Secukinumab (Cosentyx®)
Drug class: Interleukin-17A antagonist (1)
Mechanism of Action
Secukinumab is a targeted biologic therapy designed to interrupt key pathways in inflammatory diseases. It works by binding to interleukin 17A (IL 17A), a cytokine central to the inflammatory process. By blocking IL 17A from interacting with its receptor on keratinocytes and other cell types, secukinumab neutralizes this signaling pathway. This inhibition reduces the downstream inflammatory cascade that drives plaque psoriasis, psoriatic arthritis, and axial spondyloarthritis (2).
Approved Indications
Plaque psoriasis (PsO): Adults and pediatric patients ≥6 years (1)
Psoriatic arthritis (PsA): Adults and pediatric patients ≥2 years (1)
Ankylosing spondylitis (AS): Adults and pediatric patients ≥12 years (1)
Non-radiographic axial spondyloarthritis (nr-axSpA): Adults with objective inflammation (1)
Enthesitis-related arthritis (ERA): Pediatric patients ≥4 years(1)
Hidradenitis suppurativa (HS): Adults and pediatric patients ≥12 years (1)
Dosage and Administration
PsO: 300 mg SC at Weeks 0–4, then q4w (1)
PsA: 150 mg SC at Weeks 0–4, then q4w; 300 mg q4w if persistent active disease. Use PsO dosing with moderate–severe PsO (1)
AS/nr-axSpA: 150 mg SC at Weeks 0–4, then q4w; consider 300 mg q4w for persistent active AS (1)
HS: 300 mg SC at Weeks 0–4, then q4w; q2w if inadequate response (1)
Pediatrics: Weight-based dosing; IV option for selected adult indications (1)
Key clinical benefits
Produces rapid and sustained improvement in psoriasis severity and skin clearance (1)
Improves joint signs and symptoms and inhibits radiographic progression in PsA (1)
Improves symptoms and physical function in AS and nr-axSpA (1)
Provides sustained clinical response in HS (1)
Key clinical trials
Secukinumab Phase 3 Trials in Plaque Psoriasis
Two randomized Phase 3 trials, ERASURE and FIXTURE, evaluated secukinumab in patients with moderate to severe plaque psoriasis (3).
ERASURE Trial
Around 738 patients were enrolled in this study. At Week 12, PASI 75 was achieved by 81.6% of patients receiving secukinumab 300 mg and 71.6% with 150 mg, compared with only 4.5% in the placebo group (3).
FIXTURE Trial
Around 1,306 patients were enrolled in this study. At Week 12, PASI 75 response rates were 77.1% with secukinumab 300 mg and 67.0% with 150 mg, versus 44.0% with etanercept and 4.9% with placebo. These results demonstrated greater efficacy with secukinumab. (3)
FUTURE 2 Trial – Secukinumab in Psoriatic Arthritis
In the Phase 3 FUTURE 2 trial, investigators evaluated secukinumab in 397 patients with active psoriatic arthritis, randomized to receive subcutaneous doses of 300 mg, 150 mg, 75 mg, or placebo. At Week 104, ACR20 response rates were 69.4% with 300 mg, 64.4% with 150 mg, and 50.3% with 75 mg. Clinical improvements across multiple psoriatic arthritis domains were sustained through two years, including in patients who had previously received anti‑TNF‑α therapy (4).
MEASURE 1 and MEASURE 2 Trials – Secukinumab in Ankylosing Spondylitis
In the Phase 3 MEASURE 1 and MEASURE 2 trials, investigators evaluated secukinumab in patients with active ankylosing spondylitis, enrolling 371 and 219 patients, respectively. At Week 16, ASAS20 response rates with secukinumab 150 mg were 61% in both trials, compared with 29% in MEASURE 1 and 28% in MEASURE 2 for placebo. These findings demonstrated significant improvement in AS symptoms with secukinumab treatment (5).
