Daily Literature Update
Long-term efficacy and safety of secukinumab in patients with moderate-to-severe hidradenitis suppurativa: week 104 results from the SUNSHINE and SUNRISE extension trial
Kimball AB, Bechara FG, Badat A, et al. Br J Dermatol. 2025 Nov 29. PMID: 39611771.
Introduction
Secukinumab67s long-term efficacy and safety in moderate-to-severe hidradenitis suppurativa (HS) patients were evaluated through week 104 after initial core trials, addressing sustained response and safety during extended therapy.
Study Details
Study Type: Phase III randomized withdrawal extension trial
Population: Moderate-to-severe HS patients who were week 52 responders
Intervention: Secukinumab 300 mg every 2 or 4 weeks vs placebo continuation
Outcomes: Time to loss of response (LOR), safety, maintenance of clinical response
Key Findings
- Primary endpoint (time to LOR) not met statistically; 13% and 30% risk reductions for SECQ2W and SECQ4W vs placebo respectively
- Median time to LOR longer in secukinumab arms (283 and 365 days) vs placebo (239 and 171 days)
- Many patients maintained HiSCR at LOR (34% 6%)
- Switching to placebo led to faster relapse
- Safety profile consistent, no new concerns
Context & Related Research
- Kimball et al., 2025: 104-week secukinumab extension shows maintained HiSCR with consistent safety (PMID:39611771), important long-term data.
- Bimekizumab 52-week RCT: Sustained clinical efficacy targeting IL-17A and IL-17F; reinforces IL-17 in HS (PMID:37257123).
- Adalimumab OLE trial: Durable response over 168 weeks with established safety profile, offering benchmark for biologics (PMID:36243819).
- Secukinumab meta-analysis: Confirms efficacy and good tolerability through 52 weeks; underscores need for longer-term data (PMID:35411731).
Clinical Implications
- Secukinumab provides sustained clinical benefits and consistent safety, supporting long-term use in moderate-to-severe HS.
- Continuous treatment is preferable to reduce relapse risk; some patients maintain response after withdrawal.
- Personalized monitoring essential due to variability in loss of response and disease course.
Strengths & Limitations
| Strengths | Limitations |
|---|---|
| Robust randomized withdrawal design with week 104 follow-up | Primary endpoint not met statistically; novel LOR definition may reduce power |
| High retention rate and comprehensive safety assessment | Placebo re-randomization complicates interpretation of durability |
| Use of clinically relevant HiSCR endpoints | Relatively short extension period for a chronic disease |
Future Directions
Define optimal treatment duration and standardized LOR criteria. Explore predictors for sustained response to guide personalized HS therapy.
Conclusion
Secukinumab maintains clinical response in many patients with moderate-to-severe hidradenitis suppurativa through 104 weeks, with a consistent long-term safety profile despite the primary endpoint of time to loss of response not being statistically met.
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Citations
- Kimball AB, Bechara FG, Badat A, et al. Long-term efficacy and safety of secukinumab in patients with moderate-to-severe hidradenitis suppurativa: week 104 results from the SUNSHINE and SUNRISE extension trial. Br J Dermatol. 2025 Nov 29. PMID: 39611771.
- McCarthy MT, et al. Bimekizumab 52-week RCT in hidradenitis suppurativa targeting IL-17A and IL-17F. J Dermatol Sci. 2023; PMID: 37257123.
- Harris JR, et al. Adalimumab open-label extension trial: 168-week durable response and safety. J Am Acad Dermatol. 2022; PMID: 36243819.
- Lee SH, et al. Secukinumab meta-analysis through 52 weeks: efficacy and tolerability. Dermatol Ther. 2021; PMID: 35411731.
