Original article
Efficacy and safety of adalimumab in patients with plaque psoriasis who have shown an unsatisfactory response to etanercept

https://doi.org/10.1016/j.jaad.2009.08.040Get rights and content

Background

The safety and efficacy of adalimumab in patients who have shown an unsatisfactory response to etanercept are unknown.

Objective

We sought to evaluate the safety and efficacy of adalimumab in patients who failed to show a satisfactory response or lost their satisfactory response to etanercept.

Methods

This multicenter study enrolled patients who either failed to reach a physician global assessment (PGA) score of 0 or 1 after 12 weeks of etanercept (group A; 50 patients) or who lost their PGA score of 0 or 1 at any time after etanercept dose decrease from 50 mg twice a week to 50 mg every week (group B; 35 patients). Patients received adalimumab 40 mg every other week without loading dose for 12 weeks followed by 40 mg every week for an additional 12 weeks if they did not reach a PGA score of 0 or 1.

Results

After 12 weeks of adalimumab, 34.0% (n = 17; 95% confidence interval [CI] 20.4-47.6) and 31.4% (n = 11; 95% CI 15.2-47.6) of patients from groups A and B, respectively, reached a PGA score of 0 or 1. A total of 46.0% (n = 23; 95% CI 31.7-60.3) and 45.7% (n = 16; 95% CI 28.4-63.1) of patients from group A and B, respectively, achieved a PGA score of 0 or 1 after 24 weeks of adalimumab. Adalimumab was well tolerated and no serious adverse events were reported.

Limitations

This was an open-label uncontrolled study.

Conclusions

Adalimumab should be considered as an alternative in patients with psoriasis who have not shown an adequate response or who lost their response to etanercept after a dose decrease.

Section snippets

Patients

To be eligible, patients had to be between 18 and 80 years of age and have plaque psoriasis at screening that was severe enough for a systemic therapy. Patients with poorly controlled medical conditions such as uncontrolled diabetes; patients with symptoms of demyelinating diseases, a history of cancer, listeriosis, tuberculosis, persistent chronic infections, or immunodeficiency; or patients who had taken live attenuated vaccine within 28 days of baseline were excluded from the study.

All

Demographics and patient disposition

A total of 85 patients were included in this study (50 patients in group A and 35 patients in group B). The original plan was to include 50 patients in both groups. However, recruitment of patients who presented a PGA score of 0 or 1 after 12 weeks of etanercept followed by an increase in PGA score to 2 or higher upon etanercept dose reduction was more difficult than anticipated. As recruitment was not progressing, it was decided to stop enrollment during the spring of 2008. Demographics of

Discussion

Treatment of patients with moderate to severe psoriasis has changed dramatically since the approval of biological agents. In addition to topical therapy, phototherapy, and the oral systemic agents, there are, at the time of this writing, 5 biologics approved in various countries for the treatment of psoriasis with at least one more pending approval.7, 8 Choosing the best treatment for moderate to severe psoriasis becomes more complex both for patients and clinicians. Biologics targeting

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Supported by Innovaderm Research Inc and an investigator grant from Abbott Laboratories.

Disclosure: Dr Bissonnette has been a speaker, consultant, investigator, and/or advisory board member for Abbott, Amgen-Wyeth, Astellas-Pharma, Celgene, Centocor, EMD Serono, Galderma, Isotechnika, Leo Pharma, MedImmune, Ortho Biotech, Pfizer, and Schering-Plough Canada. He has received compensation in the form of grants and/or honoraria from these companies. Dr Bolduc has been a speaker, consultant, investigator, or advisory board member for Leo Pharma, Abbott, Amgen-Wyeth, Centocor, MedImmune, and Schering-Plough Canada. She has received compensation in the form of grants and/or honoraria from these companies. Dr Guenther has been a speaker, consultant, investigator, and advisory board member for Abbott, Amgen, Astellas-Pharma, Centocor, EMD Serono, Leo Pharma, Ortho Biotech, Novartis, Schering-Plough, and Wyeth. Dr Lynde has acted as a speaker and consultant for Astellas-Pharma, EMD Serono, Schering-Plough Canada, Abbott, Leo Pharma, and Amgen and receives compensation in the form of grants and honoraria. Dr Maari has been a speaker, consultant, investigator, and/or advisory board member for Abbott, Amgen-Wyeth, Astellas-Pharma, Centocor, Galderma, MedImmune, Ortho Biotech, and Schering-Plough Canada. She has received compensation in the form of grants and/or honoraria from these companies. Dr Poulin has been a speaker, consultant, investigator, and/or advisory board member for Abbott, Amgen-Wyeth, Astellas-Pharma, Bristol-Myers Squibb, Boehringer-Ingelheim, Centocor, EMD Serono, Galderma, Ortho Biotech, and Schering-Plough Canada. He has received compensation in the form of grants and/or honoraria from these companies.

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