Abstract
To evaluate ixekizumab safety in adults with psoriatic arthritis (PsA). Safety data from 2 integrated data sets are presented: 1) 24-week, double-blind, placebo-controlled period of SPIRIT-P1 and SPIRIT-P2; and 2) all ixekizumab-treated patients of SPIRIT-P1 and SPIRIT-P2 plus SPIRIT-P3 open-label period. We report adverse event (AE) frequency and exposure-adjusted incidence rates per 100 patient-years at 12-week intervals to week 96. The placebo-controlled period had 678 patients (safety population): 224 placebo, 229 ixekizumab every 4 weeks, and 225 ixekizumab every 2 weeks. Overall, 1,118 patients received ixekizumab (total exposure 1,373.4 patient-years). In the placebo-controlled period, the frequencies of ixekizumab-treated patients experiencing ≥1 treatment-emergent AE (TEAE) and those experiencing serious AEs were 68.1% (56.7% placebo) and 4.4% (2.7% placebo), respectively. Injection site reactions (ISRs) were very common (21.4% ixekizumab [4.5% placebo]), with ISR discontinuation rates of 1.1% (ixekizumab) and 0.4% (placebo). Through week 96, the incidence rates of ISRs decreased with increasing ixekizumab exposure. The frequencies of AEs of special interest were 32.8% (ixekizumab) and 27.7% (placebo); for serious infe...Continue Reading
References
Sep 1, 1985·The American Journal of Medicine·A WeinsteinF Farouhar
Jan 17, 2009·Annals of the Rheumatic Diseases·L C CoatesP S Helliwell
Nov 11, 2009·Infection and Immunity·Ariana Peck, Elizabeth D Mellins
Feb 26, 2011·Science·Anne PuelJean-Laurent Casanova
Jul 1, 2011·Immunologic Research·Sarah L GaffenAlanna C Peterson
Mar 1, 2012·Clinical Reviews in Allergy & Immunology·Siba P Raychaudhuri
Mar 7, 2012·Immunologic Research·Aleksandra KrsticDiana Bugarski
May 19, 2012·Gut·Wolfgang HueberUNKNOWN Secukinumab in Crohn's Disease Study Group
Sep 6, 2012·European Journal of Immunology·Sophie CypowyjAnne Puel
Dec 19, 2012·Rheumatology·Eric M Ruderman
Aug 13, 2014·Nature Reviews. Rheumatology·Onur BoymanFrançois Spertini
Oct 30, 2014·Annals of the Rheumatic Diseases·Alexis OgdieJoel M Gelfand
Dec 19, 2014·Expert Opinion on Drug Safety·Carlo SelmiYehuda Shoenfeld
Jan 30, 2015·Expert Opinion on Drug Safety·Giuseppe MurdacaFrancesco Puppo
Apr 12, 2015·Expert Opinion on Investigational Drugs·Shilan MozaffariMohammad Abdollahi
Jun 15, 2015·Lancet·Christopher E M GriffithsUNKNOWN UNCOVER-2 and UNCOVER-3 investigators
Jul 3, 2015·Lancet·Iain B McInnesUNKNOWN FUTURE 2 Study Group
Sep 26, 2015·Journal of Clinical Rheumatology : Practical Reports on Rheumatic & Musculoskeletal Diseases·Lin LiSusan Jick
Oct 1, 2015·The New England Journal of Medicine·Philip J MeaseUNKNOWN FUTURE 1 Study Group
Oct 16, 2015·Current Drug Safety·E MolinelliA Offidani
May 5, 2016·Journal of Inflammation Research·Ling LiuKristine Kikly
May 18, 2016·Journal of the American Academy of Dermatology·Peter C M van de KerkhofTodd Fox
Jun 15, 2016·The New England Journal of Medicine·Kenneth B GordonUNKNOWN UNCOVER-3 Study Group
Aug 25, 2016·Annals of the Rheumatic Diseases·Philip J MeaseUNKNOWN SPIRIT-P1 Study Group
Nov 28, 2016·Journal of the American Academy of Dermatology·Bruce StroberKristian Reich
May 30, 2017·Lancet·Peter NashUNKNOWN SPIRIT-P2 Study Group
Citations
Dec 28, 2018·Expert Review of Clinical Immunology·Christoffer BlegvadClaus Zachariae
Feb 12, 2019·Journal of Cutaneous Medicine and Surgery·Charles W LyndeGordon E Searles
Nov 16, 2019·The Journal of Experimental Medicine·Pascale ZwickyBurkhard Becher
Dec 25, 2019·Expert Opinion on Drug Safety·Lluís Puig
May 26, 2020·Rheumatology·Mark C GenoveseMark G Lebwohl
Aug 27, 2019·Frontiers in Pharmacology·Lazaros I SakkasDimitrios P Bogdanos
Jan 23, 2020·Arthritis Research & Therapy·Bernard CombeMark C Genovese
Mar 25, 2020·American Journal of Clinical Dermatology·Alice GottliebAbby Jacobson
Sep 15, 2020·Frontiers in Pharmacology·Colleen S CurranJeffrey B Kopp
Sep 5, 2020·Paediatric Drugs·John M Bridges, Matthew L Stoll
Sep 29, 2020·Frontiers in Immunology·Mohamed A AlfalehAnwar M Hashem
Nov 16, 2019·Arthritis & Rheumatology·Julia ManassonJose U Scher
Jul 3, 2020·Therapeutic Advances in Musculoskeletal Disease·Gerasimos EvangelatosGeorge E Fragoulis
Sep 17, 2020·Rheumatology and Therapy·Linda L Grinnell-MerrickWilliam Saalfeld
Nov 11, 2020·Immunotherapy·Eric Lespessailles, Hechmi Toumi
Dec 6, 2020·Rheumatology and Therapy·Ana-Maria OrbaiArnaud Constantin
Jan 28, 2021·Arthritis Research & Therapy·Bernard CombePeter Nash
Dec 10, 2019·Lancet·Atul DeodharUNKNOWN COAST-X Study Group
Mar 20, 2019·Journal of the American Academy of Dermatology·Emily BaumrinJoseph F Merola
Dec 12, 2020·Actas dermo-sifiliográficas·B Pinilla MartínR Rivera Díaz
May 2, 2021·Reumatología clinica·Julio Casasola-VargasCésar Pacheco-Tena
Apr 26, 2020·Annals of the Rheumatic Diseases·Julia ManassonJose U Scher
Jun 12, 2020·Journal of the American Academy of Dermatology·Ulrich MrowietzMark G Lebwohl
Jul 27, 2021·Reumatología Clinica·Julio Casasola-VargasCésar Pacheco-Tena
Mar 9, 2021·Arthritis & Rheumatology·Laura C CoatesUNKNOWN SPIRIT-P3 Study Group
Aug 28, 2021·Rheumatology and Therapy·Steven L TruongPhilip C Robinson
Apr 9, 2021·The British Journal of Dermatology·M LebwohlP J Mease
May 3, 2021·The Journal of Rheumatology·Proton RahmanIain B McInnes