Secukinumab 300 mg effective, safe for patients with moderate-to-severe scalp psoriasis
Secukinumab has shown efficacy and safety for patients with extensive moderate-to-severe scalp psoriasis, according to a recent study.
“Secukinumab 300 mg provided significantly greater clearance of moderate-to-severe scalp psoriasis than placebo,” researchers said. “These promising results demonstrate the possibility of establishing PSSI 90 (90-percent improvement in Psoriasis Scalp Severity Index) as a new benchmark for scalp psoriasis treatment outcome.”
The investigators conducted a 24-week, double-blind, phase IIIb study, in which 102 patients were randomly assigned 1:1 to either subcutaneous secukinumab 300 mg or placebo at baseline, weeks 1, 2 and 3, and then every 4 weeks from week 4 to 20. The primary efficacy variable was PSSI 90 score from baseline to week 12.
Compared with patients receiving placebo, those who received secukinumab 300 mg had significantly greater PSSI 90 (52.9 vs 2.0 percent) and Investigator’s Global Assessment (IGA) modified 2011 scalp responses of 0 or 1 (56.9 vs 5.9 percent) at week 12 (p<0.001 for both). Additionally, more patients in the secukinumab 300 mg group had achieved complete clearance of scalp psoriasis at week 12 than those in the placebo group (35.3 vs 0 percent; p<0.001). [J Am Acad Dermatol 2017;77:667–674]
“Secukinumab treatment alone without concomitant scalp psoriasis treatment is efficacious and well tolerated in moderate-to-severe scalp psoriasis,” researchers said.
“Both the primary and key secondary objectives of this study were met with secukinumab 300 mg, which provided significantly greater PSSI 90 and IGA mod 2011 scalp 0 or 1 responses than placebo at week 12. The proportion of patients achieving a PSSI 100 response at week 12 was also significantly greater with secukinumab 300 mg than placebo,” they added.
There was a median time to 50-percent reduction in PSSI score of 3.29 weeks with secukinumab 300 mg. The safety profile of secukinumab was consistent with previous phase III studies. [N Engl J Med 2014;371:326–338; J Am Acad Dermatol 2016;75:83–98.e84; J Eur Acad Dermatol Venereol 2015;29:1082–1090; Br J Dermatol 2015;172:484–493]
“No new or unexpected safety signals developed over 24 weeks of treatment with secukinumab. There were no deaths, cases of major adverse cardiac events, neutropaenia grades 3 or 4, malignancy, or inflammatory bowel disease,” researchers said.
A single case of vulvovaginal candidiasis in the secukinumab treatment group was reported, but it was resolved with treatment and did not lead to discontinuation of secukinumab, researchers noted.
The current study was limited by the lack of an active comparator. Researchers recommended future studies directly comparing biologics, which may help physicians with therapy selection.