Infliximab study reinforces favorable safety profile for psoriasis therapy

Key Points

Boston - New findings from research investigating the use of infliximab (Remicade, Centocor) in patients with psoriasis provide further evidence of the value of this potent TNF-alpha blocker as a therapeutic option.

Results from the Prospective Study Using Remicade in Psoriasis Patients with an Inadequate Response to Etanercept (PSUNRISE) showed that in a cohort of 215 patients with a Physicians Global Assessment (PGA) score ≥2 after at least four months of treatment with etanercept (Enbrel, Amgen/Wyeth), 65.4 percent of patients achieved a PGA score of 0 (clear) or 1 (minimal) at week 10 after switching to infliximab 5 mg/kg.

More than three-fourths of patients in the responder population benefited with at least two grades of improvement in their static PGA, and with few exceptions, residual disease in patients who failed to meet the primary efficacy endpoint was categorized as mild (PGA score 2).

No new safety issues emerged, despite the fact that the patients had previously been treated with another TNF-alpha blocker, says Alice B. Gottlieb, M.D., Ph.D.

"Some patients requiring treatment with a biologic agent for their psoriasis or psoriatic arthritis will fail to respond to an initial TNF-alpha blocker, and others may lose their response over time. Therefore, it is useful to have a repertoire of multiple options to choose from," says Dr. Gottlieb, dermatologist in chief and chairwoman, department of dermatology, Tufts Medical Center, and Harvey B. Ansell Professor of Dermatology, Tufts University School of Medicine, Boston.

"The fact that infliximab is a more potent TNF-alpha blocker and administered by intravenous infusion on a weight basis suggests that it may be helpful for managing patients who have failed or lost response after treatment with another medication within this class. In fact, the results of PSUNRISE indicate that a high proportion of such patients may benefit from transitioning to infliximab," she says.

Study parameters

The 215 patients had a mean age of 44 years, were predominantly Caucasian (90 percent) and male (64 percent). They had a mean weight of 93.5 kg, mean duration of psoriasis of almost 20 years, and a baseline (first infliximab infusion) mean PGA score of 2.8, with about 68 percent of patients having a PGA score ≥ to 3. Eleven patients (5.1 percent) were on methotrexate or cyclosporine.

"The mean PGA score at screening was 2.7, indicating a lack of flares during the interval after etanercept withdrawal," Dr. Gottlieb says.

Secondary efficacy analyses considering changes in BSA of involvement, PASI 75 responder rates and improvement in the Dermatology Life Quality Index (DLQI) substantiated the benefit of transitioning to infliximab. At week 10, 52 percent of patients achieved a 75 percent improvement from their baseline PASI, and there was a mean 10.7 percent reduction in BSA. Both of these parameters reflected further positive response at week 26, and more than 40 percent of patients at weeks 10 and 26 achieved a DLQI less than or equal to 1.

Adverse events

Almost 70 percent of patients experienced at least 1 adverse event, but most were related to respiratory tract complaints or skin infections. Eight patients (3.7 percent) had a serious adverse event, including one serious infection.

Fifteen patients (7 percent) had withdrawn by week 10, but only six (2.8 percent) did so because of lack of efficacy. Safety follow-up continued to week 30, at which time an additional five patients had withdrawn due to lack of efficacy.

Disclosures: Dr. Gottlieb is a consultant or adviser for Amgen, Centocor, Wyeth, Celgene, Bristol-Myers Squibb, Beiersdorf, Abbott Labs, Teva, Actelion, UCB, Novo Nordisk, Immune Control, Dermipsor, Incyte, PureTech, Magen BioSciences, Cytokine PharmaSciences, Alnylam, Ono, Can-Fite and Schering. She is currently working under research grants - all of which are paid to Tufts Medical Center - provided by Centocor, Amgen, Wyeth, Immune Control, Celgene, Incyte, Abbott, Pfizer and Novo Nordisk.