The recent STEPIn study found that patients with moderate to severe plaque psoriasis had better outcomes with secukinumab compared with narrowband ultraviolet B (nb-UVB) phototherapy.
Study investigators were led by Lars Iversen, MD, at the Department of Dermatology and Venereology at Aarhus University Hospital, Denmark.
Their research was designed to assess whether psoriasis patients with early intervention with secukinumab were more helpful than traditional treatment using nb-UVB phototherapy.
“The purpose of this primary analysis of the STEPIn trial is to determine whether early intervention with secukinumab in patients with moderate to severe plaque psoriasis of recent onset is superior to standard care with narrowband ultraviolet B (nb-UVB) phototherapy in achieving sustained clearance. of the skin,” wrote Iversen and his colleagues.
STEPIn was an open-label, multicentre, randomized trial, and the investigators’ overall objective was to compare 52 weeks of subcutaneous secukinumab therapy at 300 mg with nb-UVB phototherapy in patients with new-onset psoriasis (≤12 months).
The STEPIn investigators noted that the primary endpoint was ≥90% improvement in the Psoriasis Area and Severity Index (PASI 90) score after 52 weeks.
The secondary endpoint for the study was a 0/1 Investigator Global Assessment (IGA) response at the same time.
The research team used serum β-defensin 2 concentration as a biomarker for skin clearance and relapse at baseline, 16 weeks, and 52 weeks.
They used high-sensitivity C-reactive protein (hsCRP) as a marker of systemic inflammation at baseline, 16, 24, 36, and 52 weeks.
STEPIn investigators noted that 77 of 80 and 76 of 80 patients randomized to the secukinumab and nb-UVB groups received a minimal single dose of treatment, respectively.
They stated that their primary endpoint was met, with 70 of 77 patients (about 91%) achieving PASI 90 responses after 52 weeks on secukinumab, compared with 32 of 76 (about 42%) of those receiving nb-UVB (P < 0.0001, odds ratio [OR] I estimated [95% CI] = 16.3 [5.6, 46.9]).
Additionally, the STEPIn secondary endpoint was reached, with 85.7% of study participants reporting an IGA 0/1 response after 52 weeks of secukinumab compared to 36.8% of those in the nb-UVB group (P < 0.0001).
The investigators added that the safety data for the treatments were consistent with the safety profiles of both treatments and that they found no other safety signals in the study.
“Secukinumab was superior to nb-UVB in the treatment of patients with moderate to severe plaque psoriasis of recent onset,” they wrote. “The observed high and sustained skin clearance indicates that biological treatment for psoriasis may be more effective if used early in the disease course.”
The study, “Secukinumab Demonstrates Superiority Over Narrowband Ultraviolet B Phototherapy in Patients with New-Onset Moderate to Severe Plaque Psoriasis: Week 52 Results of the STEPIn Trial,” was published online at Journal of the European Academy of Dermatology and Venereology.