Novartis has released late-breaking data from an extension study of two Phase 3 clinical trials evaluating Cosentyx (secukinumab) to treat moderate-to-severe plaque psoriasis. The data supported the efficacy of the treatment in the long-term, through four years.
Other clinical trial results — also presented at the recent 25th European Academy of Dermatology and Venereology (EADV) Congress in Vienna — demonstrated the efficacy of Cosentyx against placebo in treating patients with moderate-to-severe palmoplantar plaque psoriasis and scalp psoriasis.
Cosentyx is a fully human monoclonal antibody (mAB) that selectively binds to the interleukin-17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor.
The extension study (NCT01640951) of the Phase 3 SCULPTURE (NCT01406938) and STATURE (NCT01412944 ) trials is evaluating the treatment’s safety, efficacy and tolerability in a total 642 patients who had completed 52 weeks of treatment in those earlier studied. Treatment success is measured using the Psoriasis Area Severity Index (PASI) response. Patients were given the same doses as in the core studies, in a refilled syringe liquid formulation: 300 mg of Cosentyx every four weeks (168 people) or 150 mg of Cosentyx every four weeks (152 people), or re-treatment on a as-needed basis (172 patients at 300 mg, and 150 at 150 mg).
Results presented at the congress covered SCULPTURE extension patients at the four-year treatment mark (the study remained blinded up to year three, and switched to open-label in year four), and showed:
- Completely clear skin (PASI 100) was achieved by 43.8% of patients at the end of the first year and by 41.7% of patients at the end of the third year, with 43.5% of patients maintaining results by the end of the fourth year.
- Almost clear skin (PASI 90) was achieved by 68.5% of patients at the end of the first year (week 52), by 61.9% of patients at the end of the third year (week 156), and by 66.4% of patients at the end of the fourth year (week 208).
- The standard goal of treatment (PASI 75) was achieved by 88.9% of patients at the end of the first year, and by 78.4% of patients at the end of the third year, with 88.5% maintaining results at the end of the fourth year.
Most common side effects reported at year four included nasopharyngitis (12.1%) and upper respiratory tract infection (3.5%), and were similar to those observed during the first year of treatment.
“These impressive results show that Cosentyx keeps working year-on-year, maintaining high levels of skin clearance with a favorable safety profile,” Vasant Narasimhan, Novartis’ global head of drug development and chief medical officer, said in a press release. “Psoriasis patients need therapies they can use over long periods of time without loss of efficacy and we are pleased that Cosentyx is proving a sustainable choice for patients.”
Other presentations covered results from the GESTURE study (NCT01806597), a double-blind, placebo-controlled trial to evaluate the efficacy and safety of Cosentyx in 205 patients with moderate-to-severe palmoplantar plaque psoriasis. All were randomized to receive either Cosentyx 300 mg, Cosentyx 150 mg, or placebo at weeks 0, 1, 2, 3 and 4, and then every four weeks.
Its primary endpoint was the proportion achieving palmoplantar Investigator’s Global Assessment (ppIGA) 0/1 (clear/almost clear) response at week 16. Results found that 40% of patients treated with Cosentyx 300 mg every four weeks reached this score, and by week 80, approximately 60% of patients achieved clear or almost clear palms and soles. Adverse events at week 80 were reported in 47 of the 69 patients receiving Cosentyx at 300 mg, and 27 of the 68 patients on placebo.
“[T]he palms and soles of the feet are generally very difficult to treat,” said Craig Leonardi, MD, an adjunct professor of dermatology at St. Louis University Medical School and author of a study on this trial. “This new data is significant as there is still high unmet need for effective treatments for those living with palmoplantar psoriasis.”
A third presentation discussed the results from the double-blind and placebo-controlled SCALP Phase 3 study (NCT02267135), evaluating the efficacy and safety of Cosentyx in 102 patients with moderate-to-severe scalp psoriasis.
Patients here were equally randomized to receive either subcutaneous Cosentyx 300 mg or placebo at weeks 0, 1, 2, 3 and 4, and then every four weeks for a total of 12 weeks. The primary endpoint was the proportion of patients achieving Psoriasis Scalp Severity Index (PSSI) 90 response rate at week 12 — a score achieved by 52.9% of patients on 300 mg treatment compared to 2.0% on placebo. Adverse events were reported in 52.9% of patients on that treatment and 49.0% of patients receiving placebo at week 12. No serious effects were reported with Cosentyx.