A clinical trial enrolling patients with moderate-to-severe psoriasis was undertaken to determine the efficacy, safety and adherence to home narrowband UVB phototherapy plus low-dose acitretin. After 12 weeks, the subjects had an approximate 25 percent reduction from baseline PASI score. Safety, tolerability and patient acceptance were all favorable.
Winston-Salem, N.C. - Home narrowband UVB (NBUVB) phototherapy may be a therapeutic option for selected psoriasis patients when access to office-based treatment is limited or difficult, according to researchers from Wake Forest University Health Sciences, Winston-Salem, N.C.
DISCLOSURES: The study was supported by National Biological Corp. and Connetics. Dr. Yelverton reports no financial interest in the companies. Dr. Feldman has received research and speaking support from Connetics.
Christopher B. Yelverton, M.D., M.B.A., and colleagues in the department of dermatology reported preliminary results from a clinical trial they undertook to investigate the efficacy, safety and adherence to self-administered home phototherapy three times a week in patients with moderate-to-severe psoriasis. All patients were additionally treated with low-dose acitretin (Soriatane, Connetics), 10 mg/day to 25 mg/day.
None of the patients achieved the primary efficacy endpoint of a 75 percent improvement from baseline Psoriasis Area and Severity Index (PASI) score. But the mean PASI score was significantly improved from baseline by week eight and there were significant improvements in both the mean Physician's and Subject's Global Assessment (PGA) scores by week four.
The phototherapy was relatively safe, well-tolerated and generally met with good patient acceptance. Data on adherence was available for only five patients so far, and the analyses showed adherence was at least as good, if not better than reported in published studies of other psoriasis treatments. However, there was also appreciable variation in adherence among the patients and an overall tendency for adherence to acitretin and phototherapy to decrease over time.
"This study was designed to address the paucity of clinical trials evaluating home phototherapy and to see if its use would allow a dose reduction for concomitantly administered acitretin," Dr. Yelverton tells Dermatology Times.
"Although we were hopeful that the magnitude of responses achieved would be greater, the subjects were, overall, pleased with the therapy, and several were interested in purchasing a home phototherapy unit when the study was over. Now, we will be further analyzing the adherence data to determine correlations between adherence and outcomes and are planning additional studies of home NBUVB phototherapy without acitretin to gather more information about the role of this modality in psoriasis management."
Dr. Yelverton is a research fellow in the department of dermatology. Steven R. Feldman, M.D., Ph.D., professor of dermatology, pathology and public health science, Wake Forest University Health Sciences, was the senior author of the study.
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Patients were eligible for participation if their psoriasis involved more than 10 percent of the body surface area and they had a PGA rating of 3 or higher or a PASI score of 12 or higher.
At baseline, the enrolled patients had a mean PASI score of 18.56 and mean PGA score of 3.48. The mean subject's global assessment (SGA) score was 4.26.
The phototherapy unit used was a single panel that was 6 feet long and contained six bulbs (National Biological Corporation). Initial dosage was based on skin type, manufacturer recommendations and published protocols. Patients were instructed to increase the dose as tolerated. No patient experienced significant adverse events associated with the upward titration, although some reported mild erythema and tingling.
Patients were seen in the office every two weeks during the first month and then at monthly intervals for assessment of efficacy and safety. Mean PASI, PGA and SGA scores decreased progressively throughout follow-up and reached 13.98, 2.61 and 2.68, respectively, at week 12.
The NBUVB units were equipped with a data logger for recording usage. During the 12 weeks of the study, the five individuals with available data used the phototherapy unit for an average of 75 percent of the total possible sessions. However, one subject showed more than 90 percent adherence while another used the phototherapy unit less than 50 percent of the expected number of times.
The acitretin bottles were also equipped with an electronic monitor in the cap. The overall results for the analysis of medication adherence corresponded fairly well to the mean phototherapy adherence findings. However, adherence patterns to the two treatments differed in some individuals.
There were no serious adverse events related to acitretin treatment, although some patients needed a reduction of their medication dose because they developed elevated triglycerides.