Long‐term 52‐week trends in apremilast safety outcomes for treatment of psoriasis in clinical practice: a multicentre, retrospective case series

Ighani, Arvin; Georgakopoulos, Jorge R.; Shear, Neil H.; Walsh, Scott; Yeung, Jensen

doi:10.1111/bjd.17099

Cited by 3 publications

(2 citation statements)

References 3 publications

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“…Diarrhea as an adverse event was expected from previous clinical trials of apremilast although our incidence was higher than previously reported 17,18 . One patient who experienced mild headache, reported as the most common reason for apremilast withdrawal, 19 continued the study.…”

Section: Discussionmentioning

confidence: 47%

“…Diarrhea as an adverse event was expected from previous clinical trials of apremilast although our incidence was higher than previously reported. 17,18 One patient who experienced mild headache, reported as the most common reason for apremilast withdrawal, 19 continued the study. There were no serious infections in this study although we observed inflammatory epidermal cyst flare up in one patient with a previous history.…”

Section: Ta B L E 1 Baseline Characteristics Of the Participantsmentioning

confidence: 99%

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Evaluation of apremilast, an oral phosphodiesterase 4 inhibitor, for refractory cutaneous dermatomyositis: A phase 1b clinical trial

Konishi

Tanaka

Inoue

et al. 2021

The Journal of Dermatology

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Dermatomyositis, an idiopathic inflammatory myopathy, is characterized by cutaneous itchy manifestations, which are frequently refractory and recurrent even after intensive immunosuppressive treatments. To evaluate the effectiveness and safety of apremilast, an oral phosphodiesterase 4 inhibitor, in treating skin‐dominant dermatomyositis in which myositis and interstitial lung disease are absent or in remission, we performed this prospective, single‐arm, interventional study. A total of five Japanese patients (one male and four females, median [range] age, 64 [37–71] years) with refractory dermatomyositis‐associated cutaneous manifestations were recruited and treated with a 12‐week course of oral apremilast. Among five enrolled patients, three experienced diarrhea with full‐dose apremilast (30 mg twice daily), two of whom withdrew from the study and recovered quickly afterwards. A total of three evaluable female patients (median [range] age, 65 [64–71] years) received apremilast treatment for 12 weeks. A 39.4% reduction from baseline Cutaneous Dermatomyositis Disease Area and Severity Index total activity score, but not the damage score, at week 12 was observed in all three patients. Visual analog scale of itching, and quality of life by Dermatology Life Quality Index were slightly improved in one and two apremilast‐treated patients, respectively. As apremilast was effective, with expected and recoverable digestive adverse events (diarrhea), in patients with refractory and recurrent dermatomyositis‐associated cutaneous manifestations in this first phase Ib study, it can be suggested as a possible treatment when aggressive immunosuppressive therapies with high‐dose systemic corticosteroid and/or immunosuppressive agents for other manifestations, myositis, and interstitial lung disease, are not required.

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Section: Discussionmentioning

confidence: 47%

Section: Ta B L E 1 Baseline Characteristics Of the Participantsmentioning

confidence: 99%

Evaluation of apremilast, an oral phosphodiesterase 4 inhibitor, for refractory cutaneous dermatomyositis: A phase 1b clinical trial

Konishi

Tanaka

Inoue

et al. 2021

The Journal of Dermatology

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Imperatorin Alleviates Psoriasiform Dermatitis by Blocking Neutrophil Respiratory Burst, Adhesion, and Chemotaxis Through Selective Phosphodiesterase 4 Inhibition

Tsai

Chen

Lin

et al. 2021

Antioxidants & Redox Signaling

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Review of suicide and depression in psoriasis and management of suicide warnings in patients treated with psoriasis drugs

Lebowitz

Lebwohl

2019

J of Skin

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Patients with psoriasis are thought to be at increased risk of depression, anxiety and suicidality predominantly as a result of the psychosocial impact of this disease. Studies have shown that the pro-inflammatory cytokines that are elevated in psoriasis and targeted by biologics have also been identified in patients with depression. It is therefore thought that anti-cytokine therapies may improve patients’ quality of life not only by reducing their disease burden but also by modulating the inflammatory pathways implicated in depression. While depression is mentioned in the package inserts of brodalumab and apremilast, only brodalumab has a black box warning requiring discussion of suicidality prior to prescribing the drug. In clinical trials, the majority of patients receiving brodalumab experience a reduction in symptoms of depression and anxiety. The package insert for brodalumab points out that no causal association has been established between brodalumab and suicide, and the FDA-mandated Risk Evaluation and Mitigation Strategies (REMS) program for brodalumab takes only minutes to complete. Brodalumab and apremilast may therefore be considered for patients in whom depression is caused by psoriasis, provided that patients and their providers have a mutual understanding of the risks and benefits of these therapies and the REMS program is followed.

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Long‐term 52‐week trends in apremilast safety outcomes for treatment of psoriasis in clinical practice: a multicentre, retrospective case series

Cited by 3 publications

References 3 publications

Evaluation of apremilast, an oral phosphodiesterase 4 inhibitor, for refractory cutaneous dermatomyositis: A phase 1b clinical trial

Evaluation of apremilast, an oral phosphodiesterase 4 inhibitor, for refractory cutaneous dermatomyositis: A phase 1b clinical trial

Imperatorin Alleviates Psoriasiform Dermatitis by Blocking Neutrophil Respiratory Burst, Adhesion, and Chemotaxis Through Selective Phosphodiesterase 4 Inhibition

Review of suicide and depression in psoriasis and management of suicide warnings in patients treated with psoriasis drugs

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