Abstract
About this talk
Background: Atopic Dermatitis (AD) is a chronic inflammatory skin disorder affecting millions globally, with substantial economic and quality-of-life burdens, particularly in low- and middle-income countries like India. While Topical Corticosteroids (TCS), calcineurin inhibitors (e.g., tacrolimus), and non-steroidal agents (e.g., crisaborole) are standard for mild-to-moderate AD, direct comparative data on efficacy, safety, and cost-effectiveness remain limited, hindering informed prescribing.
Materials and Methods: This randomised, open-label, active-controlled trial enrolled 90 patients (aged ≥2 years) with mild-to-moderate AD (Investigator's Global Assessment [IGA] score 2–3) at a tertiary care centre in India (CTRI/2024/05/066965). Participants were randomised 1:1:1 to once-daily tacrolimus ointment (0.03% for <15 years; 0.1% for ≥15 years), crisaborole 2% ointment, or mometasone furoate 0.1% ointment, plus standardised emollient. Assessments occurred at baseline, week 2, and week 4. Primary outcome: proportion achieving IGA success (score 0/1). Secondary outcomes: changes in IGA, Peak Pruritus Numerical Rating Scale (PP-NRS), Eczema Area and Severity Index (EASI), SCORing Atopic Dermatitis (SCORAD), EuroQol-5D-5L (EQ-5D-5L) for quality-adjusted life years (QALYs), adverse events (AEs; MedDRA-coded), and rescue therapy needs. Economic analysis calculated incremental cost-effectiveness ratio (ICER) per IGA success and incremental cost-utility ratio (ICUR) per QALY, using direct drug costs and Indian EQ-5D-5L values. Non-parametric tests (Kruskal-Wallis, Chi-square) were used; p<0.05 was considered significant.
Results: At week 4, IGA success rates were 66.7% (tacrolimus), 60.0% (mometasone), and 50.0% (crisaborole; p=0.48). Median reductions: EASI 2.0 (all arms), PP-NRS 4.0 (tacrolimus) vs. 3.0 (others), SCORAD 15–18 points (p>0.05 across groups). EQ-5D-5L utility improved by 0.068–0.072 QALYs (p<0.001 within groups). AEs were mild/transient (burning most common: 16.7% tacrolimus vs. 6.7% others; p=0.18); no serious events. Rescue therapy: 3.3% (tacrolimus/mometasone). Mometasone cost ?240/patient (60% success), dominating crisaborole (?390; 50% success). Tacrolimus (?598) yielded ICER ?5,343/additional success vs. mometasone; ICUR ?308,621/QALY (1.19× India's GDP/capita threshold).
Conclusion: Tacrolimus, crisaborole, and mometasone demonstrated comparable short-term efficacy and safety in mild-to-moderate AD. Mometasone offers superior cost-effectiveness, supporting its first-line use in resource-limited settings, while tacrolimus suits steroid-sparing needs. Longer-term studies are warranted for maintenance outcomes.
Speaker
About the speaker
