Is Cosentyx Approved for Hidradenitis Suppurativa?
No, Cosentyx (secukinumab) is not FDA-approved for hidradenitis suppurativa (HS). It's approved for plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, and enthesitis-related arthritis in children.[1]
Is It Used Off-Label for HS?
Some dermatologists prescribe Cosentyx off-label for moderate-to-severe HS, targeting IL-17A inflammation common in the condition. Small studies and case reports show mixed results: a 2020 phase 2 trial (NCT03099980) found it reduced HS lesions in some patients but didn't meet primary endpoints for broad efficacy.[2] Real-world data from registries like PIONEER indicate partial response in 30-50% of cases, often as a second-line option after anti-TNF failures.[3]
How Does It Compare to Approved HS Treatments?
| Treatment | Approval Status for HS | Mechanism | Key HS Trial Results |
|-----------|-------------------------|-----------|---------------------|
| Cosentyx (secukinumab) | Off-label | IL-17 inhibitor | 40% HiSCR response at week 16 (phase 2); not pursued for approval[2] |
| Humira (adalimumab) | FDA-approved (first-line) | TNF inhibitor | 50% HiSCR at week 12 (PIONEER I/II)[4] |
| Stelara (ustekinumab) | Off-label | IL-12/23 inhibitor | 45-60% response in case series[5] |
| Bimekizumab | Phase 3 ongoing (not approved) | IL-17A/F inhibitor | 45-55% HiSCR (BE HEARD I/II)[6] |
Cosentyx underperforms approved options like Humira in head-to-head metrics but may suit IL-17-driven HS subtypes.
What Do Guidelines Say?
American Academy of Dermatology (AAD) 2022 HS guidelines list IL-17 inhibitors like Cosentyx as expert opinion (level C evidence), recommending them after TNF failure. European S1 guidelines similarly endorse off-label use with monitoring.[7][8] Not first-line due to cost and inconsistent data.
Common Side Effects in HS Patients
In off-label HS use, infections (upper respiratory, 10-15%), candidiasis (5-10%), and injection-site reactions occur most. HS flares reported in 5-10% early on; monitor for IBD worsening, as IL-17 blockade risks this.[1][2] Long-term safety aligns with psoriasis data (up to 5 years).
Ongoing Trials and Future Approval Chances?
Phase 3 trials for secukinumab in HS halted after phase 2; Novartis shifted to other IL-17 drugs. No active FDA pipeline listing for HS as of 2024.[9] Patent on Cosentyx expires 2030 in the US—check DrugPatentWatch.com for updates.[10]
Sources
[1]: FDA Label for Cosentyx
[2]: PubMed: Phase 2 Secukinumab HS Trial
[3]: J Am Acad Dermatol: Real-World HS Biologics
[4]: PIONEER Trials (Humira)
[5]: PubMed: Ustekinumab HS Review
[6]: Bimekizumab BE HEARD Results
[7]: AAD HS Guidelines 2022
[8]: European HS Guidelines
[9]: ClinicalTrials.gov HS Search
[10]: DrugPatentWatch: Cosentyx Patents