Etanercept plus narrow-band UVB

September 1, 2006

The combination regimen was associated with about a 50 percent improvement in symptoms of depression evaluated using the Beck Depression Inventory.

Etanercept (Enbrel, Immunex) plus narrow-band UVB appears to be an efficacious and generally well-tolerated combination regimen for treating moderate-to-severe plaque psoriasis, according to the results of an open-label, prospective, multicenter study presented at Academy '06.

The 12-week trial enrolled 86 patients at 14 investigational sites in Canada and the United States. Etanercept was administered subcutaneously, 50 mg twice a week, and the phototherapy sessions were performed three times a week. Eighty-three (97 percent) patients completed the trial.

STUDY SPECIFICS

The proportion of patients achieving 75 percent or greater improvement in PASI score (PASI-75) after 12 weeks was analyzed as the primary efficacy endpoint, and that outcome was achieved by 85 percent of subjects. Notably, 70 percent of patients were PASI-75 responders by week eight, and the mean time to PASI-75 response was 59 days.

Multiple other secondary and exploratory endpoints were used to measure efficacy and the impact of treatment on function, symptoms and emotional health, and the results of those assessments were consistent in showing highly favorable effects. In addition, the combination regimen was well-tolerated. A single patient withdrew because of a photosensitivity reaction, but there was no evidence that the dual regimen increased the risk of serious or immune-related adverse events.

"Dermatologists often combine therapeutic modalities to enhance outcomes when treating a variety of cutaneous disorders, and psoriasis is no exception. However, there has been concern about the safety of combining a biologic with phototherapy with regard to the potential for increased immune system depression," says Leon H. Kircik, M.D., clinical associate professor of dermatology, Indiana University School of Medicine, Indianapolis, and also medical director, DermResearch PLLC and Physicians Skin Care, PLLC, Louisville, Ky.

"While there have been anecdotal reports from physicians using biologics with phototherapy, to our knowledge, the combination of etanercept and narrow-band UVB has not been formally investigated in a large number of patients. The experience in this study shows that adding phototherapy augments the response to etanercept, with significant improvement occurring in more patients and faster without any compromise of safety."

A LOOK AT STUDY SUBJECTS

Study eligibility criteria required patients to have:

No prior phototherapy or treatment with a tumor necrosis factor antagonist was allowed. The enrolled patients had more than one-fourth of their BSA affected by psoriasis and about half had been treated with a variety of systemic therapies.

Analysis of other PASI response measures showed 58 percent of patients achieved 90 percent or greater reduction in PASI score, and about one-fourth were PASI-100 responders.

The study also investigated patient-rated efficacy outcomes, including the Dermatology Life Quality Index (DLQI) and a Global Assessment of Psoriasis. Those results reflected the high PASI response rates. By week 12, the DLQI total score improved by a mean of about 82 percent, although almost all of the benefit was achieved by week eight, and the magnitude of improvement was similar in all of the subscales of the DLQI. In addition, in the global assessment of psoriasis, patients rated their mean improvement from baseline as 80 percent.

Other assessments in the study showed the treatment had a positive effect on improving itching and fatigue, which was measured using the Functional Assessment of Chronic Illness Therapy - Fatigue. In addition, the combination regimen was associated with about a 50 percent improvement in symptoms of depression evaluated using the Beck Depression Inventory.

"This study incorporated a comprehensive assessment of the patient's perspective of treatment, which strengthens its design and the value of its findings. After all, patient satisfaction with treatment is the bottom line," Dr. Kircik says.

Disclosure: Dr. Kircik is an investigator, consultant and/or speaker for Amgen, Biogen, Genentech and Centocor.