Secukinumab in patients with moderate-to-severe hidradenitis suppurativa based on prior biologic exposure: an efficacy and safety analysis from the SUNSHINE and SUNRISE phase III trials
- PMID: 38470171
- DOI: 10.1093/bjd/ljae098
Secukinumab in patients with moderate-to-severe hidradenitis suppurativa based on prior biologic exposure: an efficacy and safety analysis from the SUNSHINE and SUNRISE phase III trials
Abstract
Background: Hidradenitis suppurativa (HS) is a chronic inflammatory skin disease associated with a substantial disease burden. Secukinumab has previously been reported to have sustained efficacy with a favourable safety profile in patients with moderate-to-severe HS. It is unknown whether prior biologic exposure affects the efficacy and safety of secukinumab.
Objectives: To investigate the efficacy and safety of secukinumab in patients with moderate-to-severe HS based on prior exposure to -biologics.
Methods: This was an analysis of the SUNSHINE and SUNRISE phase III trials of secukinumab in patients with moderate-to-severe HS. Patients were randomized at baseline to receive secukinumab every 2 (SECQ2W) or 4 weeks (SECQ4W), or placebo for 16 weeks. After week 16, patients on the SECQ2W and SECQ4W schedules remained on the same treatment regimen, while patients randomized to placebo were switched to either SECQ2W or SECQ4W up to week 52. Assessments based on prior exposure to biologics included Hidradenitis Suppurativa Clinical Response (HiSCR), abscess and inflammatory nodule (AN) count, flare rates, HS-related pain [numerical rating scale 30 (NRS30)], 55% reduction in the International Hidradenitis Suppurativa Severity Score System (IHS4-55), Dermatology Life Quality Index, EuroQol-5D and safety.
Results: Overall, 1084 patients were randomized in the SUNSHINE and SUNRISE trials and included in this analysis; 255 (23.5%) were biologic-experienced [SECQ2W (n = 80); SECQ4W (n = 81); placebo (n = 94)] and 829 (76.5%) were biologic-naïve [SECQ2W (n = 281); SECQ4W (n = 279); placebo (n = 269)]. At week 16, responses were more efficacious for secukinumab than for placebo with regard to HiSCR in patients who were biologic-experienced {SECQ2W 37.0% [odds ratio (OR) 1.60, 95% confidence interval (CI) 0.83-3.08]; SECQ4W 38.8% [OR 1.67, 95% CI 0.86-3.22]; placebo 27.3%} and biologic-naïve [SECQ2W 45.6% (OR 1.64, 95% CI 1.15-2.33); SECQ4W 45.4% (OR 1.61, 95% CI 1.13-2.29); placebo 34.2%]. Similar results were observed for AN count, NRS30 and IHS4-55. The higher response seen at week 16 with secukinumab was sustained, with a trend toward improvement over time, through to week 52 in both subgroups. Additional efficacy was observed for quality-of-life assessments, and no differences in safety between subgroups were observed.
Conclusions: Regardless of prior biologic exposure, secukinumab was efficacious in improving the signs and symptoms of HS. This finding positions secukinumab as the first option in patients who are biologic-naïve, as well as in patients who have previously been treated with other biologic therapy, based on individual patient needs.
Plain language summary
Hidradenitis suppurativa (HS) is a chronic skin disease that causes painful boils. HS is common and affects about 0.4% of the world’s population. Treating the condition is difficult, but drugs called ‘biologics’ can help to improve the symptoms. For example, secukinumab is a biologic drug that has been shown to be effective and well-tolerated for the treatment of HS. In this analysis, we investigated whether previous treatment with biologics could affect the effectiveness and tolerability of secukinumab. This analysis included data from two identical clinical trials (called SUNSHINE and SUNRISE) that recruited adult patients with HS who had moderate-to-severe disease. In these trials, patients took secukinumab 300 mg every 2 weeks or every 4 weeks for 1 year, or a placebo for 4 months and then switched to secukinumab until 1 year. At regular intervals, the effectiveness and tolerability of secukinumab were examined and the results were compared between patients who had previously used another biologic and patients who had never used a biologic before. After 16 weeks, patients who took secukinumab had better results than the patients who took a placebo, independent of previous biologic use. Secukinumab was still effective and had improved results over 1 year of treatment in both subgroups. Regardless of whether patients had previously been taking another biologic, secukinumab was just as tolerable as placebo and there were no new safety risks. Our analysis shows that secukinumab is effective and tolerable, regardless of whether patients have previously used another biologic drug.
