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A multicenter study on effectiveness and safety of risankizumab in psoriasis: an Italian 16‐week real‐life experience during the COVID‐19 pandemic

2020; Wiley; Volume: 35; Issue: 3 Linguagem: Inglês

10.1111/jdv.17003

1468-3083

Katharina Hansel, Arianna Zangrilli, Luca Bianchi, Ketty Peris, Andrea Chiricozzi, Annamaria Offidani, Federico Diotallevi, Maria Concetta Fargnoli, Maria Esposito, Paolo Amerio, Giulio Gualdi, Luca Bianchi, Luca Stingeni,

Autoimmune and Inflammatory Disorders Research

Risankizumab is a humanized IgG monoclonal antibody that binds with high affinity and specificity to the p19 subunit and selectively inhibits IL-23, critical for psoriatic inflammation. In phase-3 trials (UltIMMa-1, UltIMMa-2 and IMMvent) risankizumab demonstrated early and sustained efficacy at 12-week dosing in patients with moderate-to-severe psoriasis.1, 2 To date, limited real-life data are available on its effectiveness and safety.3 We conducted a real-life multicenter study from December 2019 to May 2020 in Central Italy on the effectiveness and safety of risankizumab at week 16 in psoriasis. Data on demographics, comorbidities, psoriasis history (onset age, previous treatments) and characteristics (PASI, PGA, DLQI, NRS itch, NRS pain, special involved sites) at baseline, week 4 and week 16, as well as safety data, were collected. The study, approved by the local Ethics Committees, started immediately before the beginning of COVID-19 pandemic and data on SARS-CoV-2 infection or contact were also collected. A total of 57 patients affected by psoriasis (mean duration: 27.6 years) were included. Almost all patients had systemic immunosuppressive therapies previously. All patients completed the 16-week therapy with risankizumab, that was the first-line biologic therapy for psoriasis in 16 patients (28.1%). The remaining 41 patients (71.9%) were previously treated with at least one biologic (mean number 1.8). PASI at baseline was <10 in five patients (8.8%), 10–20 in 25 (43.9%) and ≥20 in 27 (47.3%). The effectiveness of risankizumab at week 4 and 16 evaluated according to gender, PASI at baseline, BMI, and prior biologic experience, is reported in Table 1. Overall, 49.1% reached PASI-100 at week 16, more females (63.2%) than males (42.1%). At week 16, risankizumab resulted more effective in patients with PASI ≥20 than in those with PASI <20 at baseline, especially for PASI-75 (100% vs. 73.3%, P = 0.003) and PASI-90 (77.8% vs. 50.0%, P = 0.03). Higher PASI-75, 90 and 100 responses were observed in patients with BMI <25, while biologic experience was irrelevant for therapeutic outcome. Tolerability of risankizumab during the study period was excellent: only one patient (1.8%) experienced upper respiratory tract infection. Three patients (5.3%) had contact with SARS-CoV-2 infected subjects and none of our 57 patients experienced SARS-CoV-2 infection. In our real-life patient population, the effectiveness of risankizumab in terms of PASI-75, 90 and 100 resulted similar to that of phase-3 trials.1, 2 In particular, PASI-100 was achieved by 49.1% of our patients, comparable to that observed in UltIMMa-2 (50.7%) but was higher than that observed in UltIMMa-1 (35.9%) and IMMvent (40.0%). PASI-90 result (63.2%) was lower than that observed in the phase-3 studies (ranging from 72.0% to 75.3%). We underline the rapid onset of response at 4 weeks, documented by 15.8% of patients ranging PASI-90 and 5.3% PASI-100, higher than those observed in IMMvent (6.0% and 2.0%, respectively). Regarding gender, females were more responsive to risankizumab at week 16, probably due to a high frequency of their BMI <25 (68.4%) compared to males (28.9%). In fact, our overweight and obese patients experienced a worse outcome compared to the normal weight patients. The higher absolute baseline PASI was statistically associated with the higher PASI percentage response for PASI-75 and 90 at week 16, as recently reported for TNF-α, IL12-23 and IL-17 inhibitors.4 As in clinical trials,5 risankizumab showed no significant safety signals, with only one patient developing upper respiratory tract infection, without discontinuation of treatment. None of our patients was infected with SARS-COV2, including the three patients having contact with infected subjects. Further investigations are needed to specify the management of patients treated with risankizumab during COVID-19 pandemic. In fact, our study was conducted during the first 4 months of pandemic in Central Italy, where SARS-CoV-2 infection incidence was considerably lower than in Northern Italy,6 and to date studies regarding the management of biologic therapies during COVID-19 emergency are rare.7 Prof. K. Hansel reports personal fees from Abbvie, personal fees from Celgene, outside the submitted work. Dr. A. Zangrilli reports personal fees from ELI LILLY, personal fees from Abbvie, outside the submitted work. Prof. L. Bianchi reports personal fees from LEO PHARMA, personal fees from Janssen-Cilag, personal fees from Abbvie, personal fees from Novartis, personal fees from Pfizer, personal fees from UCB Pharma, outside the submitted work. Prof. K. Peris reports personal fees from Leo Pharma, personal fees from Janssen, personal fees from ABBVIE, personal fees from Fresenius Kabi, personal fees from Aalmiorall, personal fees from Lilly, personal fees from Novartis, personal fees from biogen, personal fees from Sanofi, personal fees from Celgene, personal fees from Galderma, personal fees from Pierre Fabre, personal fees from Sandoz, personal fees from Sun Pharma, outside the submitted work. Dr. A. Chiricozzi reports personal fees from Leo Pharma, personal fees from Janssen, personal fees from Abbvie, personal fees from Fresenius Kabi, personal fees from Almirall, personal fees from Lilly, personal fees from Novartis, personal fees from UCB Pharma, personal fees from Biogen, personal fees from Sanofi, outside the submitted work. Prof. A. Offidani, Dr. F. Diotallevi, Dr. G. Gualdi, Dr. L. Bianchi have nothing to disclose. Prof. M.C. Fargnoli reports grants and personal fees from Almirall, grants and personal fees from Leo Pharma, personal fees from Janssen, grants and personal fees from Novartis, personal fees from Lilly, personal fees from UCB, grants and personal fees from Abbvie, personal fees from Amgen, personal fees from Pierre Fabre, grants and personal fees from Galderma, personal fees from Mylan, personal fees from Medac Pharma, personal fees from Roche, personal fees from Sun Pharma, personal fees from MSD, grants and personal fees from Sanofi-Genzyme, outside the submitted work. Dr. M. Esposito reports personal fees from Celgene, personal fees from Leo Pharma, personal fees from Janssen, personal fees from Novartis, personal fees from Eli Lilly, personal fees from UCB, personal fees from Abbvie, personal fees from Sanofi-Genzyme, personal fees from Almirall, outside the submitted work. Prof. P. Amerio reports personal fees from Eli Lilly, personal fees from Novartis, personal fees from Abbvie, personal fees from Celgene, personal fees from Sanofi, outside the submitted work. Prof. L. Stingeni reports personal fees from Janssen, personal fees from Abbvie, personal fees from Celgene, personal fees from Lilly, personal fees from Novartis, personal fees from Sanofi, outside the submitted work. The article has not been previously published and is not currently submitted elsewhere. No funding sources.