Federico Diotallevi1, Anna Campanati1, Giulia Radi2, Elisa Molinelli1, Annamaria Offidani1. 1. Clinic of Dermatology, Department of Clinical and Molecular Sciences, Marche Polytechnic University, Ancona, Italy. 2. Clinic of Dermatology, Department of Clinical and Molecular Sciences, Marche Polytechnic University, Ancona, Italy - radigiu1@gmail.com.
Abstract
BACKGROUND: Data concerning clinical experience in real world setting with ixekizumab for psoriasis are still exiguous. So, the aim of this report was to provide our experience in the use of ixekizumab in outpatient setting. METHODS: Fifteen Caucasian individuals (10 male, 5 females; mean age: 58.1; range: 30-75 years) affected by moderate to severe plaque psoriasis (PASI≥10 and/or DLQI≥10 and/or BSA≥10) were treated with ixekizumab, following dosing regimen of technical data sheet and clinically evaluated after 4 weeks (T4) and 12 weeks (T12) after. At baseline median PASI was 16.3 (range: 10-30, SD=6.0). The median BSA was 21.3 (10-35, SD=7.0), the median PGA was 3.4 (2-6, SD=1.2), the median DLQI was 18.6 (14-25, SD=3.6), the median m-NAPSI was 42.0 (30-56, SD=13.11). The median absolute value of PASI, BSA, PGA, DLQI and m-NAPSI showed a statistically significant decrease (P<0.05) already after 4 weeks of treatment, in order to testify treatment effectiveness. RESULTS: At T4, 93.3% of the patients reached PASI50, 6.9% reached PASI75; at T12, 100% of the patients reached PASI50, 80% reached PASI75, 13% reached PASI90 and 6.9% reached PASI100. One-third of observed patients reached MDA after 12 weeks of treatment. Injection site reactions were the only side effects occurring during the first 12 weeks of treatment. CONCLUSIONS: Our preliminary results seem to confirm the efficacy and safety profile provided through the UNCOVER pivotal trials (UNCOVER 1-3) although further larger observational studies are needed.
BACKGROUND: Data concerning clinical experience in real world setting with ixekizumab for psoriasis are still exiguous. So, the aim of this report was to provide our experience in the use of ixekizumab in outpatient setting. METHODS: Fifteen Caucasian individuals (10 male, 5 females; mean age: 58.1; range: 30-75 years) affected by moderate to severe plaque psoriasis (PASI≥10 and/or DLQI≥10 and/or BSA≥10) were treated with ixekizumab, following dosing regimen of technical data sheet and clinically evaluated after 4 weeks (T4) and 12 weeks (T12) after. At baseline median PASI was 16.3 (range: 10-30, SD=6.0). The median BSA was 21.3 (10-35, SD=7.0), the median PGA was 3.4 (2-6, SD=1.2), the median DLQI was 18.6 (14-25, SD=3.6), the median m-NAPSI was 42.0 (30-56, SD=13.11). The median absolute value of PASI, BSA, PGA, DLQI and m-NAPSI showed a statistically significant decrease (P<0.05) already after 4 weeks of treatment, in order to testify treatment effectiveness. RESULTS: At T4, 93.3% of the patients reached PASI50, 6.9% reached PASI75; at T12, 100% of the patients reached PASI50, 80% reached PASI75, 13% reached PASI90 and 6.9% reached PASI100. One-third of observed patients reached MDA after 12 weeks of treatment. Injection site reactions were the only side effects occurring during the first 12 weeks of treatment. CONCLUSIONS: Our preliminary results seem to confirm the efficacy and safety profile provided through the UNCOVER pivotal trials (UNCOVER 1-3) although further larger observational studies are needed.