Research Demonstrates that Home Phototherapy is Non-Inferior to Office Phototherapy, with Excellent Effectiveness and Safety in Real World Settings
ALEXANDRIA, VA, UNITED STATES, March 9, 2024 -- Groundbreaking data presented today at the American Academy of Dermatology (AAD) Annual Meeting reveal new findings on the effectiveness of home phototherapy. Results from the Light Treatment Effectiveness (LITE) study, the largest study of its kind, demonstrate that home phototherapy is non-inferior to office phototherapy, with both home and office phototherapy demonstrating excellent effectiveness and safety in real world settings. The findings support the use of home phototherapy as a first line treatment option for psoriasis, including individuals with no prior phototherapy experience, and advocates for efforts to make phototherapy more available to people living with psoriasis.
Phototherapy involves exposing the skin to a specific wavelength of ultraviolet (UV) B light for the treatment of psoriasis and remains a preferred option for patients. However, major barriers affect the ability to access phototherapy in the dermatologist’s office, including limited geographic availability, the inconvenience of attending regular appointments for treatment, and high copays. Home phototherapy is available, but a relative lack of data on home phototherapy for psoriasis in the diverse U.S. population has resulted in health insurance companies being less likely to cover this treatment option, and health care providers may be uncertain about prescribing it.
Launched in 2019, the LITE study was designed to address this gap – the result of a collaboration between the National Psoriasis Foundation (NPF), the University of Pennsylvania Perelman School of Medicine, and the University of Utah. The LITE study is a large pragmatic randomized study embedded in routine clinical practice comparing the effectiveness, safety (tolerability), and duration of treatment response at 12 weeks of home versus office-based narrowband ultraviolet B phototherapy for the treatment of plaque or guttate psoriasis across all skin types. The study concluded in December 2023 after enrolling 783 patients with skin types I-VI at 42 dermatology practices across the U. S.
More patients randomized to home phototherapy achieved clear/almost clear skin (32.8% vs. 25.6%) and no to small effect on health-related quality of life (52.4% vs. 33.6%) compared to those randomized to phototherapy in the office after 12 weeks of treatment. The p value for non-inferiority was <0.0001 for both physician and patient reported outcomes, providing compelling evidence that home phototherapy works just as well as office treatment. Moreover, similar findings were observed in a priori defined subgroups of people with fair, medium complected, and darkly pigmented skin demonstrating that home phototherapy is an excellent alternative to office phototherapy for patients of all skin types. By planning for robust representation of patients of color, the LITE study yielded critical data to advancing health equity in the field of dermatology, and psoriasis in particular.
Results from the LITE study not only confirm the burden experienced by patients (travel time to the office and associated copay costs from each visit), but also demonstrated the importance of phototherapy in the modern era of psoriasis management. About 40% of patients had previously used pills or biologics for their psoriasis, and 12% of patients were currently taking oral or biologic medicines for psoriasis during the study. Furthermore, findings show that higher adherence to phototherapy leads to higher effectiveness. Approximately 60% of patients who completed on average 2 or more sessions per week over a 12-week period of home or office phototherapy achieved clear or almost clear skin, which is a high bar of effectiveness. The study authors emphasize that home phototherapy uses the same prescription-based narrow band 311 ultraviolet B bulbs as are used in dermatology offices. This form of light is distinct from commercial tanning beds, which use a different wavelength in the UVA spectrum that is not as effective for psoriasis and is associated with skin cancer and melanoma. Therefore, commercial tanning beds are generally not recommended for psoriasis treatment.
“These results are incredibly significant, as they are comparable to the effectiveness of many biologic and oral treatments for psoriasis.” said Joel M. Gelfand, M.D., M.S.C.E, principal investigator, and James J. Leyden Professor of Dermatology & Epidemiology at the Perelman School of Medicine at the University of Pennsylvania. “Health insurance companies should cover home phototherapy for treatment of psoriasis as standard of care, and dermatology providers should prescribe home phototherapy for management of psoriasis when medically appropriate and based on shared decision making with patients.”
“Findings from the LITE study are critical to patient health outcomes, especially for those in areas where office-based care is more challenging,” said Kristina Callis Duffin, M.D., co-principal investigator, and Professor and Chair of Dermatology at the Spencer Fox Eccles School of Medicine at the University of Utah. “These results should pave the way for new policies that improve access to home phototherapy such that any patient, the matter where they live in the U.S., should be able to access phototherapy for psoriasis when necessary.”
“Outcomes from this study could have a profound impact on health insurance coverage for individuals living with psoriasis,” said Kenneth L. Schaecher, MD, FACP, Interim Chief Medical Officer at University of Utah Health Plans, who served on the payer stakeholder committee for the LITE study. “I commend the LITE study for involving health insurance payers in this critical research, as we work together to transform the health of the psoriasis patients.”
The LITE study is funded by the Patient Centered Outcomes Research Institute (PCORI), an independent research institute authorized by Congress in 2010 that funds comparative clinical effectiveness research that engages patients and other stakeholders throughout the research process.
“We urge health insurance companies to make phototherapy more available to people living with psoriasis,” said Leah M. Howard, J.D., President and CEO of NPF. “Data from the LITE study strongly support the need for elimination of copays for phototherapy delivered in the office and the need for better coverage of home phototherapy machines to improve patient health outcomes for all populations across the United States.”
“Some individuals prefer phototherapy as a safe, effective alternative to systemic treatments,” said Alisha Bridges, who lives with psoriasis and served on the LITE patient stakeholder committee. “Results from the LITE study call for specific actions that will expand access to phototherapy and will ensure the psoriasis community live full and healthy lives. It’s critical to incorporate the perspectives of real people living with this disease into research so that outcomes are truly patient centered.”
Study results were presented today, Saturday, March 9, in the Late-Breaking Research Program at AAD Annual Meeting, held in San Diego on March 8-12, 2024. For more information on the LITE study, please visit: https://www.thelitestudy.com and https://classic.clinicaltrials.gov/ct2/show/NCT03726489.