© The Author(s) 2024. Published by Oxford University Press on behalf of British Association of Dermatologists.
Conflict of interest statement
Conflicts of interest C.C.Z. reports consultancy/advisory boards disease-relevant honoraria from Boehringer Ingelheim, Incyte, InflaRx, Janssen, Novartis, Regeneron, Sanofi, UCB and Viatris; has received speaker fees from Almirall, Novartis and UCB; is President of the European Hidradenitis Suppurativa Foundation (EHSF) e.V., coordinator of the ALLOCATE Skin Group of the ERN-Skin, chair of the Acne/Rosacea/Hidradenitis Suppurativa Task Force group of the European Academy of Dermatology and Venerology (EADV), and Editor of EADV News. He is co-copyright holder of the International Hidradenitis Suppurativa Severity Score System (IHS4) on behalf of the EHSF e.V. His institution has received disease-relevant grants from Boehringer Ingelheim, InflaRx, Novartis and UCB for his participation as a clinical investigator. T.P. has received consulting fees from AbbVie, Almirall, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Galderma, Incyte, Janssen, LEO Pharma, Novartis, Pfizer, Sanofi Genzyme, Sun Pharma, UCB and Vyne. D.P. reports consultancy, investigator, advisory board or data safety monitoring board honoraria from Bickel Biotechnology, Biofrontera, BMS, Dermira, LEO Pharma, US Novartis Pharmaceuticals, Pfizer, Regeneron and Sanofi. D.P.’s institution has received grants/research funding for the role of investigator from Almirall, Amgen, AOBiome, Asana Biosciences, Bickel Biotechnology, Celgene, Dermira, Eli Lilly, LEO Pharma, Menlo Therapeutics, Novartis Pharmaceuticals, Novo Nordisk, Ortho Dermatologics, Pfizer and Regeneron. M.B.W. is an employee of and stockholder in Novartis Ireland Ltd. A.O. has been principal investigator in clinical trials sponsored by AbbVie, Alfasigma, Almirall, Amgen, Difa Cooper, Celgene, Eli Lilly, Galderma, Janssen, Laboratori Farmacologici Milanesi, LEO Pharma, Novartis, Pfizer, Pierre Fabre, Regeneron, Sanofi, UCB Pharma and Boehringer Ingelheim. A.O.’s institution has received disease-relevant grants from AbbVie, Alfasigma, Almirall, Amgen, Difa Cooper, Celgene, Eli Lilly, Galderma, Janssen, Laboratori Farmacologici Milanesi, LEO Pharma, Novartis, Pfizer, Pierre Fabre, Regeneron, Sanofi, UCB Pharma and Boehringer Ingelheim. A.O. has received speaker fees from AbbVie, UCB, LEO Pharma, Novartis, Pfizer and Eli Lilly. M.S.A. has been the principal investigator for clinical trials funded by Novartis, Arcutis Biotherapeutics, Galderma Laboratories, Eli Lilly, AbbVie, Pfizer, Concert Pharmaceuticals, Dermira, UCB, Incyte, Boehringer Ingelheim, Amgen, Evelo Sciences, LEO Pharma, Bristol Myers Squibb, Dice Therapeutics, Kiniksa Pharmaceuticals, Zai Lab, Sanofi and Bausch Health; and has been on advisory boards for Amgen, AbbVie, Sanofi, Novartis, Incyte, Boehringer Ingelheim, UCB, Arcutis, Bristol Myers Squibb and Bausch Health. X.L. is an employee of Novartis Pharma Co., Ltd. China. L.U., A.L.M., I.A. and I.L. are employees and stockholders of Novartis Pharma AG, Switzerland. S.R. is an employee and stockholder of Novartis Pharmaceuticals Corp., USA. P.M.-B. has received honoraria for acting as a consultant and/or as a speaker for Regeneron, Pfizer, Eli Lilly, AbbVie, Janssen, Novartis, LEO Pharma, Almirall, Sanofi, Viatris, L’Oréal, Organon, Cantabria Labs, Evelo Biosciences and CSL; and has been principal investigator in clinical trials supported by Pfizer, Biogen, Janssen, Amgen, AbbVie, Sanofi, and Novartis.
References
Publication types
MeSH terms
Substances
Grants and funding
LinkOut - more resources
Full Text Sources
Medical
