A Retrospective Analysis of 72 Patients on Prior Efalizumab Subsequent to the Time of Voluntary Market Withdrawal in 2009
June 2014 | Volume 13 | Issue 6 | Original Article | 712 | Copyright © 2014
Elizabeth Farley Prater MD,a Antoinette Day BS,b Mahir Patel MD,c and Alan Menter MDc
aUniversity of Oklahoma College of Medicine, Department of Dermatology, Oklahoma City, OK
bTexas A&M Health Science Center College of Medicine, College Station, TX
cBaylor University Medical Center, Department of Dermatology, Dallas, TX
BACKGROUND: Efalizumab was voluntarily withdrawn from the market in April 2009 after four cases of Progressive Multifocal Leukoencephalopathy.
OBJECTIVE: To review the baseline characteristics and psoriasis phenotypes of patients with prior excelled response to efalizumab, and to determine the response of these patients to prior as well as subsequent therapies. By defining this subgroup of patients, particularly relating to palmoplantar psoriasis, future therapeutic considerations could be improved.
DESIGN: A retrospective review of 72 patients who were on efalizumab at the time of market withdrawal was conducted. Data was obtained through chart review of patients at a specialty psoriasis clinic in Dallas, TX.
MAIN OUTCOMES AND MEASURES: Patient characteristics, details of efalizumab use, and efficacy of efalizumab compared with other psoriasis treatment modalities.
RESULTS: Of the 72 patients, 24 (33%) were found to have palmoplantar disease. As a group, these patients were older, more likely to be female, and less likely to have a family history of psoriasis. 48 patients (67%) were on one or more systemic and/or biologic medication prior to starting efalizumab. Their BSA improved from 5.45 to 0.8 as a group. Six patients were identified as having failed TNF alpha antagonist treatment prior to starting efalizumab. All responded well to the medication with an average BSA of 0.54. Five of these six patients had evidence of palmoplantar disease prior to starting efalizumab and five of these six patients were female. Eleven patients (15%) experienced neurologic side effects and 13 (18%) had infections while on efalizumab treatment.
LIMITATIONS: This was a retrospective review. Quality of life issues could not always be fully assessed from the data available.
CONCLUSIONS AND RELEVANCE: Efalizumab was effectively utilized in our clinical practice to treat patients with palmoplantar psoriasis, including six patients who had failed prior treatment with one or more TNF alpha antagonist agents.
J Drugs Dermatol. 2014;13(6):712-718.
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Psoriasis is a systemic inflammatory disease effecting roughly 2% of the population.1,2 The effects of psoriatic skin disease have been shown to cause significant quality of life impairment equivalent to diseases such as diabetes, cardiovascular disease and in severe cases even cancer.3 In addition to cutaneous involvement, psoriatic joint disease which effects up to 30% of patients can lead to devastating joint destruction. Although mild to moderate psoriasis is often treated successfully with topical therapy or phototherapy, severe psoriasis requires systemic therapy. Traditional systemic agents such as methotrexate, cyclosporine and acitretin are relatively effective but are limited by their systemic toxicities and organ specific side effects. The era of biologic medications has improved psoriatic disease control and the hope of better patient safety.4,5,6
As the second biologic medication to be approved for psoriasis in 2003, efalizumab showed promising results for a patient population that was in need of improved treatment options.7,8 In 2006, etanercept was the first anti tumor necrosis factor alpha drug specifically approved for psoriasis. With this new class of medication, improved psoriatic skin disease control was accomplished.9 Once adalimumab and infliximab gained approval for psoriasis, the use of efalizumab became somewhat of a “niche drug”. For reasons still to be fully elucidated, efalizumab appeared to be most effective in a small subset of patients with psoriasis who were relatively resistant to anti-TNFa drugs. Within this group, we believe that patients with recalcitrant palmoplantar psoriasis predominantly of the pustular phenotype, often responded well to efalizumab after failing many other traditional systemic and biologic medications. While there is a paucity of studies addressing palmoplantar psoriasis therapy, these patients often have a severely impacted quality of life.10-15 There are only occasional reports in the literature of patients with palmoplantar pustulosis who had failed multiple systemic therapies and subsequently cleared with efalizumab.16