Safety and Efficacy of Lenabasum, a Cannabinoid Receptor Type 2 Agonist, in Patients with Dermatomyositis with Refractory Skin Disease: A Randomized Clinical Trial

Werth, Victoria P.; Hejazi, Emily Z.; Peña, S.M.; Haber, Jessica S.; Zeidi, Majid; Reddy, Nithin; Okawa, Joyce; Feng, Rui; Bashir, Muhammad M.; Gebre, Kirubel; Jadoo, Arvin S; Concha, Josef Symon S.; Dgetluck, Nancy; Constantine, S.; White, Barbara

doi:10.1016/j.jid.2022.03.029

Cited by 30 publications

(21 citation statements)

References 59 publications

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“…Lenabasum, a selective cannabinoid 2 receptor agonist, was evaluated with a Phase 2 double-blinded RCT composed of 22 patients. 69 On day 113 of the trial, participants in the treatment group experienced a statistically significant decrease of 6.5 in their adjusted least square mean CDASI (p = 0.038). Similarly, there were statistically significant differences in secondary outcomes in biomarker changes, such as in IFN-beta and IFN-gamma (p < 0.05).…”

Section: Resultsmentioning

confidence: 95%

“… CDASI score improvement of −9.3 for 0.6 mg/kg, −8.8 for 1.8 mg/kg, and −7.3 for placebo. However, there was no significant difference in CDASI improvement between placebo and treatment groups (p = 0.238) Cannabinoid receptor agonists Werth (2022) 69 Phase 2 double blinded RCT Lenabasum 20mg daily for 28 days, then 20 mg BID for 56 days, or a placebo (Lenabasum is a cannabinoid receptor type 2 agonist) 22 subjects of ≥ 18 years of age with DM and CDASI activity ≥ 14 At day 113, the lenabasum treatment group, compared to the placebo group, had a lower CDASI adjusted least squares mean of 6.5 [SE = 3.1], p = 0.038. Abbreviations : DM, dermatomyositis; CDASI, cutaneous Dermatomyositis Disease Area and Severity Index; BID, twice daily; QAM, daily every morning; QPM, daily every evening; DAS, skin disease activity score; ILD, idiopathic lung disease; VAS, visual analog score; TLR, toll-like receptor; RCT, randomized controlled trial; SE, standard error.…”

Section: Resultsmentioning

confidence: 98%

“…Similarly, there were statistically significant differences in secondary outcomes in biomarker changes, such as in IFN-beta and IFN-gamma (p < 0.05). 69 …”

Section: Resultsmentioning

confidence: 99%

“… 67 , 68 The cannabinoid agonist, lenabasum, was found to significantly decrease patient mean CDASI. 69 …”

Section: Discussionmentioning

confidence: 99%

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Advancements in the Treatment of Cutaneous Lupus Erythematosus and Dermatomyositis: A Review of the Literature

Elhage¹,

Zhao²,

Nakamura³

2022

CCID

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Background Cutaneous lupus erythematosus (CLE) and dermatomyositis (DM) are autoimmune diseases that present with a wide variety of cutaneous manifestations. In both cases, first-line therapy includes topical corticosteroids. Patients may present with more widespread disease requiring systemic treatments, including corticosteroids, traditional immunosuppressants, or antimalarials. Due to their complex nature, both CLE and DM remain difficult to treat and continue to cause significant distress to patients. Objective To summarize the most recent literature on the safety and efficacy of novel treatment modalities for CLE and DM. Methods A literature search was conducted on PubMed using search terms “(dermatomyositis) AND (treatment)” and “(cutaneous lupus) AND (treatment)”. Additional search terms included specific names of biologic agents, phosphodiesterase inhibitors (apremilast), and JAK inhibitors. Results JAK inhibitors, PDE-4 inhibitors, and biologics have shown promise in reducing cutaneous symptoms of both CLE and DM, including reduction in SLE Disease Activity Index 2000 (SLEDAI-2K), Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI), British Isles Lupus Assessment Group (BILAG), Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI), and Disease Activity Score (DAS). Conclusion While there have been recent advancements in the treatment for CLE and DM, further research and clinical trials are required to better elucidate which therapy is best for individual patients.

