Patient-reported outcomes of adalimumab, phototherapy, and placebo in the Vascular Inflammation in Psoriasis Trial: A randomized controlled study - 12/09/19
, Marilyn T. Wan, MBChB, MPH a, Daniel B. Shin, PhD a, April W. Armstrong, MD, MPH b, Kristina Callis Duffin, MD, MS c, Zelma C. Chiesa Fuxench, MD MSCE a, Robert E. Kalb, MD d, Alan Menter, MD e, Eric L. Simpson, MD f, Junko Takeshita, MD, PhD, MSCE a, g, Stephen K. Tyring, MD h, Abby S. Van Voorhees, MD i, Nehal N. Mehta, MD, MSCE j, Joel M. Gelfand, MD, MSCE a, g, ⁎ Abstract |
Background |
There are limited data about the impact of narrowband ultraviolet B phototherapy on patient-reported measures of health-related quality of life.
Objective |
To evaluate the impact of adalimumab and phototherapy on health-related quality of life.
Methods |
We examined patient-reported outcomes from a multicenter, randomized, placebo-controlled trial (ClinicalTrials.gov no. NCT01553058). The Dermatology Life Quality Index and EQ-5D-3L were evaluated every 4 weeks.
Results |
We enrolled 97 patients: 30.9% were female, mean age was 43.5 years (standard deviation, 14.0), and median Psoriasis Area and Severity Index score was 16.7 (interquartile range, 13.9-21.6). At week 12, patients being treated with adalimumab (odds ratio [OR], 2.88; 95% confidence interval [CI], 1.02-8.17) and phototherapy (OR, 8.83; 95% CI, 2.47-31.57) were more likely to achieve the minimal clinically important difference in the Dermatology Life Quality Index compared with those receiving placebo. There were higher odds of achieving the minimal clinically important difference for the EQ-5D-3L Index score when comparing phototherapy versus placebo (OR, 9.78; 95% CI, 2.99-31.95) and phototherapy versus adalimumab (OR, 4.07; 95% CI, 1.42-11.70).
Limitations |
Small sample size, secondary analysis, generalizability.
Conclusion |
Phototherapy and adalimumab both improve skin-related quality of life and overall health-related quality of life compared with placebo in patients with psoriasis; however, patients treated with phototherapy achieved more improvement in overall health-related quality of life compared with patients treated with adalimumab.
Le texte complet de cet article est disponible en PDF.Key words : adalimumab, DLQI, EQ5D, patient-reported outcomes, phototherapy, psoriasis, randomized controlled trials
Abbreviations used : CI, DLQI, EQ-VAS, HRQoL, MCID, nbUVB, OR, PASI 75, PRO
Plan
| Drs Noe and Wan contributed equally to this article. |
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| Funding sources: Supported in part by a grant from the National Institutes of Health 5P30AR069589-03 and National Institutes of Health/National Heart, Lung, and Blood Institute R01- HL111293 (Dr Gelfand), a grant from AbbVie for Vascular Inflammation in Psoriasis (Dr Gelfand), National Institute of Arthritis and Musculoskeletal and Skin Diseases K23-AR073932 (Dr Noe), and a medical dermatology fellowship from the National Psoriasis Foundation (Dr Wan). |
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| Disclosure: Dr Armstrong has served as a research investigator or consultant to AbbVie, Janssen, Lilly, Leo, Novartis, UCB, Ortho Dermatologics, Dermira, Sanofi Genzyme, Regeneron, BMS, Dermavant, Science 37, and Modernizing Medicine. Dr Callis Duffin has served as a research investigator or consultant to Amgen, AbbVie, Celgene, Janssen, Lilly, Novartis, UCB, Ortho Dermatologic, Regeneron, BMS, Pfizer, and Stiefel. Dr Gelfand served as a consultant for BMS, Boehringer Ingelheim, GSK, Janssen Biologics, Novartis Corp, UCB (DSMB), Sanofi, and