A recent phase 3, multi-center, randomized, open-label study (NCT03478787) evaluated the efficacy and safety of risankizumab (Skyrizi) compared with that of secukinumab (Cosentyx) in adults with moderate to severe plaque psoriasis.1,2
For this efficacy assessor-blinded, active-comparator study, patients with plaque psoriasis were randomized in a 1:1 ratio to receive either risankizumab or secukinumab. Risankizumab-treated patients (n=164) received 150 mg administered as two 75 mg subcutaneous injections at baseline, four weeks and every 12 weeks thereafter. Secukinumab-treated patients (n=163) received 300 mg administered as two 150 mg subcutaneous injections at baseline, at Weeks 1, 2, 3 and 4, and every four weeks thereafter.
The study’s primary endpoints were non-inferiority at Week 16 and superiority at Week 52, both for PASI 90. Additionally, researchers evaluated three, ranked secondary endpoints: PASI 100 at Week 52, the static Physician’s Global Assessment (sPGA) 0/1 at Week 52 and PASI 75 at Week 52. A safety assessment was done for all patients.
Risankizumab-treated patients met both primary and all ranked secondary endpoints compared with secukinumab.
At Week 16, risankizumab-treated patients met the primary endpoint of non-inferiority to secukinumab-treated patients, with 74% of patients achieving PASI 90 vs. 66%. Risankizumab-treated patients also had significantly higher skin clearance rates than secukinumab-treated patients (87% vs. 57%; P<0.001), meeting the primary endpoint at Week 52 of PASI 90.
The rates of adverse events were comparable between risankizumab and secukinumab. For both groups, the most common adverse events were nasopharyngitis, upper respiratory tract infections, headache, arthralgia and diarrhea. Both treatment groups had a similar number of discontinuations due to adverse events. No deaths were reported during the study, and no new safety signals were identified for risankizumab.
Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.
- AbbVie Inc. News release: New head-to-head phase 3 data show Skyrizi (risankizumab) superior to Cosentyx (secukinumab) across primary and all ranked secondary endpoints in adults with moderate to severe plaque psoriasis at 52 weeks. 2020 Jan 14.
- AbbVie Inc. Risankizumab versus secukinumab for subjects with moderate to severe plaque psoriasis. ClinicalTrials.gov. 2019 Sep 20.