Risankizumab has been recently approved for moderate‐to‐severe plaque psoriasis; however, real‐life studies are scarce. Analysis of possible predictor factors of treatment response are limited to body mass index (BMI) and previous biologic experience. Our objectives were to evaluate the effectiveness and safety of Risankizumab and to investigate on possible predictor factors response. We retrospectively analyzed 166 patients from two centers in Italy who undergone Risankizumab for psoriasis. The proportion of patients achieving a 100%, 90%, 75% of improvement in Psoriasis Area Severity Index (PASI) and PASI <3 were collected at weeks 16, 28, 40, and 52. Study population was analyzed in subgroups to investigate possible predictors of response to Risankizumab since week 40. At the time of analysis 165, 103, 30, and 11 patients had completed 16, 28, 40, and 52 weeks of treatment, respectively. The mean PASI score decreased from 12.5 ± 5.1 at baseline to 1.9 ± 2.4 at week 16. Similar reductions were observed when considering PASI <3, PASI 75, PASI 90, and PASI 100. Previous biologics failure, different smoking habits, obesity, and joint involvement resulted in a lower response to risankizumab. In particular, significant differences in mean PASI at any time‐points was observed between psoriatic arthritis (PSA) and non‐PSA patients: 2.7 versus 1.7 (p = 0.036), 1.9 versus 0.4 (p = 0.006), and 4.1 versus 0.5 (p = 0.016) at 16, 28, and 40 weeks, respectively. No difference in response to risankizumab occurred in the case of involvement of difficult‐to‐treat areas. In this population, Risankizumab was effective and safe. Smoking habits, joint involvement, obese status, and previous biologic experience may negatively affect treatment response, while difficult body sites involvement have minor impact.
EditorRisankizumab 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%. [1][2][3][4][5] Despite numerous real-world experiences published in recent years, consistent data at 40 and 52 weeks of treatment are still lacking. 1,6,7 Minimal differences in response in favour of bio-na€ ıve, nonobese population and in patients without joint involvement are shown in recent studies. 1,6,9 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. [1][2][3] These data hi...
BackgroundMany national guidelines at the European level recommend first‐line therapy based on the anti‐TNF‐alpha adalimumab for treatment of psoriasis and psoriatic arthritis, mainly for economic reasons. Consequently, patients being treated with newer IL‐17 and IL‐23 inhibitors underwent previous unsuccessful first‐line adalimumab‐based therapy.ObjectivesEvaluate the efficacy and safety of IL‐17 and IL‐23 inhibitors after treatment with adalimumab compared to adalimumab‐naive psoriatic patients.MethodsWe retrospectively analysed 1053 psoriatic patients treated with anti‐IL17 and anti‐IL23 agents, which included 68 and 24 adalimumab‐experienced and 399 and 260 bio‐naive patients. Efficacy was assessed with mean PASI, PASI90, PASI100, and <3.ResultsConcerning the achieving of PASI100, PASI90 and PASI < 3 in patients treated with anti‐IL17 agents, no significant differences were observed between adalimumab‐experienced and bio‐naive patients. In patients treated with an anti‐IL‐23 agent, a faster response was observed in bio‐naive patients, with PASI < 3 significantly higher than ADA‐experienced patients at 16 weeks (77% vs. 58% p = 0.048). In a sub‐analysis that evaluated the performance of anti‐IL17 and anti‐IL23 agents in adalimumab‐experienced patients with a history of secondary failure, no significant differences were found. In multivariate analysis of PASI100, only anti‐IL‐17 therapy appeared to have a negative impact at 52 weeks (OR: 0.54 p = 0.04) independently of previous treatment. For PASI90, type of treatment and bio‐naïve status did not seem to have an impact at any time point.ConclusionsAnti‐IL 23 and anti‐IL 17 agents are not significantly different in terms of efficacy in bio‐naive patients or as second‐line therapy after failure with a biosimilar or originator adalimumab.
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