Comparative Efficacy of Apremilast and Acitretin in Moderate-to-Severe Hidradenitis Suppurativa

Comparative Efficacy of Apremilast and Acitretin in Moderate-to-Severe Hidradenitis Suppurativa

This randomized controlled trial compares the efficacy of oral apremilast and oral acitretin in the treatment of moderate-to-severe hidradenitis suppurativa. Seventy eligible adults were randomly assigned to receive either apremilast (30 mg twice daily) or acitretin (25 mg twice daily) for 12 weeks. The primary outcome was improvement in disease severity measured using the International Hidradenitis Suppurativa Severity Score System (IHS4). The study aims to determine which treatment provides greater clinical improvement and may help guide treatment decisions for patients with moderate-to-severe hidradenitis suppurativa.

Hidradenitis suppurativa (HS) is a chronic inflammatory skin disease characterized by recurrent painful nodules, abscesses, sinus tracts, and scarring, resulting in considerable impairment in quality of life. Although several systemic therapies are available, evidence directly comparing oral non-biologic treatment options remains limited.

This investigator-initiated, single-center, randomized controlled trial was conducted at the Department of Dermatology, Medical Teaching Institution-Hayatabad Medical Complex, Peshawar, Pakistan. Seventy adults aged 18 to 40 years with clinically diagnosed moderate-to-severe hidradenitis suppurativa were enrolled and randomly allocated in a 1:1 ratio to receive either oral apremilast 30 mg twice daily or oral acitretin 25 mg twice daily for 12 weeks.

Disease severity was assessed using the International Hidradenitis Suppurativa Severity Score System (IHS4). The primary efficacy endpoint was a reduction of at least five points in the IHS4 score from baseline after 12 weeks of treatment. Secondary assessments included comparison of mean IHS4 scores at the end of treatment and evaluation of treatment response according to demographic characteristics.

The study was approved by the Institutional Research and Ethical Review Board of Medical Teaching Institution-Hayatabad Medical Complex, Peshawar (Approval No. 1772), and written informed consent was obtained from all participants before enrollment. Data were analyzed using standard statistical methods with statistical significance defined as a two-sided p-value of 0.05 or less. The results are expected to provide comparative evidence regarding the effectiveness of apremilast and acitretin for the management of moderate-to-severe hidradenitis suppurativa and to inform future clinical practice and research.

Inclusion Criteria:

• Adults aged 18 to 40 years.
• Clinically diagnosed moderate hidradenitis suppurativa (International
• Hidradenitis Suppurativa Severity Score System [IHS4] score 4-10) or severe hidradenitis suppurativa (IHS4 score ≥11).
• Able and willing to provide written informed consent.
• Willing to comply with study visits and treatment for 12 weeks.

Exclusion Criteria:

• Pregnancy.
• Previous severe hypersensitivity or adverse reaction to apremilast or acitretin.
• Refusal or inability to provide written informed consent.
• Diabetes mellitus.
• Severe depression.
• Dyslipidemia.
• Severe hepatic impairment.
• Severe renal impairment.