- Kimball A. LBA Secukinumab in moderate to severe hidradenitis suppurativa: Primary endpoint analysis from the SUNSHINE and SUNRISE Phase 3 trials. D3T01.1A, EADV Congress 2022, Milan, Italy, 7–10 September.
SUNSHINE (NCT03713619) and SUNRISE (NCT03713632) recruited over 1,000 patients worldwide with HS at 219 sites. “This is only the second phase 3 programme we have ever seen in HS and the first one since 2016, so it really is a milestone,” Prof. Alexandra Kimball (Harvard Medical School, MA, USA) highlighted. The 52-week studies assessed secukinumab after a loading phase administered at dosages of 300 mg every 2 (Q2W) or 4 weeks (Q4W) versus placebo, in adult patients with moderate-to-severe HS. Results of the primary endpoint at week 16, i.e. the proportion of patients achieving hidradenitis suppurativa clinical response (HiSCR), were revealed.
Although the study was conducted during the COVID-19 pandemic, over 90% of the randomised participants completed week 16. Overall, the mean age was 36.2 years, with a higher proportion of older patients in the Q2W arm of SUNRISE (42.8% between 40 and <65 years). Most participants were women and over 50% weighed 90 Kg or more. Hurley stage 2 and 3 proportions differed in SUNSHINE versus SUNRISE with 61.4% and 34.0% versus 56.7% and 40.5%, respectively.
In SUNSHINE, 45% in the Q2W arm achieved HiSCR versus 33.7% on placebo (P=0.0070), while the Q4W arm did not reach the predefined significance threshold. The SUNRISE participants of both treatment groups attained significant HiSCR results with 42.3% (Q2W; P=0.0149) and 46.1% (Q4W; P=0.0022) versus 31.2% on placebo. With regard to reduction of abscesses and nodules, the same treatment groups of the 2 studies demonstrated statistically significant results.
“The top line news here is fabulous: patients are getting better and both studies met their primary endpoint,” Prof. Kimball stressed. She furthermore accentuated that not only flaring decreased on the study drug, but also pain. Moreover, a clinically meaningful amelioration of quality-of-life was seen as early as week 2 in an exploratory analysis.
As for adverse events, the studies did not reveal unexpected results. “Very reassuring safety data, consistent with what we have seen before and a very clean profile overall,” Prof. Kimball stated. “We expect secukinumab to be a new, safe, and effective addition to our armamentarium in treating HS,” she concluded.