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Shedding LITE on At-Home Phototherapy Treatment for Psoriasis

News
Article

Get a sneak peek ahead of AAD about the LITE study’s patient-centered design, routine care integration, and diverse participant inclusion, offering a cost-effective option in psoriasis treatment.

Joel Gelfand, MD, MSCE, FAAD, James J. Leyden Professor of dermatology and epidemiology at the University of Pennsylvania Perelman School of Medicine in Philadelphia, Pennsylvania, sat down in an interview with Dermatology Times and shared his perspective on the Light Treatment Effectiveness (LITE) study aimed to enhance accessibility to phototherapy for patients with plaque and guttate psoriasis. Gelfand expanded on the study’s background, significance of top line findings, and when you can learn more about the in-depth results at the 2024 American Academy of Dermatology Meeting next month.

Introduction

The LITE study, which shows that home phototherapy is noninferior to office-based phototherapy for the treatment of plaque and guttate psoriasis for all skin types and for both patient reported and physician reported outcomes, is a unique clinical trial in the field of dermatology for several reasons.1

First thing was that it was truly patient-centered and patient-driven. We had done a bunch of engagement work, talking to patients and advocates for patients. It turned out that, despite all the advances we have made in dermatology and psoriasis, patients were motivated to learn more about home phototherapy. They feel like that's a treatment they want better access to. That motivated us to do a study of home vs office phototherapy to determine if it could achieve similar outcomes as office phototherapy, but in a manner that is more patient centered.

LITE Study Background

Before now, there have not been large scale studies of phototherapy at home for psoriasis in the US, and as a result, clinicians are often uncertain about prescribing it. And insurers, especially private insurers, often don't want to pay for it. In contrast, Medicare covers home phototherapy for psoriasis. So, there is coverage for some payers, but not for a lot of private ones.

Home phototherapy employs the identical prescription-based narrow band 311 ultraviolet B bulbs found in dermatology offices. This type of light differs from those utilized in commercial tanning beds, which operate at a different wavelength within the UVA spectrum. The UVA spectrum used in tanning beds is less effective for treating psoriasis and is linked to skin cancer and melanoma. Consequently, it is generally advised against using commercial tanning beds for psoriasis treatment.

The study was also designed to be embedded in routine care. The entry criteria were very simple and reflect routine clinical practice: 1) Patients were 12 or older with plaque and/or guttate psoriasis; 2) Participating clinicians felt that the patient and their psoriasis was appropriate for phototherapy at home or in the office; and, 3) The patient was willing to be randomized to either home or office phototherapy. There was no requirement to stop other psoriasis treatments other than phototherapy itself, which needed to be discontinued 2 weeks prior to randomization for those currently using it.

There were 783 patients with skin types I-VI enrolled at 42 dermatology practices across the US. In the study about 12% of patients were on biologics and oral medications for psoriasis, we had a pregnant patient, people with active malignancy, and other major medical problems because this reflects what actually occurs in clinical practice and the decisions dermatologists and patients face every day.

The LITE study was funded by the Patient Centered Outcomes Research Institute (PCORI), which was authorized by Congress in 2010, and funds comparative clinical effectiveness research that engages numerous stakeholders from start to finish in a trial.

Data Collection

Data collection for the pragmatic, randomized trial was also very simple because we focused on data we routinely collect in patient care: a Physician Global Assessment (PGA) score and Body Surface Area (BSA) score—which are AAD MIPS measures for psoriasis and a Dermatology Life Quality Index (DLQI) score that the patient completed in an easy-to-use cell phone app. Similarly, we assessed burns from phototherapy from routinely collected data in the office or from the home phototherapy machines themselves which collect this data in order to deliver the proper dose to the patient.

Clinical Trial Diversity

The final, I think, most important unique aspect of the LITE study, is the diversity. We've been working on this for 20 years, with us providing the first US estimate of the true prevalence of psoriasis in African Americans.2 This study was specifically designed to prove that home phototherapy would work as well at home, or the office, whether you have very fair-skin, or very dark complected skin. You could imagine a scenario where, let's say you're fair skinned. Maybe home phototherapy is not titrated as carefully as in the office and you burn too much, which would lead to not wanting treatment. Or maybe if you're darker-skinned and the home machines have fewer bulbs than in the office which could result in longer treatment times. Maybe that would be a dissatisfier. We a priori designed the study based on a biological hypothesis to ensure that there would be a diverse enough population to definitively answer the study questions and help promote health equity.

Top Line Results of the LITE Study

Top line results of the study showed that treatment at home with phototherapy for plaque or guttate psoriasis is clearly noninferior to office-based treatments. Whether you're looking at physician reported outcomes, or patient reported outcomes, and no matter what skin type you are, it's not inferior across all those metrics, which is a really compelling finding. We feel given the nature, size, and the pragmatic and inclusive study design, that this is a type of data should be taken up rapidly into clinical practice.

Another unique thing about this study is we had stakeholders, like patients with psoriasis, providers who were experts in this area, and also payers involved in all aspects of the study. The patients, dermatology experts, and payers helped us design the study and pick endpoints meaningful to them. We were hopeful that having payers engaged would help us more quickly have these findings taken up into insurance decisions. Ultimately, the data should lead to better coverage for both home and office phototherapy.

