Analysis shows that moderate-to-severe psoriasis patients treated with Cosentyx (secukinumab) rapidly regain clear or almost clear skin following relapse during a treatment pause,- Novartis

Novartis announced a new analysis showing that moderate-to-severe psoriasis patients treated with Cosentyx (secukinumab) rapidly regain clear or almost clear skin (Psoriasis Area Severity Index, PASI 90 to 100) following relapse during a treatment pause. The analysis also showed no anti-secukinumab antibodies were observed during retreatment. These findings were presented at the 2017 American Academy of Dermatology (AAD) Annual Meeting in Orlando, Florida, at which Novartis presented over 35 scientific abstracts.

Previous data has shown favorable results for continuous over intermittent treatment, however sometimes patients have treatment pauses. This new analysis shows that if psoriasis patients relapse during treatment pauses, the majority can achieve previous high levels of efficacy after only 16 weeks of retreatment with Cosentyx. Immunogenicity is a frequent issue with many biologic psoriasis treatments that lose long-term efficacy over time. Cosentyx has previously demonstrated almost zero immunogenicity. Cosentyx is a fully human, targeted treatment that specifically inhibits the IL-17A cytokine and previous data has shown that it delivers high and long-lasting clear or almost clear skin in up to 80% of patients.

For patients who achieved PASI 75 responses after one year of treatment with Cosentyx (300mg), and then relapsed after treatment discontinuation (n=136), the analysis shows that, by Week 16 of retreatment with Cosentyx, 94% of patients regained a PASI 75 score, 79% of prior PASI 90 responders (n=117) regained a PASI 90 score and 67% of prior PASI 100 response (n=67) regained a PASI 100 score. In addition, the safety profile was favorable and consistent with that demonstrated in previous studies. Furthermore, no patients in this analysis were found to have developed anti-secukinumab antibodies.

An uncontrolled, extension study of ERASURE (Efficacy of Response and Safety of Two Fixed Secukinumab Regimens in Psoriasis), which compared Cosentyx with placebo, and FIXTURE (Full Year Investigative Examination of Secukinumab vs. Etanercept Using Two Dosing Regimens to Determine Efficacy in Psoriasis), which compared Cosentyx with placebo and etanercept. 181 subjects who achieved a PASI 75 response at the end of the core study (Week 52) were randomized to receive either Cosentyx 150mg, Cosentyx 300mg or placebo every four weeks to Week 104. Subjects in the placebo arm who relapsed were retreated with Cosentyx.

Comment:The use of biological therapies for psoriasis has been associated with the production of antidrug antibodies (ADAs) that may impact on treatment efficacy. Data shows that Cosentyx has almost zero immunogenicity, with only 11 of the 2,842 subjects (0.4%) showing ADAs.