Risankizumab shows faster response in bio naïve than in bio‐experienced psoriatic patients

Editor Risankizumab showed high levels of efficacy and safety in the treatment of moderate-to-severe psoriasis in clinical trial and numerous real-life studies, with an achievement of PASI90 (psoriasis area severity index) variable from 59% to >70%. Despite numerous real-world experiences published in recent years, consistent data at 40 and 52 weeks of treatment are still lacking. Minimal differences in response in favour of bio-na€ıve, nonobese population and in patients without joint involvement are shown in recent studies. A retrospective multicentre study with the aim of analysing efficacy and safety of risankizumab at 16, 28, 40 and 52 weeks in adult psoriatic patients was conducted in 10 dermatology units of the Piedmont region in Northern Italy. Data on mean and relative PASI, mean DLQI and DLQI0/1, and adverse events were collected at patient visits at weeks 16, 28, 40 and 52. Since September 2020, a total of 236 psoriatic patients have been treated with Risankizumab. Patients’ characteristics were collected, see Table 1 and Fig. 1. The meanPASI score fell from 14.8 at baseline, to 2.7 at week 16. Reduction was maintained at 28, 40 and 52 weeks. DLQI fell, from a mean of 19.4 at baseline to 1 and 0.8, at 40 and 52 weeks, respectively (P < 0.001), with a DLQI0/1 response of 78% and 83%. PASI100 was observed in 33%, 60%, 70% and 75% of patients at weeks 16, 28, 40 and 52. PASI90 was achieved by 49%, 75%, 78% and 82% of patients at weeks 16, 28, 40 and 52 respectively. PASI75 was achieved by 68% 86%, 91% and 91% of patients at weeks 16, 28, 40 and 52. PASI < 3 was achieved by 63%, 85%, 92% and 95% of patients at weeks 16, 28, 40 and 52 respectively. Bio-na€ıve patients presented a PASI significantly superior to the bio-experienced at baseline (15.5 vs. 14, P = 0.028). This is because bio-na€ıve patients are candidates for biological treatment with a higher PASI than bio-experienced patients who have taken risankizumab following initial secondary inefficacy. Bio-experienced patients achieved PASI90 less than bio-na€ıve (40.41% vs. 55%, P = 0.041) at 16 weeks, differences was also detected in PASI90, 75 and PASI < 3 at week 28 between the two populations (65% vs. 84%, 77% vs. 93% and 78% vs. 91%, P = 0.003, P = 0.001 and P = 0.011 respectively). At week 40, differences were detected in the achievement PASI75 and PASI < 3 between bio-experienced and bio-na€ıve 85% vs. 95% and 87% vs. 96% respectively (P = 0.032 and P = 0.026). Minor differences were observed respect the presence of joint involvement or obese status. Twenty-two patients (9%) interrupted the treatment: 13 due to primary inefficacy, four for adverse events, two for pregnancy, two patients were lost to follow-up and one patient died for another comorbidity (chronic ischaemic heart disease). Our real-life study shows efficacy in reducing mean PASI and achieving relative PASI like those reported in registration studies, with less effectiveness in achieving PASI100 and 90 at the first weeks of treatment. These data highlight a slower response-trend in clinical practice than reported in registration studies, as previously shown in other real-life studies. In contrast to recent real-life studies, we did not observe a significant reduction in response in the obese and PSA patient. Risankizumab showed good impact on quality of life with a major reduction of DLQI in our population at week 52 compared to UltIMMa-1 and -2. Our data show a faster response of risankizumab in bio-na€ıve patients compared to bio-experienced, in reaching PASI90, 75 and <3, from weeks 16 to 40. It is interesting to note that at 52 weeks these differences faded, confirming the overall efficacy of the drug even in multi-failure patients, as recently highlighted by some report.