Original article
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

A subset of data contained in this article was presented previously at the following meetings: European Society of Dermatological Research Congress, Budapest, Hungary (September 9-12, 2009); 68th Annual Meeting of the American Academy of Dermatology, Miami, Florida (February 26-March 2, 2010); Third International Congress on Psoriasis, Paris, France (July 1-4, 2010); European Academy of Dermatology and Venereology Fall Symposium, Gothenburg, Sweden (October 6-10, 2010); and Fall Clinical Dermatology Conference, Las Vegas, Nevada (October 8-11, 2010).
https://doi.org/10.1016/j.jaad.2011.10.020Get rights and content

Background

In patients with psoriasis and inadequate response (IR) to tumor necrosis factor-α antagonist treatment, the incremental benefit of switching to another tumor necrosis factor-α 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.

Section snippets

Patients and study design

This multicenter, open-label study (PSUNRISE) was designed to evaluate clinical changes after a treatment switch to infliximab because of IR to etanercept in patients with plaque psoriasis. Patients received intravenous infusions of infliximab 5 mg/kg (Remicade, Janssen Biotech Inc, Horsham, PA, a subsidiary of Johnson & Johnson) administered over 2 hours at weeks 0, 2, 6, 14, and 22. Institutional review board or ethics committee approval and patient informed consent were obtained before

Results

In all, 215 patients were enrolled at 49 study centers in North America. A total of 36 patients (16.7%) withdrew consent or terminated study participation (n = 21 before week 10), one of whom returned at week 30. Thus, 179 patients completed the study and 180 patients completed the week-30 follow-up visit. The most common reasons for study termination were adverse events (n = 13) and lack of efficacy (n = 11); 4 patients discontinued because of worsening of psoriasis. The majority of patients

Discussion

The results of this 30-week, multicenter, open-label study indicate that, in many patients with active plaque psoriasis who exhibit an IR to etanercept, switching to infliximab results in a significant improvement in disease activity. Based on standard assessments of efficacy in psoriasis, the response was rapid, substantial, and durable through week 26. A large percentage of patients (65.4%) achieved PGA 0/1 and at least PASI 75 at week 10. Such responses are considered to be clinically

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    • Cited by (0)

    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.

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