Open-Label Phase 2 Pilot Study of Oral Tofacitinib in Adult Subjects With Discoid Lupus Erythematosus (DLE)

Alsukait, Sarah F; Learned, Christine; Rosmarin, David

doi:10.36849/jdd.7098

Cited by 3 publications

(1 citation statement)

References 5 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…An open‐label, single‐center phase II pilot study investigating tofacitinib for DLE was discontinued due to low recruitment. Of the five DLE patients who received 5 mg of oral tofacitinib BID for 24 weeks, two showed CLASI‐A score improvements of 75% by week 24 and two were less responsive, with a 30% improvement at weeks 16 and 24 40 . The results of the phase Ib/II trial in CLE are not yet published (NCT03288324).…”

Section: Ongoing Trialsmentioning

confidence: 99%

An update on clinical trials for cutaneous lupus erythematosus

Xie,

Lopes Almeida Gomes,

Stone

et al. 2024

The Journal of Dermatology

View full text Add to dashboard Cite

Cutaneous lupus erythematosus (CLE) comprises dermatologic manifestations that may occur independently or with systemic lupus erythematosus (SLE). Despite advancements in refining CLE classification, establishing precise subtype criteria remains challenging due to overlapping presentations and difficulty in distinguishing morphology. Current treatments encompass preventive measures, topical therapies, and systemic approaches. Hydroxychloroquine and glucocorticoids are the sole US Food and Drug Administration (FDA)‐approved medications for CLE, with numerous off‐label treatments available. However, these treatments are often not covered by insurance, imposing a significant financial burden on patients. The exclusion of most CLE patients, particularly those without concurrent SLE, from trials designed for SLE has resulted in a lack of targeted treatments for CLE. To develop effective CLE treatments, validated outcome measures for tracking patient responsiveness are essential. The Cutaneous Lupus Erythematosus Disease Area and Severity Index is widely utilized for its reliability, validity, and ability to differentiate between skin activity and damage. In contrast, the FDA mandates the use of the Investigator's Global Assessment, a five‐point Likert scale related to lesion characteristics, for skin‐related therapeutic trials. It requires the disease to resolve or almost completely resolve to demonstrate improvement, which can be difficult when there is residual erythema or incomplete clearance that is meaningfully improved from a patient perspective. Various classes of skin lupus medications target diverse pathways, allowing tailored treatment based on the patient's lupus inflammatory profile, resulting in improved outcomes. Promising targeted therapeutic drugs include anifrolumab (anti‐type 1 interferon), deucravacitinib (allosteric tyrosine kinase 2 inhibitor), litifilimab (plasmacytoid dendritic cell‐directed therapy), iberdomide (cereblon‐targeting ligand), and belimumab (B‐cell directed therapy). Despite the significant impact of CLE on quality of life, therapeutic options remain inadequate. While promising treatments for cutaneous lupus are emerging, it is crucial to underscore the urgency for skin‐focused treatment outcomes and the implementation of validated measures to assess therapeutic effectiveness in clinical trials.

show abstract

Section: Ongoing Trialsmentioning

confidence: 99%

An update on clinical trials for cutaneous lupus erythematosus

Xie,

Lopes Almeida Gomes,

Stone

et al. 2024

The Journal of Dermatology

View full text Add to dashboard Cite

show abstract

Emerging immunotherapeutic strategies for cutaneous lupus erythematosus: an overview of recent phase 2 and 3 clinical trials

Lim,

Kleitsch,

Werth

2023

Expert Opinion on Emerging Drugs

View full text Add to dashboard Cite

Impressive resolution of refractory hypertrophic discoid lupus erythematosus with anifrolumab

Ocon,

Avalos Sugastti,

Duffy

2024

BMJ Case Rep

View full text Add to dashboard Cite

Hypertrophic discoid lupus erythematosus is a rare variant of chronic cutaneous lupus erythematosus and is often challenging to treat. A male in his early 60s presented with diffuse erythematous, crusty, pruritic plaques on his upper and lower extremities, face, upper back, dorsal aspect of the hands and chest. He also described prolonged morning stiffness, swelling of his fingers and wrists, oral sores and Raynaud’s phenomenon. He was positive for antinuclear antibody and anti-SSA antibody and had low C3 and C4 proteins. The skin biopsy was consistent with hypertrophic discoid lupus erythematosus. He was diagnosed with systemic lupus erythematosus. Skin lesions were refractory to treatment with topical corticosteroids, topical acitretin, hydroxychloroquine, azathioprine or mycophenolate. Anifrolumab infusions were initiated with a near-complete resolution of cutaneous symptoms within 3 months.

show abstract

Open-Label Phase 2 Pilot Study of Oral Tofacitinib in Adult Subjects With Discoid Lupus Erythematosus (DLE)

Cited by 3 publications

References 5 publications

An update on clinical trials for cutaneous lupus erythematosus

An update on clinical trials for cutaneous lupus erythematosus

Emerging immunotherapeutic strategies for cutaneous lupus erythematosus: an overview of recent phase 2 and 3 clinical trials

Impressive resolution of refractory hypertrophic discoid lupus erythematosus with anifrolumab

Contact Info

Product

Resources

About