<p> BACKGROUND: Injection-site reactions (ISRs) are reported with biologic therapies. The objective of this study was to comprehensively characterize ISRs among moderate-to-severe psoriasis patients treated with ixekizumab, a high-affinity monoclonal antibody that selectively targets interleukin (IL)-17A.</p> <p> METHODS: ISRs are presented from UNCOVER-1, UNCOVER-2, and UNCOVER-3 (12 weeks) and all ixekizumab-exposed patients in 11 controlled and uncontrolled trials (156 weeks).</p> <p> RESULTS: At week 12, reported ISR frequency with 80 mg ixekizumab every 2 weeks (IXE Q2W, 16.8%) was comparable with etanercept twice weekly (16.4%); both were significantly higher than placebo (3.3%). With IXE Q2W, ISRs were mild (12.3%), moderate (3.9%), or severe (0.7%), typically reported in the first 2 weeks (median onset, 6.6 days), and most commonly characterized as nonspecified, erythema, and pain. Generally, erythema onset was delayed, whereas pain occurred around drug administration. Discontinuation from ixekizumab due to ISRs (0.4%) occurred in the first 12 weeks. After 2 weeks, ISR frequency decreased and remained stable (≤4.2%) through week 156. No ISR-related serious adverse events were reported in ixekizumab-treated patients. ISR data were solicited if patients reported injection-associated events. Since nonspecified ISR was the most commonly reported term, specific types might be underreported.</p> <p> CONCLUSIONS: ISRs have been reported with ixekizumab during clinical trials. These reactions are typically tolerable, manageable, and decrease over time.</p> <p>Clinicaltrials.gov: NCT01474512 (UNCOVER-1); NCT01597245 (UNCOVER-2); NCT01646177 (UNCOVER-3); NCT01777191 (UNCOVER-A); NCT01624233 (UNCOVER-J); NCT01107457 (I1F-MC-RHAJ); NCT02561806 (I1F-MC-RHBS); NCT02387801 (I1F-US-RHBO);NCT02513550 (I1F-MC-RHBP); NCT02634801 (I1F-EW-RHBZ)</p> <p>J Drugs Dermatol. 2018;17(2):200-206.</p> <p>THIS ARTICLE HAD BEEN MADE AVAILABLE FREE OF CHARGE.</p> <p>PLEASE SCROLL DOWN TO ACCESS THE FULL TEXT OF THIS ARTICLE WITHOUT LOGGING IN.</p> <p>NO PURCHASE NECESSARY.</p> <p>PLEASE CONTACT THE PUBLISHER WITH ANY QUESTIONS.</p>.
<p> BACKGROUND: Injection-site reactions (ISRs) are reported with biologic therapies. The objective of this study was to comprehensively characterize ISRs among moderate-to-severe psoriasispatients treated with ixekizumab, a high-affinity monoclonal antibody that selectively targets interleukin (IL)-17A.</p> <p> METHODS: ISRs are presented from UNCOVER-1, UNCOVER-2, and UNCOVER-3 (12 weeks) and all ixekizumab-exposed patients in 11 controlled and uncontrolled trials (156 weeks).</p> <p> RESULTS: At week 12, reported ISR frequency with 80 mg ixekizumab every 2 weeks (IXE Q2W, 16.8%) was comparable with etanercept twice weekly (16.4%); both were significantly higher than placebo (3.3%). With IXE Q2W, ISRs were mild (12.3%), moderate (3.9%), or severe (0.7%), typically reported in the first 2 weeks (median onset, 6.6 days), and most commonly characterized as nonspecified, erythema, and pain. Generally, erythema onset was delayed, whereas pain occurred around drug administration. Discontinuation from ixekizumab due to ISRs (0.4%) occurred in the first 12 weeks. After 2 weeks, ISR frequency decreased and remained stable (≤4.2%) through week 156. No ISR-related serious adverse events were reported in ixekizumab-treated patients. ISR data were solicited if patients reported injection-associated events. Since nonspecified ISR was the most commonly reported term, specific types might be underreported.</p> <p> CONCLUSIONS: ISRs have been reported with ixekizumab during clinical trials. These reactions are typically tolerable, manageable, and decrease over time.</p> <p>Clinicaltrials.gov: NCT01474512 (UNCOVER-1); NCT01597245 (UNCOVER-2); NCT01646177 (UNCOVER-3); NCT01777191 (UNCOVER-A); NCT01624233 (UNCOVER-J); NCT01107457 (I1F-MC-RHAJ); NCT02561806 (I1F-MC-RHBS); NCT02387801 (I1F-US-RHBO);NCT02513550 (I1F-MC-RHBP); NCT02634801 (I1F-EW-RHBZ)</p> <p>J Drugs Dermatol. 2018;17(2):200-206.</p> <p>THIS ARTICLE HAD BEEN MADE AVAILABLE FREE OF CHARGE.</p> <p>PLEASE SCROLL DOWN TO ACCESS THE FULL TEXT OF THIS ARTICLE WITHOUT LOGGING IN.</p> <p>NO PURCHASE NECESSARY.</p> <p>PLEASE CONTACT THE PUBLISHER WITH ANY QUESTIONS.</p>.
Authors: April Armstrong; Carle Paul; Luis Puig; Wolf Henning Boehncke; Michael Freeman; Hideshi Torii; Kim Papp; Christopher E M Griffiths; Andrew Blauvelt; Kristian Reich; Melinda Gooderham; Tadashi Terui; Lisa Renda; Noah Agada; Wen Xu; Gaia Gallo; Mark G Lebwohl Journal: Dermatol Ther (Heidelb) Date: 2019-11-20
Authors: Vinod Chandran; Désirée van der Heijde; Roy M Fleischmann; Eric Lespessailles; Philip S Helliwell; Hideto Kameda; Ruben Burgos-Vargas; Janelle S Erickson; Suchitrita S Rathmann; Aubrey Trevelin Sprabery; Julie A Birt; Catherine L Shuler; Gaia Gallo Journal: Rheumatology (Oxford) Date: 2020-10-01 Impact factor: 7.580
Authors: Ana-Maria Orbai; Jordi Gratacós; Anthony Turkiewicz; Stephen Hall; Eva Dokoupilova; Bernard Combe; Peter Nash; Gaia Gallo; Clinton C Bertram; Amanda M Gellett; Aubrey Trevelin Sprabery; Julie Birt; Lisa Macpherson; Vladimir J Geneus; Arnaud Constantin Journal: Rheumatol Ther Date: 2020-12-05