Adalimumab improves moderate-to-severe nail psoriasis
Treatment with adalimumab vs placebo for 26 weeks leads to significant improvements in the primary and all ranked secondary endpoints, as well as in signs and symptoms of moderate-to-severe nail psoriasis, with no new safety risks involved, reports a recent phase III trial.
“Adalimumab should be considered for treatment of patients with moderate-to-severe psoriasis who have as little as 5-percent body surface area (BSA) and moderate-to-severe fingernail psoriasis,” researchers said.
In this study, a total of 217 patients were randomly assigned 1:1 to 40-mg adalimumab (n=109) every other week or placebo (n=108). The primary efficacy endpoint was at least 75-percent improvement in total-fingernail modified Nail Psoriasis Severity Index (NAPSI75) response rate at week 26.
Ranked secondary endpoint scores evaluated at week 26 included total-fingernail NAPSI and modified NAPSI, nail pain, Nail Psoriasis Physical Functioning Severity, Brigham Scalp Nail Inverse Palmo-Plantar Psoriasis Index, and Physician’s Global Assessment (fingernail psoriasis).
Of the participants, 188 (86.6 percent) completed 26 weeks of treatment (period A) or escaped early to the open-label period.
The primary endpoint (response rate, 46.6 percent with adalimumab vs 3.4 percent with placebo; p<0.001) and all ranked secondary endpoints were met. Serious adverse event rates in period A were 7.3 percent vs 4.6 percent with adalimumab and placebo, respectively. In addition, the corresponding serious infection rates were 3.7 percent vs 1.9 percent. [J Am Acad Dermatol 2018;78:90-99.e1]
“Few patients achieved completely normal nails (6.6 percent at 26 weeks),” researchers said. “However, full regrowth may not have completely occurred by 26 weeks.”
“These results also support recently published nail psoriasis guidelines identifying adalimumab as a recommended biologic treatment for patients with significant nail disease and with concomitant, significant skin and/or joint disease,” they added. [JAMA Dermatol 2015;151:87-94; J Cutan Med Surg 2016;20:375-431]
On the other hand, several patients with psoriasis are not considered for systemic therapy if they lack at least 10-percent BSA involvement, despite experiencing considerable morbidity for their nail psoriasis disease manifested as nail pain or impairment in nail function, according to researchers.
“Although this study also enrolled patients with at least 5-percent psoriasis-involved BSA, the associated considerable overall burden of nail disease represented that of moderate-to-severe psoriasis,” said researchers. “This supports existing guideline stating that systemic treatment … is often recommended for patients with skin, nail or scalp psoriasis.” [JAMA Dermatol 2015;151:87-94; Am J Clin Dermatol 2017;18:17-43]
Results of this study with respect to safety support the known adalimumab safety profile for dermatologic and other disease states, but the serious infection rate was greater than in other trials evaluating patients with moderate-to-severe psoriasis and psoriasis of the hands and feet. [Arch Dermatol 2011;147:429-436; Br J Dermatol 2010;163:402-411; Br J Dermatol 2008;158:558-566; J Am Acad Dermatol 2008;58:106-115]
“This study was limited by the requirement of at least 5-percent affected BSA involvement, the small sample size of patients with scalp psoriasis and a lack of power to robustly compare the safety of adalimumab vs placebo,” researchers said. “Also, the definition of ‘clinically meaningful’ has not been validated in nail psoriasis.”