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Efficacy and safety of continuous every‐2‐week dosing of ixekizumab over 52 weeks in patients with moderate‐to‐severe plaque psoriasis in a randomized phase III trial ( IXORA ‐P)
Author(s) -
Langley R.G.,
Papp K.,
Gooderham M.,
Zhang L.,
Mallinckrodt C.,
Agada N.,
Blauvelt A.,
Foley P.,
Polzer P.
Publication year - 2018
Publication title -
british journal of dermatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.304
H-Index - 179
eISSN - 1365-2133
pISSN - 0007-0963
DOI - 10.1111/bjd.16426
Subject(s) - ixekizumab , dosing , medicine , psoriasis , adverse effect , plaque psoriasis , psoriasis area and severity index , randomized controlled trial , dermatology , secukinumab , psoriatic arthritis
Summary 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.