Pfizer, receiving honoraria; receives research grants (to the Trustees of the University of Pennsylvania) from AbbVie, Janssen, Novartis Corp, Celgene, Ortho Dermatologics, and Pfizer; received payment for continuing medical education work related to psoriasis that was supported indirectly by Lilly, Ortho Dermatologic, and Novartis; is a co-patent holder of resiquimod for treatment of cutaneous T-cell lymphoma; and is a deputy editor for the Journal of Investigative Dermatology, receiving honoraria from the Society for Investigative Dermatology. Dr Kalb has received grants/research funding from AbbVie, Amgen, Boehringer Ingelheim, Janssen-Ortho, Merck & Co, and Novartis Pharmaceuticals Corp over the last 24 months; during this time frame, he has also served as a consultant and received honoraria for Dermira, Janssen-Ortho, and Sun Pharmaceutical Industries Ltd and a DSMB member honoraria for Eli Lilly and Co. Dr. Mehta is a full-time US government employee and receives research grants to the National Heart, Lung, and Blood Institute from AbbVie, Janssen, Celgene, and Novartis and serves on the medical board of the National Psoriasis Foundation and is associate editor of the Journal of Translational Medicine. Dr Menter in the last 24 months has served on the advisory board for AbbVie, Allergan, Amgen, Boehringer Ingelheim, Eli Lilly, Janssen Biotech, and LEO Pharma; has worked as a consultant for AbbVie, Allergan, Amgen, Eli Lilly, Galderma, Janssen Biotech, LEO Pharma, Novartis, Pfizer, Vitae, and Xenoport; has acted as an investigator for AbbVie, Allergan, Amgen, Anacor, Boehringer Ingelheim, Celgene, Dermira, Eli Lilly, Janssen Biotech, LEO Pharma, Merck, Neothetics, Novartis, Pfizer, Regeneron, Symbio/Maruho, and Xenoport; serves as a speaker for AbbVie, Amgen, Janssen Biotech, and LEO Pharma; has received compensation in the form of grants from AbbVie, Allergan, Amgen, Anacor, Boehringer Ingelheim, Celgene, Dermira, Janssen Biotech, LEO Pharma, Merck, Neothetics, Novartis, Pfizer, Regeneron, Symbio/Maruho, and Xenoport; and has received honoraria from AbbVie, Allergan, Amgen, Boehringer Ingelheim, Eli Lilly, Galderma, Janssen Biotech, LEO Pharma, Novartis, Pfizer, Vitae, and Xenoport. Dr Simpson has served as a consultant for AbbVie, Anacor, Celgene, Dermira, Genentech, Leo, GlaxoSmithKline, Pfizer, Regeneron, Sanofi-Genzyme, Menlo, and Eli Lilly in the last 24 months and has acted as the primary investigator for the following sponsored trials: Anacor, Celgene, Chugai, Dermira, Eli Lilly, Genentech, MedImmune, Merck, Novartis, Regeneron, Roivant, Tioga, and Vanda. Dr Takeshita receives a research grant from Pfizer (to the Trustees of the University of Pennsylvania) and has received payment for continuing medical education work related to psoriasis that was supported indirectly by Eli Lilly. Dr Tyring conducts clinical studies sponsored by the following companies: AbbVie/BI, Celgene, Coherus, Dermira, Eli Lilly, Janssen, Leo, Merck, Novartis, Pfizer, Regeneron/Sanofi, and Valeant and is a speaker for AbbVie, Eli Lilly, Janssen, Leo, Novartis, Pfizer, Regeneron/Sanofi, and Valeant. Dr Van Voorhees has served on the advisory board of Celgene, Dermira, Allergan, Merck, Pfizer, Aqua, AstraZeneca, Janssen, Amgen, Leo, Allergan, and Lilly; acts as a consultant and serves on the board for Novartis and AbbVie; and has received a portion of ex-spouse pension from Merck. Drs Chiesa Fuxench, Noe, Shin, and Wan have no conflicts of interest to declare. |
Vol 81 - N° 4
P. 923-930 - octobre 2019 Retour au numéro
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