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Section: Resultsmentioning

confidence: 95%

Section: Resultsmentioning

confidence: 98%

See 2 more Smart Citations

Advancements in the Treatment of Cutaneous Lupus Erythematosus and Dermatomyositis: A Review of the Literature

Elhage¹,

Zhao²,

Nakamura³

2022

CCID

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“…Lenabasum (JBT-101, anabasum), a selective cannabinoid receptor type 2 agonist, downregulated the expression of IL-31 from CpG stimulated peripheral blood mononuclear cells in an in vitro study, suggesting a possible role in treatment of DM-related pruritus [ 11 ]. Recently, a phase 2 study showed lenabasum improved skin symptoms with a reduction in the scores of CDASI [ 20 ]. Though the degree of pruritus was not evaluated in that trial, treatment with lenabasum might be efficacious for DM-related pruritus.…”

Section: Dermatomyositis (Dm)mentioning

confidence: 99%

Autoimmune Connective Tissue Diseases-Related Pruritus: Proper Diagnosis and Possible Mechanisms

Wong

Yen

2022

Diagnostics

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Pruritus is a well-known bothersome symptom among skin disorders, especially inflammatory skin disorders. Lately, a high prevalence of pruritus in patients with autoimmune connective tissue diseases (ACTDs) has been revealed. Patients with ACTDs may suffer from varying degrees of pruritus, which affect their quality of life. However, it is rarely recognized both by patients and physicians. Meanwhile, pruritus is not only a symptom but is also related to the disease severity of some ACTDs. The pathophysiology of ACTD related pruritus is ambiguous. This review summarizes the features and possible mechanisms of ACTD-related pruritus, which might lead to proper diagnosis and treatment.

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Understanding the Role of Type I Interferons in Cutaneous Lupus and Dermatomyositis: Toward Better Therapeutics

Hile,

Werth

2024

Arthritis & Rheumatology

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A 29‐year‐old female presented to a rheumatology‐dermatology clinic with a pruritic rash that began 6 months prior, after a viral illness. She had previously been diagnosed with eczema and treated with antihistamines and topical steroids without improvement. She also noted fatigue, hair loss, and severe scalp pruritus. Physical examination was notable for violaceous periorbital edema, scaly erythematous papules on the metacarpophalangeal joints of bilateral hands, dilated capillaries of the proximal nail folds, scaly plaques on bilateral elbows, and excoriated erythematous plaques on upper chest, back and hips. The patient reported no muscle weakness, and strength testing and creatinine phosphokinase were normal. Magnetic resonance imaging of the thigh showed no evidence of inflammation or edema. Antibody testing was negative. A diagnosis of clinically amyopathic dermatomyositis was made. Computed tomography scans of the chest, abdomen and pelvis, colonoscopy, and mammogram showed no evidence of cancer. The patient was initiated on methotrexate. Her cutaneous manifestations persisted with debilitating intractable pruritus, and thus, she was transitioned to mycophenolate mofetil, again with minimal improvement. Intravenous immunoglobulin was not approved by insurance given the lack of muscle involvement in her disease. This patient's case highlights a common clinical scenario in rheumatology and dermatology and raises several important issues related to the immunologic underpinnings of cutaneous lupus erythematosus (CLE) and dermatomyositis (DM): What is the role of type I interferon (IFN) in triggering skin disease in CLE and DM? What is the role of IFN in the pathogenesis of skin inflammation in CLE and DM? Can we apply what we know about IFN‐targeted therapeutics in CLE and DM to develop better treatments for skin disease?

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Safety and Efficacy of Lenabasum, a Cannabinoid Receptor Type 2 Agonist, in Patients with Dermatomyositis with Refractory Skin Disease: A Randomized Clinical Trial

Cited by 30 publications

References 59 publications

Advancements in the Treatment of Cutaneous Lupus Erythematosus and Dermatomyositis: A Review of the Literature

Advancements in the Treatment of Cutaneous Lupus Erythematosus and Dermatomyositis: A Review of the Literature

Autoimmune Connective Tissue Diseases-Related Pruritus: Proper Diagnosis and Possible Mechanisms

Understanding the Role of Type I Interferons in Cutaneous Lupus and Dermatomyositis: Toward Better Therapeutics

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