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Infliximab Might Improve Quality-of-Life in Patients With Severe Plaque Psoriasis: Presented at AAD

By Bruce Sylvester

WASHINGTON, DC -- February 10, 2004 -- Infliximab (Remicade®) appears to provide improvement in measures of quality of life in patients with severe plaque psoriasis, researchers reported here February 8^th at the American Academy of Dermatology 62^nd Annual Meeting.

"Phase 2 clinical trials [of infliximab] have shown dramatic efficacy results for 90% of subjects in [the treatment of] severe plaque psoriasis skin lesions," said lead investigator Steven Feldman, MD, PhD, Professor of Dermatology, Pathology and Public Health Sciences, Wake Forest University School of Medicine; and Director, Psoriasis & Skin Treatment Center, Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States.

"This is an evaluation of quality-of-life data from [such a] study," Dr Feldman added.

For their study, Dr. Feldman and colleagues used the Dermatology Life Quality Index (DLQI), a 10-question instrument that addresses quality of life, including how much the patients are bothered by the treatment. The researchers saw little mean change in DLQI scores among placebo subjects, but both infliximab groups achieved a "dramatic" reduction in DLQI scores, he said.

"We saw scores dropping across the board," Dr. Feldman continued, "from ones that showed significant problems in several areas of life to limited problems in a few areas of life. We see that with infliximab treatment, every area of life measured showed significant mean improvement."

"The most striking finding of this study is the percentage of subjects who achieved a DLQI score of 0," he continued. "This means that, using our best means of detecting impact of psoriasis on their quality of life, psoriasis no longer [has an] impact [on] their quality of life at all."

Using the DLQI, the investigators analysed data on 249 subjects with severe plaque psoriasis in a double blind, randomised study. Patients were randomised to treatment with infliximab 3 or 5 mg/kg, or placebo. The patients were treated by infusion at weeks 0, 2 and 6. They completed the DLQI at baseline and at week 10.

Active treatment resulted in substantial improvement in DLQI scores, with a median percent change of 84% for 3 mg/kg, 91% for 5 mg/kg, and 0% for placebo (P < .001).

"The median change from baseline in DLQI at week 10 was -8.0 and -10.0 for the 3- and 5-mg/kg infliximab groups, respectively, compared with 0.0 in the placebo group," noted the researchers. "Thirty-three percent and 40% of patients [respectively] had a DLQI score of 0 at week 10, compared with 0% in the placebo group [P < .001]," according to the researchers.

"There may be some impact not detectable by this measure," noted Dr. Feldman, "but to the extent that we can detect it with this measure, [psoriasis] no longer has any impact -- not even a little bit of impact -- on their quality of life. In the 3-mg/kg group, about one-third of patients achieved that level of improvement. Forty percent achieved that level with the higher dose of 5 mg/kg. This is phenomenal. No one has ever talked about percentage of people who are no longer bothered in any way by their psoriasis."

Speaking specifically of treatment tolerability, Dr. Feldman said, "This also speaks to how well patients tolerate coming in for an infusion. If the score is 0, that means that they did not have any impact of treatment on their quality of life. And we all know that one of the most bothersome things about psoriasis is the treatments: They're messy [and] time-consuming. Here we see that 40% of the patients who [received] 5 mg/kg have 0 scores. So there is no impact of the treatment or anything else on their quality of life. Infliximab treatment causes tremendous improvement in lesions; but not only that, it is a well-tolerated therapy with, at least in this group and in short-term measures, dramatic quality-of-life improvements."

Infliximab is a chimeric, anti-tumour-necrosis factor (TNF)-alpha monoclonal antibody. In combination with methotrexate, infliximab is approved in the United States for reducing signs and symptoms, inhibiting the progression of structural damage and improving physical function in patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to methotrexate. It is also approved for reducing signs and symptoms and inducing and maintaining clinical remission in patients with moderately to severely active Crohn's disease.

This study was supported by Centocor, Inc.


[Study title: The Quality of Life of Patients with Severe Psoriasis Treated with Infliximab. Abstract 7]

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