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Myositis
Published in Jason Liebowitz, Philip Seo, David Hellmann, Michael Zeide, Clinical Innovation in Rheumatology, 2023
Apremilast is a phosphodiesterase-4 enzyme inhibitor that is FDA approved for other inflammatory diseases (psoriasis, psoriatic arthritis, Behçet’s disease). A few case reports suggested efficacy in refractory cutaneous DM.96 Given this data, an open-label, single-arm clinical trial is being conducted to evaluate its safety and efficacy in refractory cutaneous DM, of which the results are expected to be published soon.
Newer Agents in Systemic Treatment
Published in Vineet Relhan, Vijay Kumar Garg, Sneha Ghunawat, Khushbu Mahajan, Comprehensive Textbook on Vitiligo, 2020
Rachita Dhurat, Shilpi Agarwal
Apremilast is an oral small-molecule phosphodiesterase-4 (PDE4) inhibitor that regulates inflammatory mediators. It elevates levels of cyclic adenosine monophosphate, which is a modulator of inflammatory responses [23,24], thus decreasing proinflammatory mediators, like tumor necrosis factor (TNF)-α, interleukin (IL)-23, and interferon gamma, and increased production of IL-10, an anti-inflammatory cytokine [25]. Apremilast is shown to modulate the inflammatory cycle in many studies. Other mechanisms for decreased proinflammatory cytokine production include toll-like receptor 4 agonism in peripheral blood mononuclear cells, T-cell receptor agonism, cytokine and immunoglobulin receptor agonism on natural killer cells, and ultraviolet light exposure of keratinocytes. All these mechanisms have proven their role in psoriasis and psoriatic arthritis [26]. In March 2014, the Food and Drug Administration (FDA) approved apremilast for adults with active psoriatic arthritis [27].
Current Recommendations for the Treatment of Psoriasis
Published in Siba P. Raychaudhuri, Smriti K. Raychaudhuri, Debasis Bagchi, Psoriasis and Psoriatic Arthritis, 2017
Apremilast is a relatively new oral small-molecule PDE4 inhibitor that was approved by the FDA in 2014 for the treatment of psoriasis. Large randomized trials demonstrate achievement of PASI 75 in roughly 30% of patients. Its efficacy appears to be dose dependent and is inferior to that of cyclosporine, ustekinumab, and anti-TNF biologic agents.68,69 Its main advantage is its relative safety, precluding the need for routine lab monitoring. The most common side effect is diarrhea when treatment is initiated; tolerability may be improved by uptitrating the dose by 10 mg/day over 1 week. Other adverse effects include upper respiratory infection, headache, weight loss, and depression. The associated weight loss may be one reason for this drug’s popularity.
Comparison of psoriasis guidelines for use of apremilast in the United States and Europe: a critical appraisal and comprehensive review
Published in Journal of Dermatological Treatment, 2022
Rima I. Ghamrawi, Neda Ghiam, Jashin J. Wu
The AAD and NPF released joint guidelines for the treatment of psoriasis with systemic non-biologic therapies in February 2020 (14). Apremilast is effective in the treatment of moderate-to-severe psoriasis with scalp and palmoplantar involvement. Additionally, apremilast may be used to treat psoriatic arthritis. A large randomized control trial of 504 patients evaluated American College of Rheumatology 20 (ACR20) scores and reported increased efficacy in treating joint disease in patients taking 20 mg twice a dady (BID) (30.4%) and 30 mg BID (38.1%) dosages compared to placebo (19.0%) at 16 weeks (14). Additionally, in patients with psoriatic arthritis, the NICE and Swiss S1 guidelines recommend apremilast, either alone or in combination with disease-modifying antirheumatic drugs (DMARDs). This recommendation is for the treatment of active disease in adults if they have three or more tender and swollen joints and their disease has been unresponsive to adequate treatment with two or more DMARDs. In contrast, the AAD-NPF (14) and Italian guidelines (22) report the indication for psoriatic arthritis, but do not specify a requirement for previous treatment with DMARDs (14,19,21,22,27).
Positioning of apremilast in treatment of Behçet’s disease
Published in Modern Rheumatology, 2020
Apremilast is one of the candidates that satisfy these unmet needs. Recent clinical studies have shown the efficacy and safety of apremilast against oral ulcers in BD patients [7–9]. A phase 2 clinical trial, which was conducted in Turkey and the USA, showed that apremilast was effective in reducing the number and pain of oral ulcers and overall disease activity while improving the quality of life in BD patients with mucocutaneous involvement [7]. Subsequently, a global, phase III, multicenter, randomized, double-blind, placebo-controlled study, RELIEF enrolled a total of 207 BD patients having active oral ulcers despite at least one previous medication from 10 countries including Japan [8]. This trial evaluated the efficacy, safety, and tolerability of apremilast. In the trial, the primary endpoint was the area under the curve (AUC) for the number of oral ulcers through 12 weeks (AUC0-12wk), which was significantly lower in the apremilast group than control. Reduction of the number and pain in the visual analogue scale (VAS) of oral ulcers were observed as early as 1st week and the efficacy continued during the administration. Although beneficial effects on the other BD related individual symptoms were not statistically proven, overall disease activity assessed by Behçet’s Syndrome Activity Score (BSAS) and Behçet’s Disease Current Activity Form (BDCAF) were significantly more improved in the apremilast group than in the control group. This was the case for Behçet’s Disease Quality of life (BDQoL) as well.
Real-world data on the efficacy and safety of apremilast in Japanese patients with plaque psoriasis
Published in Journal of Dermatological Treatment, 2019
Chika Ohata, Bungo Ohyama, Fumi Kuwahara, Eri Katayama, Takekuni Nakama
We retrieved data on all the patients with plaque psoriasis who were administered with at least one dose of apremilast and had at least one follow-up visit at the Kurume University Hospital between May 2017 and June 2018, with June 30 2018 as the data lock date. Apremilast was administered under prescription, starting with 10 mg/day and gradually increasing the dosage stepwise by 10 mg up to 30 mg twice/day, unless a decreased dosage was necessary. All the patients used topical corticosteroids, vitamin D analogs, and/or emollients throughout the study period. We collected and analyzed clinical data for sex, age at onset, age at baseline, body mass index (BMI), proportion with concurrent psoriatic arthritis, and Psoriasis Area and Severity Index (PASI) at baseline. In addition, we analyzed data regarding the patients’ previous treatments, apremilast treatment duration, and concurrent treatments other than topical corticosteroids, vitamin D analogs, and/or emollients. Drug efficacy was evaluated in terms of final PASI, best PASI, and duration until the best PASI was achieved. Data for AEs were also collected. The Kurume University School of Medicine Review Board approved this study.