Clinical Effectiveness and Safety of Apremilast Monotherapy in Moderate Chronic Plaque Psoriasis: A Prospective Observational Study
DOI:
https://doi.org/10.52206/jsmc.2026.16.3.1375Abstract
Background: Psoriasis is a chronic immune-mediated inflammatory disease affecting the skin, nails, joints, and multiple systemic pathways. Plaque psoriasis is the most common clinical subtype and is frequently associated with significant physical, psychological, and social burden. Apremilast, an oral phosphodiesterase-4 inhibitor, has emerged as an effective therapeutic option for psoriasis owing to its favorable safety profile and ease of administration. However, evidence regarding its effectiveness and tolerability in routine clinical practice in Pakistan remains limited.
Objective: To evaluate the clinical effectiveness and safety of apremilast monotherapy in patients with moderate chronic plaque psoriasis.
Methodology: This prospective observational study was conducted at the Department of Dermatology, Hayatabad Medical Complex, Peshawar, Pakistan, between June and December 2023. A total of 120 adult patients with moderate chronic plaque psoriasis (PASI score 5–12) were enrolled using consecutive sampling. Participants received apremilast according to the standard dose-escalation regimen followed by a maintenance dose of 30 mg twice daily for 24 weeks. Clinical effectiveness was assessed using the Psoriasis Area and Severity Index (PASI), with treatment success defined as achievement of a 75% reduction from baseline PASI score (PASI-75). Safety was evaluated through documentation of treatment-related adverse events. Follow-up assessments were conducted at weeks 4, 8, 12, 16, and 24.
Results: Of the 120 enrolled patients, 110 completed the 24-week follow-up and were included in the effectiveness analysis. The mean age was 36.62 ± 9.08 years, and the mean disease duration was 6.28 ± 3.38 months. At week 24, 69 patients (62.7%) achieved PASI-75, indicating a favorable clinical response to treatment. The most commonly reported adverse events were nausea (19.1%), diarrhea (16.4%), headache (13.6%), vomiting (7.3%), and weight loss (6.4%). No significant associations were observed between treatment response and age, gender, or disease duration.
Conclusion: Apremilast monotherapy demonstrated favorable clinical effectiveness and an acceptable safety profile in patients with moderate chronic plaque psoriasis. The majority of adverse effects were mild to moderate and self-limiting. These findings support the use of apremilast as a practical and effective treatment option in routine dermatological practice. Larger controlled studies with longer follow-up periods are warranted to further establish its long-term effectiveness and safety.
Keywords: Apremilast, Clinical Effectiveness, PASI Score, Plaque Psoriasis, Psoriasis, Safety.
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