Risankizumab outdoes ustekinumab in plaque psoriasis
The humanized immunoglobulin G1 monoclonal antibody risankizumab provided durable clinical efficacy compared with ustekinumab in individuals with moderate-to-severe plaque psoriasis, according to integrated analyses of UltIMMa-1 and 2* presented at AAD 2019.
A total of 598 participants were randomized 3:1:1 to receive either risankizumab 150 mg, ustekinumab 45 mg (for a body weight of ≤100 kg) or 90 mg (for >100 kg), or placebo at weeks 0 and 4. Placebo recipients were switched to risankizumab at week 16, while others continued with their original regimen. Psoriasis Area and Severity Index 90 (PASI ≥90 percent improvement from baseline) and static Physician’s Global Assessment (sPGA) 0/1 responses were evaluated at week 52. [AAD 2019, abstract 9780]
The clinical outcomes with risankizumab were superior to ustekinumab, with a significantly higher proportion of risankizumab recipients achieving PASI 90 across all subgroups** (p<0.001 for all), which ranged from 77.6 to 85.9 percent compared with 30.8 to 56.3 percent of ustekinumab recipients.
The proportion of patients achieving sPGA 0/1 was also higher in the risankizumab vs the ustekinumab arm (p<0.001 for all except BMI <25 kg/m2; p=0.008), ranging from 79.5 to 90.6 percent vs 39.4 to 65.2 percent.
The incidence of treatment-emergent adverse events (TEAEs) was comparable between the risankizumab and ustekinumab arms (70.1 percent vs 78.9 percent, respectively).
The high PASI 90 and sPGA 0/1 scores suggest that risankizumab provided high and durable skin clearance through 52 weeks compared with ustekinumab, regardless of baseline demographics or disease characteristics, noted the researchers. These findings address the importance of establishing a treatment regimen that can provide predictable and durable skin clearance with an appropriate and convenient dosing regimen for patients with psoriasis to improve quality of life. [Drugs R D 2017;17:29-51; Clinic Rev Allerg Immunol 2018;55:295-311; JEADV 2017;31:213-220]
Another integrated analysis of UltIMMa-1 and 2 showed similar results, with a greater fraction of risankizumab recipients achieving PASI 90 and sPGA 0/1 vs ustekinumab recipients at 1 year (81.3 percent vs 47.2 percent; p<0.001 [PASI 90] and 84.8 percent vs 54.3 percent; p<0.001 [sPGA 0/1]). [AAD 2019, abstract 8108]
PASI 75 and PASI 100 were also higher in the risankizumab vs the ustekinumab arm (91.6 percent vs 73.4 percent; p<0.001 [PASI 75] and 57.9 percent vs 25.6 percent; p<0.001 [PASI 100]).
Overall, mean PASI improvement from baseline was achieved after just two doses of risankizumab (from 57.6 percent [week 4] to 91.1 percent [week 16]) and was sustained throughout 52 weeks of therapy (94.6 percent).
Similar safety profiles were also observed between risankizumab and ustekinumab (TEAE incidence, 70.1 percent vs 78.9 percent), with similarly low rates of serious AEs (7.0 percent vs 9.0 percent) and AEs leading to treatment discontinuation (0.8 percent vs 2.0 percent).
The early and high skin clearance extending through 52 weeks further support the durable response associated with risankizumab, said the researchers.