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
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 U...
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| Published in: | Journal of the European Academy of Dermatology and Venereology Vol. 31; no. 9; pp. 1483 - 1490 |
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| Main Authors: | , , , , , , , |
| Format: | Journal Article |
| Language: | English |
| Published: |
England
01-09-2017
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| Subjects: | |
| Online Access: | Get full text |
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| Summary: | 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. |
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| Bibliography: | C. Leonardi is a consultant for AbbVie, Amgen, Boehringer Ingelheim, Dermira, Janssen, Eli Lilly and Company, Leo, Sandoz, UCB, Pfizer and Vitae. He has been an investigator for Actavis, AbbVie, Amgen, Boehringer Ingelheim, Celgene, Coherus, Corrona, Dermira, Eli Lilly and Company, Galderma, Janssen, Merck, Pfizer, Sandoz, Stiefel, LEO Pharma, Novartis and Wyeth. He is on the speaker bureaus for AbbVie, Celgene, Novartis and Eli Lilly and Company. M. Augustin has served as consultant to or paid speaker for clinical trials sponsored by companies that manufacture drugs used for the treatment of psoriasis, including AbbVie, Almirall, Amgen, Biogen, Boehringer Ingelheim, Celgene, Centocor, Eli Lilly and Company, GSK, Janssen‐Cilag, LEO Pharma, Medac, Merck, MSD, Novartis, Pfizer, UCB and Xenoport. Funding sources A. Blauvelt has served as a scientific consultant and a paid speaker for Eli Lilly and Company. He has also received funds to perform clinical studies for Eli Lilly and Company. He has served as a scientific advisor and clinical study investigator for AbbVie, Amgen, Boehringer Ingelheim, Celgene, Dermira, Genentech, GlaxoSmithKline, Janssen, Merck, Novartis, Pfizer, Regeneron, Sandoz, Sanofi Genzyme, Sun Pharma, UCB and Valeant. H.L. Sofen has been a paid consultant and clinical investigator by/for Eli Lilly and Company. He is an investigator and consultant for Novartis, Janssen, Celgene, Pfizer, Amgen, Sun Pharma, Merck, AbbVie and Boehringer Ingelheim. K. Reich served or serves on advisory boards of/was or is a speaker for/was or is an author for/was or is an investigator for/was or is a consultant for AbbVie, Janssen‐Cilag, LEO Pharma and Eli Lilly and Company. He served or serves on advisory boards of/was or is a speaker for/was or is an author for/was or is an investigator for Celgene and Novartis. He served or serves on advisory boards and was or is an author, investigator and consultant for Forward Pharma and UCB. He served on advisory boards and was an investigator for Amgen. He served on advisory boards of and was an author and investigator for Biogen. He served on advisory boards of, and was an investigator and consultant for Boehringer Ingelheim. He was a speaker, investigator and consultant for Covagen. He was an author and investigator for GlaxoSmithKline. He was a speaker, author and investigator for Medac. He was a speaker and investigator for Merck, Sharp and Dohme. He served on advisory boards for Pfizer. He served on advisory boards and was an investigator for Regeneron. He served on advisory boards and consulted for Xenoport. He served on advisory boards and was an investigator for Takeda. He received personal compensation for advisory boards, speaking and consulting from SCIderm. Otherwise he received honoraria for advisory boards, speaking and consulting and received study fees for serving as an investigator. He reports being a patent/stockholder for Forward Pharma. M. Gooderham gave CME presentations and served on advisory boards for Abbott/AbbVie, Amgen, Astellas, Graceway, Janssen, LEO Pharma and Novartis. She gave CME presentations and received consulting fees from Eli Lilly and Company. She participated in advisory boards and received consulting fees from Boehringer Ingelheim and Sanofi Genzyme. She gave CME presentations for Actelion and Galderma and participated on advisory boards for Pfizer. She participated in clinical trials for AbbVie, Amgen, Boehringer Ingelheim, Celgene, Dermira, Dr. Reddy's Laboratories, Eli Lilly and Company, Forward Pharma, Galderma, Janssen, Kyowa Hakko Kirin, Kythera, LEO Pharma, MedImmune, Novartis, Pfizer, Sanofi Genzyme, Regeneron and Roche. This work was funded by Eli Lilly and Company. R. Burge and B. Zhu are full‐time employees of Eli Lilly and Company and own stock. Eli Lilly and Company Conflict of Interest and Disclosures ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 ObjectType-News-3 content type line 23 |
| ISSN: | 0926-9959 1468-3083 |
| DOI: | 10.1111/jdv.14211 |