PMID- 31786732 OWN - NLM STAT- MEDLINE DCOM- 20210329 LR - 20210329 IS - 1179-1888 (Electronic) IS - 1175-0561 (Linking) VI - 21 IP - 3 DP - 2020 Jun TI - Ixekizumab Effectiveness and Safety in the Treatment of Moderate-to-Severe Plaque Psoriasis: A Multicenter, Retrospective Observational Study. PG - 441-447 LID - 10.1007/s40257-019-00490-2 [doi] AB - BACKGROUND: Ixekizumab (anti-IL-17A) is a biological agent used for the treatment of moderate-to-severe psoriasis. Real-life data on the effectiveness and safety of ixekizumab are currently scarce. OBJECTIVE: The objective of this study was to evaluate the effectiveness and safety of ixekizumab in a cohort of psoriatic and psoriatic arthritis patients. METHODS: We conducted a retrospective study involving 201 patients affected by moderate-to-severe psoriasis and treated with ixekizumab at seven Italian University centers. Data analysis focused on 110 patients who started ixekizumab at baseline and completed at least 24 weeks of treatment. RESULTS: Significant reduction of mean (+/- standard deviation) baseline Psoriasis Area Severity Index (PASI) score (14.3 +/- 5.8) was detected at 4 weeks of ixekizumab therapy (4.9 +/- 4.2, p < 0.001), with a further significant improvement at weeks 12 and 24 (1.9 +/- 2.9 and 0.9 +/- 1.6, respectively) (p < 0.001). Our analysis showed 90%, 72%, and 57% of patients achieving PASI 75, 90, and 100 responses (75%, 90%, and 100% reduction in PASI score), respectively, after 24 weeks' therapy. For patients with arthritis (28%), a significant reduction in the mean (+/- standard deviation) baseline Disease Activity Score (DAS)-28 score (4.6 +/- 5.1) was detected at week 4 (2.5 +/- 3.9, p < 0.01), with a further significant improvement at weeks 12 and 24 (2.1 +/- 1.2 and 1.4 +/- 0.9, respectively) (p < 0.001). The bio-naive group showed significantly higher PASI 90 and 100 response rates at week 12 than the bio-exposed one (p < 0.05). This trend in terms of PASI 100 response was also maintained at week 24 (p < 0.05). Furthermore, PASI 90 responses were significantly higher in anti-interleukin (IL)-17A-naive patients at week 24 than in anti-IL-17A-experienced ones (p < 0.05). The dropout rate for adverse events (AEs) was as low as 2% (2/110), while AEs that did not cause treatment interruption were observed in 6% (7/110). Patients withdrawing from the study were defined as non-responders according to the non-responder imputation method. The retrospective design of the study does not allow missing data to be retrieved or homogeneous patient selection. CONCLUSIONS: The present study illustrates ixekizumab in real-world clinical practice, confirming its usefulness and safety in the management of psoriasis and psoriatic arthritis. FAU - Chiricozzi, Andrea AU - Chiricozzi A AD - Institute of Dermatology, Catholic University, Rome, Italy. AD - Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy. FAU - Burlando, Martina AU - Burlando M AD - Section of Dermatology, Di.S.Sal. Department of Health Science, San Martino Polyclinic Hospital, University of Genoa, Genoa, Italy. FAU - Caldarola, Giacomo AU - Caldarola G AD - Institute of Dermatology, Catholic University, Rome, Italy. AD - Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy. FAU - Conti, Andrea AU - Conti A AD - Department of Dermatology, University of Modena and Reggio Emilia, Modena, Italy. FAU - Damiani, Giovanni AU - Damiani G AD - Clinical Dermatology, IRCCS, Istituito Ortopedico Galeazzi, Milan, Italy. FAU - De Simone, Clara AU - De Simone C AD - Institute of Dermatology, Catholic University, Rome, Italy. AD - Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy. FAU - Dini, Valentina AU - Dini V AD - Dermatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy. FAU - Malagoli, Piergiorgio AU - Malagoli P AD - Dermatology Unit, Azienda Ospedaliera San Donato Milanese, Milan, Italy. FAU - Peccerillo, Francesca AU - Peccerillo F AD - Department of Dermatology, University of Modena and Reggio Emilia, Modena, Italy. FAU - Potenza, Concetta AU - Potenza C AD - Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Polo Pontino, Italy. FAU - Scala, Emanuele AU - Scala E AD - Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy. FAU - Skroza, Nevena AU - Skroza N AD - Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Polo Pontino, Italy. FAU - Balato, Anna AU - Balato A AUID- ORCID: 0000-0001-5485-0172 AD - Department of Advanced Biomedical Sciences, University of Naples Federico II, Via Pansini 5, 80131, Naples, Italy. annabalato@yahoo.it. LA - eng PT - Journal Article PT - Multicenter Study PT - Observational Study PL - New Zealand TA - Am J Clin Dermatol JT - American journal of clinical dermatology JID - 100895290 RN - 0 (Antibodies, Monoclonal, Humanized) RN - 0 (IL17A protein, human) RN - 0 (Interleukin-17) RN - BTY153760O (ixekizumab) SB - IM MH - Adult MH - Antibodies, Monoclonal, Humanized/*administration & dosage/adverse effects MH - Female MH - Humans MH - Interleukin-17/antagonists & inhibitors/immunology MH - Italy MH - Male MH - Middle Aged MH - Pragmatic Clinical Trials as Topic MH - Psoriasis/diagnosis/*drug therapy/immunology MH - Retrospective Studies MH - Severity of Illness Index MH - Treatment Outcome EDAT- 2019/12/02 06:00 MHDA- 2021/03/30 06:00 CRDT- 2019/12/02 06:00 PHST- 2019/12/02 06:00 [pubmed] PHST- 2021/03/30 06:00 [medline] PHST- 2019/12/02 06:00 [entrez] AID - 10.1007/s40257-019-00490-2 [pii] AID - 10.1007/s40257-019-00490-2 [doi] PST - ppublish SO - Am J Clin Dermatol. 2020 Jun;21(3):441-447. doi: 10.1007/s40257-019-00490-2.