We’ve certainly made a lot of progress in the management of psoriasis. Phototherapy remains highly relevant as the LITE study demonstrates. Our prior studies indicate that office phototherapy works as well as adalimumab objectively, but obtains better patient reported outcomes, and other work has demonstrated a lower risk of side effects, especially with infections, compared to secukinumab. We also have demonstrated that phototherapy may improve cardiovascular risk by lowering IL6 (a critical cytokine that causes atherosclerotic disease, while improving HDL (the “good” cholesterol). It’s biggest benefit, if you're a payer, is that it is about 10 to 100 times cheaper than biologics, however, there needs to be policy changes that reduce the direct and indirect costs to patients who decide to use phototherapy while preserving the ability of dermatologists to offer phototherapy in their office for those who need it.

Opportunities For Further Research in Other Conditions

As I reviewed at the 2024 Masterclasses in Dermatology conference, beyond that, a lot of new studies are emerging showing the role of phototherapy augmenting response to our most novel outstanding therapies. For example, a study showed that people going on dupilumab (Dupixent) for eczema who also used phototherapy get better faster.3 There are also studies about using phototherapy to augment response for topical JAK inhibitors for vitiligo.4 We're making a lot of progress in medicine, but it's not complete. There are plenty of patients out there who are doing okay on biologic therapy, or new small molecules, and many people who are not. Adding phototherapy to the mix us can really help us maintain response, help people, and get to the ultimate objective we are trying to achieve for them.5-8

Opportunity to Learn More at AAD

I will be presenting the detailed information and data during a late breaking session at the 2024 American Academy of Dermatology Meeting in San Diego, California. That session will take place on Saturday, March 9 at 9:50 am PST in Room 20BCD at the San Diego Convention Center.

References

  1. The Light Treatment Effectiveness (LITE) Study Demonstrates that Home Phototherapy may be Considered a First Line Treatment Option for Plaque or Guttate Psoriasis. News Release. National Psoriasis Foundation. February 22, 2024. Accessed February 22, 2024.
  2. Gelfand JM, Stern RS, Nijsten T, Feldman SR, Thomas J, Kist J, Rolstad T, Margolis DJ. The prevalence of psoriasis in African Americans: results from a population-based study. J Am Acad Dermatol. 2005 Jan;52(1):23-6. doi: 10.1016/j.jaad.2004.07.045. PMID: 15627076.
  3. Rossi M, Rovati C, Arisi M, et al. A short cycle of narrow-band UVB phototherapy in the early phase of dupilumab therapy can provide a quicker improvement of severe atopic dermatitis. Dermatology. 2021;237(3):407-415. doi:10.1159/000512456
  4. Phan K, Phan S, Shumack S, Gupta M. Repigmentation in vitiligo using janus kinase (JAK) inhibitors with phototherapy: systematic review and Meta-analysis. J Dermatolog Treat. 2022;33(1):173-177. doi:10.1080/09546634.2020.1735615
  5. McCoy T, Natarelli N, Pan A, Shakhbazova A, Sivamani RK, Chambers CJ. Systematic review and estimated cost-efficacy of biologics compared with narrowband ultraviolet B light for the treatment of moderate to severe psoriasis and atopic dermatitis. Int J Dermatol. 2023 Apr 17
  6. Mehta NN, Shin DB, Joshi AA, Dey AK, Armstrong AW, Duffin KC, Fuxench ZC, Harrington CL, Hubbard RA, Kalb RE, Menter A, Rader DJ, Reilly MP, Simpson EL, Takeshita J, Torigian DA, Werner TJ, Troxel AB, Tyring SK, Vanderbeek SB, Van Voorhees AS, Playford MP, Ahlman MA, Alavi A, Gelfand JM. Effect of 2 Psoriasis Treatments on Vascular Inflammation and Novel Inflammatory Cardiovascular Biomarkers: A Randomized Placebo-Controlled Trial. Circ Cardiovasc Imaging. 2018 Jun;11(6):e007394.
  7. Iversen L, Conrad C, Eidsmo L, Costanzo A, Narbutt J, Pinter A, Kingo K, Rivera Diaz R, Kolbinger F, Nanna M, Frueh JA, Jagiello P. Secukinumab demonstrates superiority over narrow-band ultraviolet B phototherapy in new-onset moderate to severe plaque psoriasis patients: Week 52 results from the STEPIn study. J Eur Acad Dermatol Venereol. 2023 May;37(5):1004-1016.
  8. Noe MH, Wan MT, Shin DB, Armstrong AW, Duffin KC, Chiesa Fuxench ZC, Kalb RE, Menter A, Simpson EL, Takeshita J, Tyring SK, Van Voorhees AS, Mehta NN, Gelfand JM. Patient-reported outcomes of adalimumab, phototherapy, and placebo in the Vascular Inflammation in Psoriasis Trial: A randomized controlled study. J Am Acad Dermatol. 2019 Oct;81(4):923-930. doi: 10.1016/j.jaad.2019.05.080. Epub 2019 Jun 1. PMID: 31163241; PMCID: PMC6746579.
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