C L Leonardi1, A Blauvelt2, H L Sofen3, M Gooderham4, M Augustin5, R Burge6,7, B Zhu6, K Reich8. 1. Central Dermatology, St Louis, MO, USA. 2. Oregon Medical Research Center, Portland, OR, USA. 3. Department of Medicine (Dermatology), David Geffen School of Medicine, Los Angeles, CA, USA. 4. SKiN Centre for Dermatology and Queen's University, Peterborough, ON, Canada. 5. Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg, Hamburg, Germany. 6. Eli Lilly and Company, Indianapolis, IN, USA. 7. University of Cincinnati, Cincinnati, OH, USA. 8. Dermatologikum Hamburg and SCIderm Research Institute, Hamburg, Germany.
Abstract
BACKGROUND:Patients with moderate-to-severe psoriasis report impaired health-related quality of life (HRQoL). OBJECTIVE: To assess speed of onset of ixekizumab-induced clinically relevant improvement in HRQoL. 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 (IXEQ2W), 80 mg ixekizumab every 4 weeks (IXEQ4W), 50 mg etanercept (ETN) twice weekly or placebo (PBO) for 12 weeks. HRQoL 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 IXEQ4W and 736 IXEQ2W. Significantly greater differences in time to DLQI ≥5 point or Itch NRS ≥4 point improvement for IXEQ2W or IXEQ4W 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 MCIDs 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 HRQoL and itch compared with patients treated with ETN and PBO.
RCT Entities:
BACKGROUND:Patients with moderate-to-severe psoriasis report impaired health-related quality of life (HRQoL). OBJECTIVE: To assess speed of onset of ixekizumab-induced clinically relevant improvement in HRQoL. 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 (IXEQ2W), 80 mg ixekizumab every 4 weeks (IXEQ4W), 50 mg etanercept (ETN) twice weekly or placebo (PBO) for 12 weeks. HRQoL 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 IXEQ4W and 736 IXEQ2W. Significantly greater differences in time to DLQI ≥5 point or Itch NRS ≥4 point improvement for IXEQ2W or IXEQ4W 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 MCIDs 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 HRQoL and itch compared with patients treated with ETN and PBO.
Authors: Gil Yosipovitch; Adam Reich; Martin Steinhoff; Anke Beselin; Toby Kent; Martin Dossenbach; Lovisa Berggren; Carsten Henneges; Thomas Luger Journal: Dermatol Ther (Heidelb) Date: 2018-11-21
Authors: A Blauvelt; K Papp; A Gottlieb; A Jarell; K Reich; C Maari; K B Gordon; L K Ferris; R G Langley; Y Tada; R G Lima; H Elmaraghy; G Gallo; L Renda; S Y Park; R Burge; J Bagel Journal: Br J Dermatol Date: 2020-01-15 Impact factor: 9.302