“Nails are hard to treat in psoriasis and we need better treatments,” says Dr. Luis Garza, a dermatologist at Johns Hopkins School of Medicine in Baltimore, who was not involved in the research.
“JAK inhibitors look like they can definitely help,” he tells Reuters Health by email.
The study, online April 7 in the Journal of the American Academy of Dermatology, is a post-hoc analysis of pooled data from two 52-week, multisite, double-blind Phase 3 randomized trials (OPT Pivotal 1 and 2).¹
OPT Pivotal 1 and 2 included more than 1,800 patients with moderate to severe plaque psoriasis. Approximately 25% reported a medical history of psoriatic arthritis.
All patients were randomized 2:2:1 to receive 5 or 10 mg tofacitinib or placebo twice daily. At Week 16, those receiving placebo were re-randomized to the two treatment groups. Clinical non-responders were discontinued at Week 28.
The post-hoc analysis, by Dr. Joseph F. Merola from Brigham and Women’s Hospital in Boston and colleagues, included 1,196 patients with nail psoriasis at baseline. They were assessed by Nail Psoriasis Severity Index (NAPSI) score.
At baseline, patients had an average of seven affected fingernails and mean NAPSI scores ranging from 26.9 to 27.3 across the groups.
Outcomes at week 16 showed that significantly more patients in the tofacitinib groups achieved 50%, 75%, or 100% reductions in NAPSI scores compared with the placebo group.
NAPSI scores fell 50% from baseline in 32.8%, 44.2% and 12% of patients in the 5 mg, 10 mg and placebo groups, respectively; 16.9%, 28.1% and 6.8% saw drops of at least 75%, and 10.3%, 18.2% and 5.1% achieved complete clearance (100% NAPSI-score reduction).
Improvements continued through week 28 and were sustained to Week 52, with complete clearance in 16% of 5 mg patients and 29% of those receiving 10 mg.
The mean number of affected nails decreased to 3.5 and 2.7 in the 5 mg and 10 mg groups,respectively, at Week 52.
Improvements in crossover patients were similar to those who received treated throughout the study. However, NAPSI score declines were lower in patients with psoriatic arthritis.
Dr. Thomas Knackstedt, a dermatologist who specializes in nail disorders at Cleveland Clinic in Cleveland, tells Reuters Health that intralesional steroid injections are an effective way to avoid systemic therapy in patients with disease confined to the nails and minimal cutaneous or joint involvement.
Dr. Knackstedt, who was not involved in the study, says that the importance of nail health and the management of nail disease are often neglected or seen as an afterthought.
“Tofacitinib will have clinical utility in managing patients with moderate-to-severe plaque psoriasis who also have nail involvement,” he says.
- Merola JF, Elewski B, Tatulych S, et al. Efficacy of tofacitinib for the treatment of nail psoriasis: Two 52-week, randomized, controlled phase 3 studies in patients with moderate-to-severe plaque psoriasis. J Am Acad Dermatol. 2017 Apr 7. pii:S0190–9622(17)30147-0. doi:10.1016/j.jaad.2017.01.053. [Epub ahead of print]