Secukinumab triumphs over ustekinumab for moderate-to-severe plaque psoriasis
The fully human monoclonal antibody secukinumab triumphed over ustekinumab once again in patients with moderate-to-severe plaque psoriasis, according to the phase IIIb CLARITY* trial presented at the recent annual meeting of the American Academy of Dermatology (AAD 2019).
Participants were 1,102 patients with moderate-to-severe plaque psoriasis who were randomized to receive subcutaneous secukinumab (300 mg; n=550, mean age 45.4 years, 64.7 percent male) or ustekinumab (45 or 90 mg; n=552, mean age 45.3 years, 68.1 percent male). The duration of treatment exposure was similar among secukinumab and ustekinumab recipients (170.8 and 171.1 subject years, respectively).
A greater proportion of patients on secukinumab achieved PASI 90** at week 12 compared with those on ustekinumab (66.5 percent vs 47.9 percent), with the benefit of secukinumab over ustekinumab observed as early as week 4 (16.7 percent vs 4.0 percent) and sustained until week 16 (76.6 percent vs 54.2 percent; p<0.0001 for all comparisons). [AAD 2019, abstract 8681]
Secukinumab was also superior to ustekinumab in terms of the proportion of patients who achieved a score of 0 or 1 (clear or almost clear) on the 5-point modified IGA*** at 12 weeks (72.3 percent vs 55.4 percent), again with results evident from as early as 4 weeks (26.9 percent vs 7.8 percent) and up to 16 weeks into treatment (78.6 percent vs 59.1 percent; p<0.0001 for all comparisons).
Patients also reported better quality of life on secukinumab compared with ustekinumab, as assessed by the Dermatology Life Quality Index (DLQI) with a 0 or 1 response reported by 33.9 percent vs 18.0 percent at week 4, 64.0 percent vs 51.7 percent at week 12, and 68.4 percent vs 55.9 percent at week 16 (p<0.0001 for all comparisons).
The incidence of treatment-emergent adverse events (TEAEs) at week 16 was similar between secukinumab and ustekinumab recipients (47.5 percent vs 46.4 percent). The most frequent TEAEs among secukinumab recipients were upper respiratory tract infections (URTIs) and nasopharyngitis (4.5 percent each) followed by diarrhoea (3.1 percent), whereas URTIs were the most common AE among ustekinumab recipients (6.0 percent) followed by nasopharyngitis (4.5 percent) and headache (2.7 percent). Infections and infestations occurred at a comparable rate between groups (22.2 percent vs 21.2 percent).
Discontinuation rate at week 16 was comparable between secukinumab and ustekinumab recipients (n=18 and 17, respectively), with six and four patients, respectively, discontinuing due to adverse events.
“Secukinumab … [demonstrated] superior efficacy compared [with] ustekinumab across all study outcomes [including quality of life] up to week 16 in patients with moderate-to-severe plaque psoriasis,” said the researchers. “The safety profile of secukinumab remained favourable, with no unexpected safety concerns identified.”
The findings of the CLARITY trial follow up on those of the phase IIIb CLEAR# study which also found secukinumab to be superior to ustekinumab in patients with moderate-to-severe plaque psoriasis, they said. [J Am Acad Dermatol 2017;76:60-69.e9]