Dear Sir,
We read with great interest the article by Anil et al. entitled “Efficacy and safety of different doses of apremilast in mild to moderate psoriasis” published in a recent issue of the Indian Journal of Pharmacology.[1] We congratulate the authors for conducting a well-designed randomized controlled trial that provides valuable evidence regarding dose optimization of apremilast in patients with mild-to-moderate psoriasis.
We would, however, like to offer a few observations that may further enrich the interpretation of the study findings.
Although the primary efficacy outcomes, including Psoriasis Area and Severity Index (PASI) 50, PASI 75, PASI 90, static Physician Global Assessment (sPGA) 0/1, and Psoriatic Arthritis Response Criteria, were reported to be comparable between the apremilast 30 mg twice daily and 20 mg twice daily groups, certain numerical differences appear clinically noteworthy. As shown in Table 2, PASI 90 was achieved in 24.4% of patients receiving 30 mg twice daily compared with 16.7% of those receiving 20 mg twice daily. Likewise, a sPGA score of 0/1 was observed in 39.0% versus 30.6% of patients, respectively. Although these differences did not reach statistical significance, they may become clinically meaningful in studies with a larger sample size or longer follow-up, where adequate statistical power could better detect differences in higher levels of disease clearance.
The overall incidence of adverse events reported in the present study was approximately 39%, which appears higher than that observed in the pivotal Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis (ESTEEM)-1 and ESTEEM-2 phase III trials evaluating apremilast in psoriasis.[2,3] While variations in patient characteristics, study design, and adverse event reporting may account for these differences, a brief discussion comparing these findings with previous landmark trials would have strengthened the interpretation of the safety data.
Psoriasis is a chronic disease with substantial physical, psychological, and social consequences. Therefore, assessment of patient-reported outcomes and quality-of-life measures is an important component of therapeutic evaluation. Previous studies have demonstrated that apremilast significantly improves the Dermatology Life Quality Index, Patient Health Questionnaire-8, and work productivity outcomes in addition to clinical efficacy.[4] Inclusion of such validated quality-of-life measures in future studies, particularly those with longer treatment duration, would provide a more comprehensive assessment of the overall benefits of therapy.
Despite these observations, we appreciate the authors for demonstrating that apremilast 20 mg twice daily offers efficacy and safety comparable to the standard 30 mg twice daily regimen, while the 10 mg twice daily dose appears inadequate. These findings have important practical implications, particularly in situations where dose reduction may be considered because of tolerability or cost concerns. We believe that this study contributes meaningfully to the existing literature and will assist clinicians in making informed therapeutic decisions for patients with psoriasis.
Conflicts of interest
There are no conflicts of interest.
Funding Statement
Nil.
References
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