This is the first time a biologic demonstrated long-term efficacy and safety in nail and palmoplantar psoriasis.
Novartis has released first-of-its-kind long-term data indicating that secukinumab (Cosentyx) demonstrated sustained improvements in nail and palmoplantar psoriasis out to 2.5 years.
This is the first time any biologic has demonstrated long-term efficacy and safety in nail and palmoplantar psoriasis.
“Reduced mobility, functional impairment and physical discomfort are substantial issues faced daily by the up to 90% of psoriasis patients who may develop nail or palmoplantar psoriasis,” Eric Hughes, head global development unit, immunology and dermatology, Novartis, told MD Magazine. “For healthcare professionals, knowing that Cosentyx provides long-term efficacy and safety in treating plaque psoriasis, scalp psoriasis as well as nail and palmoplantar psoriasis, is of great significance given the debilitating and chronic nature of this disease. These unique data add to the growing body of evidence demonstrating the effectiveness of Cosentyx’ targeted mode of action which inhibits IL-17A, cornerstone cytokine involved in the development of psoriasis, psoriatic arthritis and ankylosing spondylitis.”
In GESTURE, the largest and longest duration randomized, placebo-controlled trial, investigated the safety and efficacy of Cosentyx 150 mg and 300 mg subcutaneous on 205 patients with moderate-to-severe palmoplantar psoriasis.
The results demonstrated that 59% and 53% of patients who received Cosentyx 300 mg and 150 mg, respectively, achieved clear or almost clear palms and soles at 2.5 years.
The effect of the treatment on palm and sole skin clearance was determined using the Palmoplantar Investigator’s Global Assessment (pplGA) and Palmoplantar Psoriasis Area and Severity Index (ppPASI). Consistent benefits were seen in changes in the ppPASI score.
A positive impact on quality of life was assessed via the Dermatology Life Quality Index (DLQI) and palmoplantar Quality of Life Instrument (pplQLI) scores.
In the TRANSFIGURE study, the first large, phase 3b study, measured the long-term safety and efficacy of Cosentyx 300 mg and 150 mg in moderate-to-severe nail psoriasis versus placebo on 198 participants.
The clinical effect was assessed at 2.5 years using the Nail Psoriasis Severity Index (NAPSI) and PASI.
Patients with moderate-to-severe nail psoriasis who were treated with Cosentyx showed a substantial Nail Psoriasis Severity Index (NAPSI) improvement from baseline. The impact on quality of life was measured using the Nail Assessment in Psoriasis and Psoriatic Arthritis (NAPPA) and EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D).
Sustained improvements in the NAPPA and EQ-5D scores highlighted the quality of life benefits received from treatment of patients reporting decreased pain and discomfort.
Both the GESTURE and TRANSFIGURE studies demonstrated strong sustainability out to 2.5 years, with a favorable and consistent safety profile that included close to 0 injection site reactions or associated pain.
The safety profile of Cosentyx was shown to be consistent with that seen in other clinical trials conducted across multiple indications.
“Patients with nail and palmoplantar psoriasis need effective treatment options to address the significant impact these conditions can have on their day-to-day lives,” said Hughes. “As an IL-17A inhibitor, Cosentyx provides a highly targeted treatment option that can not only effectively treat the plaques caused by psoriasis, as evident by recently presented 5-year data, but also hard-to-treat forms and associated arthritic conditions.”
Cosentyx addresses the cornerstone cytokine interleukin-17A (IL-17A) involved in the development and progression of psoriasis. It’s the first and only fully human IL-17A inhibitor that shows sustained skin clearance rates at 5 years and is approved to treat psoriasis, psoriatic arthritis, ankylosing spondylitis, palmoplantar psoriasis, nail psoriasis and scalp psoriasis. The targeted treatment specifically inhibits the IL-17A cytokine which plays a significant role in the pathogenesis.
Cosentyx delivers patients long-lasting skin clearance with proven sustainability safety out to 5 years through a convenient once-monthly dosing in a patient-friendly autoinjector.
A press release has been made available.