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Self-Administered Psoriasis Drug Shows Promise in Late-Stage Trial

Secukinumab delivers significant skin clearance at 12 weeks

Secukinumab (Novartis), a selective interleukin-17A (IL-17A) inhibitor, has met both co-primary endpoints at week 12 based on the Psoriasis Area and Severity Index (PASI) 75 and on the Investigator’s Global Assessment modified 2011 (IGA mod 2011) 0/1 response rates compared with placebo in two pivotal phase III trials.

The results from the FEATURE and JUNCTURE studies also demonstrated skin clearance at week 12 based on PASI 90 response rates compared with placebo; the usability and acceptability of the secukinumab prefilled syringe (PFS) and autoinjector pen; and an approximately 50% mean decrease in PASI scores from baseline by week 3 (300 mg) and week 4 (150 mg).

These results were presented at the 72nd Annual Meeting of the American Academy of Dermatology (AAD), held March 21–25 in Denver, Colorado.

The FEATURE (First Study of SEcukinumAb in Prefilled Syringes in SubjecTs With Chronic PlaqUe-Type Psoriasis REsponse) trial was a randomized double-blind, placebo-controlled, phase III study involving 177 subjects with moderate-to-severe plaque psoriasis. In this trial, the secukinumab PFS was introduced into the secukinumab clinical program.

The study’s co-primary endpoints were assessed at week 12 and compared the efficacy of secukinumab with that of placebo according to PASI 75 and the IGA mod 2011 0/1 response. Secondary endpoints included the PASI 90 response up to week 12 and patient satisfaction with self-injection of secukinumab via the PFS, as determined by a self-administered Self-Injection Assessment Questionnaire (SIAQ). The trial is ongoing.

The results from the FEATURE trial demonstrated the efficacy of secukinumab 300 mg and 150 mg based on a significantly higher proportion of patients who achieved a PASI 75 response at week 12 compared with patients given placebo: 75.9% (300 mg) and 69.5% (150 mg) versus 0% for placebo (P < 0.0001). On the co-primary endpoint, the efficacy of secukinumab 300 mg and 150 mg was demonstrated by a significantly higher proportion of patients who achieved an IGA mod 2011 0/1 response at week 12 compared with placebo: 69.0% (300 mg) and 52.5% (150 mg) versus 0% for placebo (P < 0.0001).

The JUNCTURE (Judging the Efficacy of SecUkinumab in Patients With Psoriasis Using AutoiNjector: A Clinical Trial EvalUating Treatment REsults) trial was a double-blind, placebo-controlled, multicenter, phase III study involving 182 subjects with moderate-to-severe plaque psoriasis. In this study, the autoinjector pen was introduced into the secukinumab clinical program.

The co-primary endpoints were PASI 75 and the IGA mod 2011 0/1 response for secukinumab compared with placebo at week 12. Secondary endpoints included the PASI 90 response up to week 12 and patient satisfaction with self-injection of secukinumab via the autoinjector pen, as determined by the SIAQ. The trial is ongoing.

Results from JUNCTURE also demonstrated the efficacy of secukinumab 300 mg and 150 mg based on a significantly higher proportion of patients who achieved a PASI 75 response at week 12 compared with those given placebo: 86.7% (300 mg) and 71.7% (150 mg) versus 3.3% for placebo (P < 0.0001). On the co-primary endpoint, the efficacy of secukinumab 300 mg and 150 mg was demonstrated based on a significantly higher proportion of patients who achieved an IGA mod 2011 0/1 response at week 12 compared with the placebo group: 73.3% (300 mg) and 53.3% (150 mg) versus 0% for placebo (P < 0.0001).

A secondary endpoint of both the FEATURE and JUNCTURE trials measured patient satisfaction with and the usability of self-injection of secukinumab via the PFS or the autoinjector pen, respectively. Satisfaction was assessed in both studies using SIAQ. Overall, patient-reported acceptability of both the PFS and the autoinjector pen were high at baseline across both studies and remained high during the study.

Secukinumab is a fully human monoclonal antibody that selectively targets interleukin (IL)-17A. The drug has been shown to selectively bind to and neutralize IL-17A, inhibiting its pro-inflammatory effects.

L-17A is a key cytokine (messenger protein) involved in the development of plaque psoriasis and is found in high concentrations in psoriasis skin plaques.

Source: Novartis; March 22, 2014.

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