VANCOUVER, B.C. – The interleukin-17A inhibitor secukinumab demonstrated the greatest improvement in nail psoriasis ever reported from a randomized, placebo-controlled trial in the phase IIIb TRANSFIGURE study, Dr. Kristian Reich reported at the World Congress of Dermatology.
At 198 patients, TRANSFIGURE is the largest-ever prospective study in patients with moderate to severe chronic plaque psoriasis and significant nail involvement. And while only the 16-week results are available thus far, when TRANSFIGURE is completed after a planned 132 weeks of treatment, it will also be the longest-ever study in the treatment of nail psoriasis, noted Dr. Reich, a dermatologist in group practice in Hamburg, Germany.
Elsewhere at WCD 2015, Dr. Alice B. Gottlieb presented the week 16 results of the phase IIIb GESTURE study, in which 205 psoriasis patients with moderate to severe psoriasis of the palms and soles were randomized to subcutaneous secukinumab (Cosentyx) at 150 or 300 mg or placebo. Dosing was weekly for the first 5 weeks and monthly thereafter.
The primary endpoint, a palmoplantar Investigator’s Global Assessment scale score of 0 or 1 – clear or almost clear – at week 16 was 33.3% with secukinumab at 300 mg, 22.1% at 150 mg, and 1.5% with placebo. The average reduction in palmoplantar PASI (Psoriasis Area Severity Index) score from baseline was 54.6% with high-dose and 35.3% with low-dose secukinumab, compared with 4.1% in placebo-treated controls, reported Dr. Gottlieb, professor and chair of dermatology at Tufts University, Boston.
Like the TRANSFIGURE trial, GESTURE will continue for 132 weeks, with the initial placebo-treated controls being randomized to secukinumab at 150 or 300 mg after week 16.
Dr. Reich reported that by 16 weeks in TRANSFIGURE, mean scores on the Nail Psoriasis Severity Index had improved by 45.3%, compared with baseline, in patients on secukinumab 300 mg, 37.9% in those on secukinumab 150 mg, and 10.8% with placebo.
The results on the skin were dramatic: a PASI 75 rate of 87.1% with secukinumab 300 mg, 77% with secukinumab 150 mg, and 5.1% with placebo. The PASI 100 response rate – meaning totally clear skin – was 31.9% with high-dose and 25.2% with lower-dose secukinumab, while there was a zero PASI 100 rate in controls.
The only adverse events more common than with placebo were nasopharyngitis and upper respiratory infections.
Dr. Reich predicted that as the ongoing TRANSFIGURE study continues well beyond 16 weeks, the nail psoriasis response rates will climb, since nails are so slow growing.
TRANSFIGURE and GESTURE are sponsored by Novartis, which markets secukinumab. Dr. Reich and Dr. Gottlieb reported having financial relationships with Novartis and numerous other pharmaceutical companies.