Risankizumab proven safe, effective in bio-naïve psoriasis patients

Treatment with risankizumab (RZB) results in significantly lower absolute Psoriasis Area and Severity Index (PASI) and Dermatology Life Quality Index (DLQI) scores at week 52 in bio-naïve psoriasis patients compared with other biologic therapies, according to the results of a 2-year interim analysis from the German cohort of the VALUE study, presented at EADV 2023.

The beneficial effects of RZB have persisted over 100 weeks. In addition, patients receiving RZB are less likely to switch to other biologics.

“RZB is an interleukin-23 p19 inhibitor biologic drug approved for the treatment of moderate-to-severe plaque psoriasis and psoriatic arthritis,” said the researchers, led by Dr Thomas Staermann, a private practitioner in Berlin, Germany. “Real world data of RZB on the long-term effectiveness is limited, especially for bio-naïve patients.”

Staermann and his colleagues assessed the real-world durability of response and time to first treatment change for RZB compared to other biologic treatments in bio-naïve patients with psoriasis. Treatment decisions were carried out at the physician’s discretion based on local label and clinical practice. The researchers analysed a German subpopulation.

Subsequently, Staermann and his team obtained the PASI, DLQI, Treatment Satisfaction Questionnaire for Medication (TSQM), and changes to treatment at weeks 0, 4, and every 12 weeks thereafter. They also evaluated the safety of RZB through reported adverse events (AEs).

A total of 571 patients with moderate to severe psoriasis in Germany were included in this analysis. Of these, 387 were treated with RZB (bio-naïve patients: n=206, 53.2 percent) and 191 with other biologics (bio-naïve patients: n=109, 59.2 percent). [EADV 2023, abstract 87]

Effectiveness and safety

Bio-naïve patients who received RZB had significantly higher PASI scores (19.1 vs 16.4; p=0.0068) and higher DLQI scores (15.1 vs 13.1; p=0.0217) than bio-naïve patients who received other biologic therapies at baseline.

Afterwards, bio-naïve patients on RZB treatment showed significantly lower PASI scores at week 52 (0.9 vs 2.6; p=0.0326) and week 100 (0.7 vs 3.3; p=0.0052) than their bio-naïve counterparts receiving other biologic treatments.

Similarly, the RZB group demonstrated significantly lower DLQI scores than those treated with other biologics at week 52 (1.7 vs 2.9) and week 100 (1.5 vs 4.2). In addition, patients receiving RZB had markedly higher TSQM global satisfaction scores at week 52 (92.4 percent vs 84.5 percent; p=0.0044) and week 100 (93.5 percent vs 82.7 percent; p=0.0206).

“Within 100 weeks, any change of treatment (including discontinuation, dose escalation, and dosing interval shortening) was lower in bio-naïve RZB patients (9.2 percent) compared to bio-naïve patients [treated] with other biologics (18.3 percent; p=0.0193),” according to the researchers.

In terms of safety, 65 bio-naïve patients treated with RZB (31.6 percent) reported experiencing AEs, and only 16 participants (7.8 percent) encountered serious AEs. Treatment discontinuation due to AE was documented in 12 patients (5.8 percent). Overall, these rates were considered low by the researchers.