Secukinumab clears skin in psoriasis patients: Studies

Psoriasis patients treated with interleukin-17A (IL-17A) inhibitor secukinumab demonstrated statistically significant skin clearance, according to in 2 pivotal phase 3 studies published in The New England Journal of Medicine.

Secukinumab met all primary and key secondary end points in the ERASURE and FIXTURE studies, including Psoriasis Area and Severity Index (PASI) 75 and 90, and Investigator’s Global Assessment modified 2011 (IGA mod 2011) 0/1 responses at Week 12.

ERASURE (Efficacy of Response And Safety of two fixed secUkinumab Regimens in psoriasis) was a randomized double-blind, placebo-controlled, multicenter, parallel-group phase 3 study involving 738 patients with moderate-to-severe plaque psoriasis in psoriasis. In ERASUE, a higher proportion of patients treated with secukinumab 300 mg and 150 mg achieved a PASI 75 response at Week 12 compared to placebo patients, 81.6% (300 mg) and 71.6% (150 mg), versus 4.5% for placebo (P<.001). On the co-primary end point, a higher proportion of patients treated with secukinumab achieved an IGA mod 2011 0/1 response at Week 12 compared to placebo, 65.3% (300 mg) and 51.2% (150 mg), versus 2.4% for placebo (P <.001).

Additionally:

• At Week 12, 59.2% (300 mg) and 39.1% (150 mg) of secukinumab patients achieved a PASI 90 response compared to 1.2% of placebo patients (P <.001).

• The percentage of patients who achieved a PASI 75 response at Week 12 and maintained the response at Week 52 with continued treatment was 80.5% (300 mg) and 72.4% (150 mg).

• The percentage of patients who achieved an IGA mod 2011 0/1 response at Week 12 and maintained the response at Week 52 with continued treatment were 74.4% (300 mg) and 59.2% (150 mg)

FIXTURE (the Full year Investigative eXamination of secukinumab vs. eTanercept Using 2 dosing Regimens to determine Efficacy in psoriasis) was a randomized double-blind, placebo and active controlled, multicenter, parallel-group phase 3 study involving 1,306 patients with moderate-to-severe plaque psoriasis. In FIXTURE, a higher proportion of patients treated with secukinumab 300 mg and 150 mg achieved a PASI 75 response at Week 12 compared to placebo: 77.1% (300 mg) and 67.0% (150 mg), versus 4.9% for placebo (P<.001). On the co-primary end point, a higher proportion of patients treated with secukinumab achieved an IGA mod 2011 0/1 response at Week 12 compared to placebo: 62.5% (300 mg) and 51.1% (150 mg), versus 2.8% for placebo (P<.001).

Additionally:

• At Week 12, 54.2% (300 mg) and 41.9% (150 mg) of secukinumab patients achieved a PASI 90 response compared to 1.5% of placebo patients and 20.7% of etanercept patients (P<.001). 

• A higher proportion of secukinumab-treated patients who achieved a PASI 75 response at Week 12 maintained the response at Week 52 with continued treatment compared to etanercept patients: 84.3% (300 mg) (P<.001) and 82.2% (150 mg) (P<.01) versus 72.5% for etanercept.

• The percentage of secukinumab patients who achieved an IGA mod 2011 0/1 response at Week 12 and maintained the response at Week 52 with continued treatment was 79.7% (300 mg) (P<.001) and 67.7% (150 mg) (P<.01) compared to 56.8% of etanercept patients.

In ERASURE, the most common adverse events (AEs) in any treatment group including placebo (n=738) were nasopharyngitis, headache, and upper respiratory tract infection. Eighteen patients in the secukinumab 300 mg arm, 12 patients in the secukinumab 150 mg arm, and 5 patients in the placebo group discontinued the study due to AEs. Serious AEs during the entire treatment period were reported at rates (in events per 100 subject-years) of 6.3 (300 mg), 6.4 (150 mg), and 7.4 (placebo).

In FIXTURE, the most common AEs in any treatment group including etanercept and placebo (n=1,306) were nasopharyngitis, headache, and diarrhea. Fourteen patients in the secukinumab 300 mg arm, 10 patients in the secukinumab 150 mg arm, 12 patients in the etanercept arm and 3 patients in the placebo arm discontinued due to AEs. Serious AEs during the entire treatment period were reported at rates (in events per 100 subject-years) of 6.8 (300 mg), 6.0 (150 mg), 7.0 (etanercept), and 8.3 (placebo) with no clinically apparent differences in the type of serious AEs among treatment groups. There were no deaths reported although there was one death unrelated to psoriasis during the FIXTURE screening period.

Novartis sponsored the studies.