P97 Risankizumab real-world effectiveness in UK clinical practice: results from the BADBIR registry
Authors: Shams Kave , Bartlett Sean , Millward Rachael , Sharma Kavita , Bennett Mark 
Published: June 2023

Abstract
Risankizumab is an anti-interleukin (IL)-23 monoclonal antibody approved for the treatment of psoriasis and psoriatic arthritis (PsA) in the UK. IL-23 is a key regulatory cytokine that is essential for the activation of pathogenic T helper 17 cells that stimulate inflammation in psoriasis and PsA. The efficacy and safety profile of risankizumab has been demonstrated in multiple clinical studies [Gordon KB, Strober B, Lebwohl M et al. Efficacy and safety of risankizumab in moderate-to-severe plaque psoriasis (UltIMMa-1 and UltIMMa-2): results from two double-blind, randomised, placebo-controlled and ustekinumab-controlled phase 3 trials. Lancet 2018; 392:650–61]; however, the real-world effectiveness of risankizumab in UK clinical practice is not well characterized. Using BADBIR data up to 1 September 2022, we report drug survival up to 24 months in biologic-naïve and biologic-experienced patients treated with risankizumab for psoriasis. Drug survival was estimated by the Kaplan–Meier method in patients with ≥ 6 months of follow-up, with censoring at the last observation or end of the study period. Treatment effectiveness was assessed by best absolute Psoriasis Area and Severity Index (aPASI) or Dermatology Life Quality Index (DLQI) at a mean (SD) of 12 (2) months in an available case analysis. In total, 569 patients received risankizumab of whom 117 (20.6%) were biologic naïve at the start of risankizumab. In biologic-experienced patients, 166/452 patients (36.7%) received risankizumab as second-line, 123 (27.2%) as a third-line, 77 (17.0%) as a fourth-line and 86 (19.0%) as a fifth-line or higher agent. The median observed follow-up was 1.1 years [interquartile range (IQR) 0.6–1.6] for biologic-naïve patients and 1.5 years (IQR 0.9–2.2) for biologic-experienced patients. Many characteristics, including patient age, sex and disease duration, were similar between groups. Overall, 92 (16.2%) patients had a diagnosis of PsA [n = 9/117 (biologic naïve) vs. n = 83/452 (biologic experienced)]. Unadjusted risankizumab drug survival at 12 months was 91% (95% confidence interval 81–96) for biologic-naïve patients and 91% (95% CI 87–93) for biologic-experienced patients. In total, there were 53/419 (12.6%) discontinuations, attributed to ineffectiveness (n = 22; 5.2%), adverse events (n = 13; 3.1%) and other reasons (n = 18; 4.3%). Of the 69 biologic-naïve patients who discontinued, four (6%) discontinued owing to ineffectiveness, one discontinued (1%) owing to adverse events and four (6%) discontinued for other reasons. Of the 350 biologic-experienced patients that discontinued, 18 (5.1%) discontinued owing to ineffectiveness, 12 (3.4%) discontinued owing to adverse events and 14 (4.0%) discontinued for other reasons. Overall, at 12 months, 71 of 104 (68.3%) patients achieved aPASI ≤ 2 (16 of 19 biologic-naïve patients vs. 55 of 85 biologic-experienced patients) and 34 of 49 (69.4%) achieved DLQI 0/1 (nine of 15 biologic-naïve patients vs. 25/34 biologic-experienced patients). Using real-world data from BADBIR, these results demonstrate that risankizumab is an effective treatment option for psoriasis that maintains a high treatment response for at least 12 months.
Funding sources: AbbVie Ltd.