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Rapid improvements in health‐related quality of life and itch with ixekizumab treatment in randomized phase 3 trials: results from UNCOVER ‐2 and UNCOVER ‐3
Author(s) -
Leonardi C.L.,
Blauvelt A.,
Sofen H.L.,
Gooderham M.,
Augustin M.,
Burge R.,
Zhu B.,
Reich K.
Publication year - 2017
Publication title -
journal of the european academy of dermatology and venereology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.655
H-Index - 107
eISSN - 1468-3083
pISSN - 0926-9959
DOI - 10.1111/jdv.14211
Subject(s) - medicine , ixekizumab , dermatology life quality index , post hoc analysis , minimal clinically important difference , clinical endpoint , placebo , hazard ratio , randomization , randomized controlled trial , quality of life (healthcare) , confidence interval , pathology , disease , alternative medicine , nursing , secukinumab , psoriatic arthritis
Background Patients with moderate‐to‐severe psoriasis report impaired health‐related quality of life ( HRQ oL). Objective To assess speed of onset of ixekizumab‐induced clinically relevant improvement in HRQ oL. Methods This post hoc analysis used pooled data from patients randomized in UNCOVER ‐2 and UNCOVER ‐3, and treated with 80 mg ixekizumab every 2 weeks ( IXEQ 2W), 80 mg ixekizumab every 4 weeks ( IXEQ 4W), 50 mg etanercept ( ETN ) twice weekly or placebo ( PBO ) for 12 weeks. HRQ oL and pruritus were assessed using the Dermatology Life Quality Index ( DLQI ) and Itch Numeric Rating Scale ( NRS ), respectively. Minimally clinical important differences ( MCID ) in DLQI and Itch NRS were defined as ≥5‐point and ≥4‐point improvements from baseline, respectively. Time to response from randomization was estimated using Kaplan–Meier methodology and the log‐rank test. Hazard ratios between treatments were calculated using a Cox proportional hazards regression model adjusting for studies. Results A total of 2570 patients were included: 361 PBO ; 740 ETN ; 733 IXEQ 4W and 736 IXEQ 2W. Significantly greater differences in time to DLQI ≥5 point or Itch NRS ≥4 point improvement for IXEQ 2W or IXEQ 4W compared with ETN and PBO ( P < 0.001) were observed. The median time when 50% of patients reached a ≥5‐point reduction in DLQI was shorter for ixekizumab‐treated patients (2 weeks, both schedules) compared with ETN ‐ (4 weeks) or PBO ‐treated (>12 weeks) patients. Likewise, the median time when 50% of patients reached a ≥4‐point reduction in Itch NRS was shorter for ixekizumab‐treated patients (2 weeks, both schedules) compared with ETN ‐ (8 weeks) or PBO ‐treated (>12 weeks) patients. Significantly more ixekizumab‐treated patients were likely to achieve MCID s in DLQI or itch reduction compared with ETN or PBO after 12 weeks of treatment. Conclusion Ixekizumab‐treated patients achieved more rapid improvements both in HRQ oL and itch compared with patients treated with ETN and PBO .