Oral Tofacitinib versus Azathioprine in the Management of Chronic Actinic Dermatitis – An Open Randomized Clinical Trial

Abstract Background: Chronic actinic dermatitis (CAD) is an immunologically mediated photodermatosis characterized by pruritic eczematous and lichenified plaques located predominantly on sun-exposed areas with notable sparing of eyelids, skin folds, and postauricular skin. Tofacitinib is a Janus kinase inhibitor, and azathioprine is a purine analog. This study aimed to compare the role of tofacitinib versus azathioprine in the management of CAD. Aim and Objectives: To compare the efficacy and tolerability of tofacitinib versus azathioprine in the management of CAD. Patients and Methods: The study involved 30 patients above 18 years of age diagnosed with CAD. Group A received azathioprine 100 mg daily with topical emollients, while group B received oral tofacitinib 5 mg twice daily with topical emollients, both for 90 days. Efficacy was assessed using Eczema Area Severity Index (EASI) score and photographic analysis, with 50% reduction in EASI (EASI50) as the endpoint. Results: There was a 30.85% reduction in the mean EASI score in the azathioprine group as compared to 57.2% in the tofacitinib group (P=0.018). In the tofacitinib group, 80% of patients achieved the primary endpoint of EASI50, compared to 20% of patients achieving the same in the azathioprine group. Adverse effects were reported more in the azathioprine group as compared to the tofacitinib group ( P = 0.003). Limitations: A small sample size, lack of assessment of improvement in quality of life, and the patients were followed up for 90 days only. Conclusion: Tofacitinib is more efficacious and better tolerated than azathioprine in the management of CAD.