Secukinumab well-tolerated in patients with scalp psoriasis
Common side effects of scalp psoriasis include itching, scratching, loss of sleep, an increase in presenteeism, absenteeism, and not wearing dark clothing due to embarrassment.
Secukinumab, an interleukin 17A-selective human monoclonal antibody, was shown to be effective and well tolerated in patients with moderate-to-severe scalp psoriasis, according to recent findings published in the Journal of the American Academy of Dermatology.1
This study was the first to evaluate systemic pharmacotherapy for scalp psoriasis in which participants were not required to also have moderate-to-severe body plaque psoriasis.
The researchers advocated for systemic therapy for scalp psoriasis, pointing to several previous studies showing that topical treatments are less effective than systemic agents, in part because hair makes it challenging to use ointments and cream-based products, leading to poor adherence.2-4
In the 24-week, double-blind, placebo-controlled, parallel-group, multicenter, phase 3b study, 102 patients were randomly selected to take either secukinumab 300 mg or placebo. Moderate-to-severe scalp psoriasis was defined as a Psoriasis Scalp Severity Index (PSSI) score of ≥12 on a scale of 0 to 72, with ≥30% of the scalp surface area affected. Inclusion criteria also included an Investigator's Global Assessment modified 2011 (IGA mod 2011) scalp-only score of ≥3 on a 0- to 4-point scale. The IGA mod 2011 is a modified tool for evaluating plaque psoriasis severity in clinical trials.5
In 2 consecutive 12-week treatment periods, patients in the placebo arm who achieved a PSSI improvement of 90% at week 12 continued receiving placebo and those who did not were switched to secukinumab. The study agents were both self-administered in accordance with secukinumab labeling directions: 2 subcutaneous injections using a single-use prefilled syringe at weeks 1, 2, and 3, and then every 4 weeks. Patients were treated through week 20, with final efficacy data evaluated at week 24.
At baseline, the mean PSSI score was 33.2, average scalp surface area affected was 60%, and 43% of patients had ≥70% of scalp surface area affected. However, at week 12, a 90% improvement in PSSI score was achieved in 53% of patients receiving secukinumab compared with 2% of patients receiving placebo (P<.001). No patient receiving placebo achieved complete clearance of scalp psoriasis at week 12, although 35% of patients receiving active therapy did so. In addition, an IGA mod 2011 scalp score of 0 or 1 was achieved in 57% of patients receiving secukinumab vs 6% of patients receiving placebo (P<.001). Improvements were rapid, according to the study authors, being noticeable as early as week 3.
"Scalp psoriasis has a significant impact on quality of life. Itching, scratching, loss of sleep, an increase in presenteeism, absenteeism, and not wearing dark clothing due to embarrassment are common symptoms," lead author Jerry Bagel, MD, told Dermatology Advisor. Dr. Bagel is the director of the Psoriasis Treatment Center of Central New Jersey in East Windsor.
"This study shows, for the first time, that more than 50% of patients can expect a 90% or greater improvement in scalp psoriasis within 12 weeks," he said, adding that no serious adverse events occurred within the study population of more than 100 persons administered secukinumab.
Summary and Clinical Applicability
Scalp psoriasis can have a significant impact on quality of life, and topical treatments have been shown to be less effective than systemic agents. The interleukin 17A-selective human monoclonal antibody secukinumab was shown to be safe and effective in resolving moderate-to-severe scalp psoriasis in the first study to evaluate systemic pharmacotherapy for scalp psoriasis that did not also require participants to have moderate-to-severe body plaque psoriasis.
Limitations and Disclosures
There was no active comparator arm in this study, which was supported by Novartis Pharmaceuticals Corporation.
- Bagel J, Duffin KC, Moore A, et al. The effect of secukinumab on moderate-to-severe scalp psoriasis: results of a 24-week, randomized, double-blind, placebo-controlled phase 3b study [published online August 2, 2017]. J Am Acad Dermatol. doi: 10.1016/j.jaad.2017.05.033
- Blakely K, Gooderham M. Management of scalp psoriasis: current perspectives. Psoriasis: Targets and Therapy. 2016;6:33-40.
- Kragballe K. Management of difficult to treat locations of psoriasis: scalp, face, flexures, palm/soles and nails. Curr Prob Dermatol. 2009;38:160-171.
- Mason AR, Mason JM, Cork MJ, Hancock H, Dooley G. Topical treatments for chronic plaque psoriasis of the scalp: a systematic review. Br J Dermatol. 2013;169:519-527.
- J Langley RG, Feldman SR, Nyirady J, van de Kerkhof P, Papavassilis C. The 5-point Investigator's Global Assessment (IGA) Scale: a modified tool for evaluating plaque psoriasis severity in clinical trials. J Dermatolog Treat. 2015;26:23-31.