Poland, and Ukraine) who participated during July 2021 to November 2022.

There were 503 participants as baseline who had a Psoriasis Area and Severity Index (PASI) greater than or equal to 12, a Physician’s Global Assessment of 3 or more, and a body surface area involvement of at least 10% at screening and randomization or more. At week 28, there were 481 participants who were rerandomized to either continue SB17 (SB17+SB17; n = 237), switch from ustekinumab to SB17 (UST+SB17; n = 122), or continue ustekinumab (UST+UST; n = 122).

Most of the participants (96.9%) completed the study up to week 52, with a balanced drop-out pattern (SB17+SB17, 1.7%; UST+SB17, 4.1%; UST+UST, 4.9%).

Across all treatment groups, the PASI from baseline up to week 52 was nearly identical, showing no signs of lack of efficacy. At week 52, the percent change of PASI was comparable between treatment groups (SB17+SB17, 95.8%; UST+SB17, 95.6%; UST+UST, 94.5%). The secondary efficacy endpoints from baseline to week 40 to week 52 were comparable across all 3 treatment groups.

Biosimilar SB17 and reference ustekinumab had similar safety profiles. The treatment emergent adverse events (TEAEs) were 16.5% for patients who continued SB17, 13.9% for patients who switched from ustekinumab to SB17, and 23.8% for patients who did not switch from the reference product. The most common TEAEs were COVID-19 and nasopharyngitis. There were no injection site reactions or systemic hypersensitivity found after switching between medications either.

The ongoing war in Ukraine posed a study limitation, disrupting some sites. However, these disruptions were evenly distributed across treatment groups, minimizing any potential bias.

These findings “may not prevent nocebo effects post-market, which may require additional efforts to mitigate” but“the lack of safety issues with ustekinumab switching to SB17 should be reassuring,” stated study authors.

References

1. Feldman SR, Narbutt J, Giampiero 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 DermatolTreat. 2024;35(1). doi:10.1080/09546634.2024.2436607
2. 2024 savings report. Association for Accessible Medicines. June 12, 2024. Accessed January 23, 2025. https://accessiblemeds.org/resources/blog/2024-savings-report/
3. Ferreri D. Analyzing safety of switching from originators to biosimilars: a meta-analysis of 21 trials. The Center for Biosimilars®. February 10, 2024. Accessed January 23, 2025. https://www.centerforbiosimilars.com/view/analyzing-safety-of-switching-from-originators-to-biosimilars-a-meta-analysis-of-21-trials