麻豆传媒

SAN DIEGO -- Home-based phototherapy for psoriasis achieved outcomes similar to office-based therapy, suggesting a potential for more convenient, less expensive treatment for some patients, according to a study reported here.

A third of patients treated at home had complete or near-complete clearance of psoriasis lesions at 12 weeks, across multiple skin types, as compared with a fourth of patients treated in office settings. Home treatment was associated with substantially better patient satisfaction and quality of life (QOL). Collectively, the data met prespecified criteria for noninferiority of home versus office treatment.

Home therapy was associated with more treatment sessions, higher cumulative dose (in joules), and more erythema persisting beyond 48 hours, but most patients reported little or no itchiness or discomfort, regardless of treatment setting, reported Joel M. Gelfand, MD, of the University of Pennsylvania in Philadelphia, at the American Academy of Dermatology (AAD) meeting.

"Home-based phototherapy is noninferior to office phototherapy across all skin types and for both primary outcomes," he said. "Both home and office phototherapy have excellent outcomes, both physician-reported and patient-reported, and both have excellent effectiveness and safety in a real-world setting."

"The data support use of home phototherapy as a first-line treatment option for psoriasis, including those with no prior phototherapy experience," Gelfand added. "We absolutely need to make home and office phototherapy more available to our patients."

In response to a question from the audience, Gelfand said investigators collected limited data on adverse events. The pragmatic study design eliminated as much research burden as possible for patients and providers. The equipment used in the study was standard for the time, and investigators were encouraged to follow AAD treatment guidelines with respect to dosing, treatment frequency, and other clinical parameters. Otherwise, clinicians were free to follow the standards of their office or practice.

In response to a question about differences in the anatomic location of lesions, Gelfand said randomization helped avoid imbalances in baseline characteristics.

Rationale for Trial

Phototherapy has a number of characteristics that patients and clinicians find attractive. The treatment is cost-effective (10-100 times less expensive than biologic therapy for psoriasis), has an excellent record for effectiveness and safety, and may have cardiovascular benefits (reduced interleukin-6, improved HDL cholesterol), said Gelfand.

A in the Netherlands showed that home- and office-based phototherapy for psoriasis achieved similar response rates with similar cumulative doses of ultraviolet B and no difference in short-time side effects. Patients found home-based therapy less burdensome, and their satisfaction with treatment and QOL were significantly better with treatment at home.

"We surveyed many patients and dermatologists across the U.S., and phototherapy remains a preferred form of therapy for patients, especially at home," said Gelfand. "However, inconvenience and copays remain a major barrier. As a result of a lack of U.S. data, many insurance companies do not want to cover phototherapy, making many providers uncertain about prescribing it."

To address the lack of data, investigators designed the , informed entirely by patients, providers, and other stakeholders. The trial tested the hypothesis that narrowband UVB phototherapy at home would be noninferior to office-based treatment of psoriasis with respect to outcomes that matter to patients, providers, and payers. The primary endpoints were physician global assessment (PGA) rating of 0/1 (clear/almost clear) and a Dermatology Life Quality Index (DLQI) score ≤5 (small to no effect on health-related QOL).

The study involved patients 12 or older with plaque or guttate psoriasis and suitable for phototherapy at home or in office. New and established patients were eligible but not patients who had received phototherapy in the 14 days prior to enrollment. The trial had a 15% noninferiority margin, derived from studies of biosimilars.

After randomization to home or office phototherapy, treatment continued for 12 weeks, at which time analysis of primary outcomes occurred. Patients were followed for an additional 12 weeks, whether on or off treatment. Data were obtained from office records or a cell phone app.

Key Findings

Data analysis included 783 patients who had a mean age of 48, and men accounted for 52% of the study population. Three-fourths of patients were white, followed by Black (9.3%) and Asian (7.2%). I/II and III/IV accounted for 45% each and V/VI for the remaining 10%. Mean body mass index was 29.6. Psoriasis duration averaged 15.8 years.

The study population had a mean baseline DLQI of 12.2, median PGA of 3, and mean body surface area of 12.5%. About 12% of patients were on biologic or other systemic therapy at enrollment, and 43% had prior exposure to phototherapy. Estimated travel time for phototherapy was 59 minutes, and the patient copay averaged $21.60.

The primary analysis showed that 32.8% of patients treated at home achieved a PGA rating of 0/1 as compared with 25.6% of patients randomized to office-based therapy (P<0.0001). Home-based therapy demonstrated noninferiority across all skin types, with the largest difference among patients with skin type V/VI (33.3% vs 14.6%, P=0.0001).

More than half (52.6%) of patients treated at home met the second primary outcome of DLQI ≤5 as compared with 33.6% of patients treated in an office (P<0.0001). Results were similar across all skin types.

Home phototherapy was associated with significantly more treatment sessions over the 12-week period (26.82 vs 17.95, P<0.0001). At-home treatment was associated with a higher cumulative phototherapy dose (31.43 vs 17.27 joules, P<0.0001).

Four patients in the office cohort had serious adverse events (breast cancer, osteosarcoma, chest pain, wound infection) versus five events in three patients with home therapy (substance abuse, neuropathy, malnutrition, COVID-related death, and hypertension).

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