R G Langley1, K Papp2, M Gooderham3, L Zhang4, C Mallinckrodt4, N Agada4, A Blauvelt5, P Foley6, P Polzer4. 1. Dalhousie University, Halifax, NS, Canada. 2. K. Papp Clinical Research and Probity Medical Research, Waterloo, ON, Canada. 3. SkiN Centre for Dermatology and Probity Medical Research, Peterborough, Queens University, Kingston, ON, Canada. 4. Eli Lilly and Company, Indianapolis, IN, U.S.A. 5. Oregon Medical Research Center, Portland, OR, U.S.A. 6. Skin Cancer Foundation and Probity Medical Research, Carlton, VIC, Australia.
Abstract
BACKGROUND:Ixekizumab is an interleukin-17A antagonist approved for treatment of moderate-to-severe plaque psoriasis with a recommended 160-mg starting dose, then 80 mg every 2 weeks (Q2W) to week 12, and every 4 weeks (Q4W) thereafter. OBJECTIVE: To evaluate continuous Q2W dosing over 52 weeks. METHODS: In this phase III, multicentre, double-blinded, parallel-group trial, three ixekizumab dosing regimens were assessed for efficacy and safety at week 52 in patients with moderate-to-severe plaque psoriasis randomized at a 2 : 1 : 1 ratio to continuous Q2W (n = 611), continuous Q4W (n = 310) or dose adjustment per protocol (Q4W/Q2W, n = 306), each with a 160-mg starting dose. Dose adjustment was determined by predefined criteria to which investigators were blinded; 72 (23?5%) patients in the Q4W/Q2W group adjusted dose. Efficacy outcomes were evaluated using logistic regression. RESULTS: Co-primary end points were met at week 52: Psoriasis Area and Severity Index 75 responses for Q2W and Q4W dose groups were 85·9% and 79·0%, respectively (P = 0·006), and static patient global assessment 0/1 responses for Q2W and Q4W dose groups were 78·6% and 70·6%, respectively (P = 0·005). Treatment-emergent and serious adverse events were comparable across dose groups. CONCLUSIONS:Ixekizumab Q2W had higher efficacy at week 52 than ixekizumab Q4W, with no increase in safety events.
RCT Entities:
BACKGROUND:Ixekizumab is an interleukin-17A antagonist approved for treatment of moderate-to-severe plaque psoriasis with a recommended 160-mg starting dose, then 80 mg every 2 weeks (Q2W) to week 12, and every 4 weeks (Q4W) thereafter. OBJECTIVE: To evaluate continuous Q2W dosing over 52 weeks. METHODS: In this phase III, multicentre, double-blinded, parallel-group trial, three ixekizumab dosing regimens were assessed for efficacy and safety at week 52 in patients with moderate-to-severe plaque psoriasis randomized at a 2 : 1 : 1 ratio to continuous Q2W (n = 611), continuous Q4W (n = 310) or dose adjustment per protocol (Q4W/Q2W, n = 306), each with a 160-mg starting dose. Dose adjustment was determined by predefined criteria to which investigators were blinded; 72 (23?5%) patients in the Q4W/Q2W group adjusted dose. Efficacy outcomes were evaluated using logistic regression. RESULTS: Co-primary end points were met at week 52: Psoriasis Area and Severity Index 75 responses for Q2W and Q4W dose groups were 85·9% and 79·0%, respectively (P = 0·006), and static patient global assessment 0/1 responses for Q2W and Q4W dose groups were 78·6% and 70·6%, respectively (P = 0·005). Treatment-emergent and serious adverse events were comparable across dose groups. CONCLUSIONS:Ixekizumab Q2W had higher efficacy at week 52 than ixekizumab Q4W, with no increase in safety events.
Authors: Laura M Sawyer; Kinga Malottki; Celia Sabry-Grant; Najeeda Yasmeen; Emily Wright; Anne Sohrt; Emma Borg; Richard B Warren Journal: PLoS One Date: 2019-08-14 Impact factor: 3.240
Authors: R Oliver; J G Krueger; S Glatt; P Vajjah; C Mistry; M Page; H Edwards; S Garcet; X Li; B Dizier; A Maroof; M Watling; A El Baghdady; D Baeten; L Ionescu; S Shaw Journal: Br J Dermatol Date: 2021-12-27 Impact factor: 11.113