The efficacy and safety of infliximab in patients with plaque psoriasis who had an inadequate response to etanercept: Results of a prospective, multicenter, open-label study - 14/09/12
Reprint requests: Marc Chevrier, MD, PhD, Janssen Biotech Inc, 800 Ridgeview Dr, Horsham, PA 19044.Abstract |
Background |
In patients with psoriasis and inadequate response (IR) to tumor necrosis factor-⍺ antagonist treatment, the incremental benefit of switching to another tumor necrosis factor-⍺ antagonist is unknown.
Objective |
We sought to evaluate the clinical response to an etanercept-to-infliximab switch in patients with psoriasis and IR to etanercept.
Methods |
Adults with moderate-to-severe plaque psoriasis and IR to etanercept (≥4 months) were eligible for this open-label study (called PSUNRISE). Patients had a Physician Global Assessment (PGA) score of at least 2 (mild) on a 5-point scale with etanercept, with or without concomitant oral systemic methotrexate or cyclosporine at baseline and during the study. Patients received intravenous infusions of infliximab 5 mg/kg at weeks 0, 2, 6, 14, and 22. PGA was used to evaluate efficacy at week 10 (primary end point) and week 26 (durability). Safety was evaluated through the end of the study.
Results |
Of 215 patients, only 10 received concomitant immunomodulators. At week 10, 65.4% of patients (138 of 211; 95% confidence interval 58.6%-71.8%) achieved a PGA score of clear (0) or minimal (1) (primary end point). This response was durable through week 26, at which time 61.3% (122 of 199; 95% confidence interval 54.2%-68.1%) achieved a PGA score of clear (0) or minimal (1). There were no unexpected side effects or safety concerns.
Limitations |
This was an open-label, 26-week study; an incremental change of 1 PGA point, even mild to minimal, was considered clinically significant, as most psoriasis practitioners seek to achieve minimal psoriasis or clear skin.
Conclusion |
After switching to infliximab, a substantial proportion of patients with psoriasis and IR to etanercept experienced rapid and durable improvement.
Le texte complet de cet article est disponible en PDF.Key words : anti–tumor necrosis factor, etanercept, infliximab, nonresponder, psoriasis, sequential therapy, switch
Abbreviations used : BSA, CI, DLQI, HRQoL, IR, PASI, PASI 50, PASI 75, PASI 90, PASI 100, PGA, PGA 0/1, TNF, VAS
Plan
| Supported by Janssen Biotech Inc. |
|
| Disclosure: Dr Gottlieb has current consulting/advisory board agreements with Amgen Inc, Astellas, Centocor Inc, Celgene, Bristol Myers Squibb Co, Beiersdorf Inc, Abbott Labs, TEVA, Acetelion, UCB, Novo Nordisk, Immune Control, Dermipsor, Incyte, PureTech, Magen Biosciences, Cytokine Pharmasciences Inc, Alnylam, Ono, Pfizer, Schering, Canfite, BIND Biosciences Inc, and Merck, and has received research/educational grants (paid to Tufts Medical Center) from Centocor, Amgen, Immune Control, Abbott, Novo Nordisk, UCB, Novartis, Pfizer, and Celgene. Dr Kalb has received honoraria as consultant and speaker for Abbott, Amgen, Centocor, and Stiefel/GSK; as investigator for Abbott, Amgen, Centocor, and Astellas; and as consultant for Leo Pharma. Dr Blauvelt has received honoraria as a consultant for Amgen, Abbott, Centocor, Novartis, Lilly, Pfizer, Celgene, and Anacor. Dr Heffernan has been an investigator for Abbott, Amgen, Celgene, Centocor, Eli Lilly, Galderma, Glaxo Smith Kline, Incyte, Pfizer, Schering-Plough, Sirtris, Stiefel, Novartis, Novo Nordisk, Vascular Biogenics, and Wyeth, and he is on the speaker’s bureau for Abbott, Amgen, and Centocor. Dr Sofen has received honoraria and served as an investigator and speaker for Centocor. Dr Ferris has received honoraria and other financial benefits as an investigator and speaker for Abbott and Centocor and as an investigator from Amgen. Dr Kerdel has received grants and honoraria as an advisory board member, investigator, and speaker for Amgen, Abbott, and Centocor, and as a speaker for Pfizer. Dr Chevrier and Mr Calabro are employees of Janssen Biotech Inc. Dr Wang is an employee of Johnson & Johnson Pharmaceutical Research & Development. Dr Kerkmann is a former employee of Janssen Biologics BV. |
Vol 67 - N° 4
P. 642-650 - octobre 2012 Retour au numéro
Article précédent
- Open-label, pilot study examining sequential therapy with oral tacrolimus and topical tacrolimus for severe atopic dermatitis
- Terrence Colin Keaney, Tina Bhutani, Priya Sivanesan, Grace D. Bandow, Sari Beth Weinstein, Lawrence C.C. Cheung, Farah Malick, John Koo
- Risks of developing psychiatric disorders in pediatric patients with psoriasis
- Alexa B. Kimball, Eric Q. Wu, Annie Guérin, Andrew P. Yu, Magda Tsaneva, Shiraz R. Gupta, Yanjun Bao, Parvez M. Mulani
Bienvenue sur EM-consulte, la référence des professionnels de santé.
L’accès au texte intégral de cet article nécessite un abonnement.
Déjà abonné à cette revue ?