PREVENT Trial – Secukinumab in Non-Radiographic Axial Spondyloarthritis (nr axSpA)
The Phase 3 PREVENT trial randomized 555 patients with active nr axSpA to receive secukinumab 150 mg subcutaneously, with or without a loading dose, or placebo. At Week 16, ASAS40 response was highest in the CRP+/MRI+ subgroup, with 52.3% of patients responding to secukinumab compared with 21.8% on placebo (P<0.0001). Response rates were also higher with secukinumab across key subgroups, including HLA B27+ (43.9% vs 32.6%), HLA B27− (32.7% vs 16.4%), male (51.2% vs 30.8%), and female (31.7% vs 25.3%). Overall, secukinumab improved the signs and symptoms of nr axSpA consistently across CRP, MRI, HLA B27, and sex subgroups (6).
SUNSHINE and SUNRISE Trials – Secukinumab in Hidradenitis Suppurativa (HS)
The identical Phase 3 SUNSHINE and SUNRISE trials evaluated secukinumab 300 mg subcutaneously every 2 weeks (q2w) or every 4 weeks (q4w) versus placebo in patients with moderate to severe hidradenitis suppurativa, enrolling 541 patients in SUNSHINE and 543 in SUNRISE. At Week 16, HS clinical response (HiSCR) was achieved by 45% of patients receiving secukinumab q2w compared with 34% on placebo in SUNSHINE. In SUNRISE, HiSCR rates were 42% with q2w and 46% with q4w, versus 31% with placebo. Responses were sustained through Week 52, with no new or unexpected safety findings reported (7).
Common Adverse Events
Nasopharyngitis (1)
Diarrhea (1)
Upper respiratory tract infection (1)
Headache (1)
Injection-site reactions (1)
Mucocutaneous candidiasis (1)
Contraindications / Precautions
Serious hypersensitivity to secukinumab or its components (1)
Increased risk of infections; evaluate patients for TB before initiation (1)
Use caution in patients with inflammatory bowel disease (1)
Avoid live vaccines during treatment (1)
Monitor for hypersensitivity/anaphylaxis and severe eczematous eruptions (1)
Special Notes for Clinician
Complete age-appropriate vaccinations and evaluate for TB before initiating therapy (1)
Avoid treatment during active serious infection; discontinue if a serious infection develops (1)
Monitor patients with a history of or risk for IBD (1)
Do not administer live vaccines during treatment (1)
Abbreviations
ACR: American College of Rheumatology; AS: ankylosing spondylitis; ASAS: Assessment of SpondyloArthritis international Society; CRP: C-reactive protein; HLA-B27: human leukocyte antigen B27; HS: hidradenitis suppurativa; IL-17A: interleukin-17A; LD: loading dose; MRI: magnetic resonance imaging; nr-axSpA: non-radiographic axial spondyloarthritis; PASI: Psoriasis Area and Severity Index; PsA: psoriatic arthritis; PsO: plaque psoriasis; SC: subcutaneous; TB: tuberculosis.
References
U.S. Food and Drug Administration. COSENTYX® (secukinumab) Prescribing Information. Revised April 2026.
Godse K. Secukinumab - First in Class Interleukin-17A Inhibitor for the Treatment of Psoriasis. Indian J Dermatol. 2017;62(2):195-199.
Langley RG, et al. Secukinumab in Plaque Psoriasis—Results of Two Phase 3 Trials. N Engl J Med. 2014;371:326–338.
McInnes IB, et al. Secukinumab, a Human Anti-IL-17A Monoclonal Antibody, in Patients with Psoriatic Arthritis (FUTURE 2). Lancet. 2015;386:1137–1146.
Baeten D, et al. Secukinumab in Patients with Ankylosing Spondylitis. N Engl J Med. 2015;373:2534–2548.
Deodhar A, et al. Secukinumab in Non-Radiographic Axial Spondyloarthritis (PREVENT). Arthritis Rheumatol. 2021;73:1108–1118.
Kimball AB, et al. Secukinumab in Moderate-to-Severe Hidradenitis Suppurativa (SUNSHINE and SUNRISE). Lancet. 2023;401:747–761.
About the Author
Dr. Sheeba Rani is a Pharm.D graduate currently working as a medical writer, with growing expertise in medical data annotation. Passionate about clinical research and medical writing, she has a keen interest in exploring novel pharmacotherapeutic agents and leveraging data annotation techniques to advance patient care and healthcare innovation. Beyond her professional pursuits, Dr. Sheeba enjoys cooking and spending time outdoors, finding balance between science, creativity, and wellness.
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