Dear Editor,
We read with interest the recent study by Sardana et al.[1] on the use of tofacitinib in Indian patients with refractory atopic dermatitis (AD), including a pediatric cohort as young as five years old. While the attempt to explore economical therapeutic options for this population is commendable, several aspects of the study merit critical examination, particularly its pharmacoeconomic claims, comparator selection, and clinical extrapolations.
The pharmacoeconomic analysis presented by the authors is premature and limited in scope. The eight-week drug cost comparison does not account for the lack of long-term safety data, especially in pediatric off-label use. This is especially concerning given the notable adverse event rate (41.6%), including herpes zoster in a teenager, a complication that may incur additional downstream healthcare costs. Moreover, the cost estimation fails to incorporate the expenses associated with pre-treatment, ongoing laboratory monitoring, and repeat clinical visits, factors that are integral to the safe administration of Janus kinase (JAK) inhibitors. Furthermore, the claim that tofacitinib is “122 times cheaper” than dupilumab is unsupported by any formal health economic modeling such as quality-adjusted life years or incremental cost-effectiveness ratios. Without a sensitivity analysis or societal cost considerations, this figure risks being misleading.
The selection of dupilumab as a comparator also raises issues. The study assumes a branded retail price, with no mention of patient assistance programs or government-subsidized procurement, both of which significantly impact real-world affordability. The implied efficacy equivalence between tofacitinib and dupilumab based on an 8-week eczema area and severity index - 90 (EASI-90) response is particularly problematic. Dupilumab’s efficacy has been validated in phase 3 randomized controlled trials with over 1,500 patients and standardized endpoints,[2] whereas the present study is a retrospective audit of 12 patients. Notably, four of 11 patients (36.3%) relapsed shortly after discontinuing tofacitinib, raising concerns about disease control durability.[1]
Furthermore, the risk-benefit ratio of tofacitinib in children appears inadequately addressed. The dosing regimen (5–15 mg daily) surpasses food and drug administration (FDA)-approved pediatric dosing for autoimmune conditions such as juvenile idiopathic arthritis,[3] yet no weight-based pharmacokinetic rationale or long-term safety monitoring plan is discussed. The extrapolation from its use in alopecia areata is also unconvincing, given the differing immunopathology and systemic inflammatory burden between the two diseases.
The immunological rationale provided, though visually appealing, is conceptually reductive. The assertion that dupilumab is ineffective in Th17/Th22-predominant endotypes does not reflect recent findings, which show that AD phenotypes often overlap, with emerging evidence supporting dupilumab efficacy across endotypes using stratified transcriptomic and proteomic markers.[4] In contrast, the authors’ suggestion that JAK inhibitors may be broadly superior omits head-to-head data and black-box warnings associated with JAK inhibitors, including the risk of thromboembolism and infection, which demand careful patient selection and routine laboratory monitoring.
In conclusion, we support the need for cost-conscious therapeutic innovation in Indian dermatology but urge caution in interpreting the findings of this study. The pharmacoeconomic conclusions are insufficiently modeled, and the safety profile, especially in children, requires robust justification. Without such critical nuances, there is a risk of premature clinical adoption of unvalidated, off-label regimens.
Conflicts of interest
There are no conflicts of interest.
Use of artificial intelligence (AI)
The preparation of this manuscript was carried out entirely by the author without the use of artificial intelligence technologies.
Funding Statement
Nil.
References
- 1.Sardana K, Sharath S, Meena SK, Khurana A, Dhir B. A real-world study of tofacitinib in Indian patients with refractory moderate-to-severe atopic dermatitis, its economic considerations and immunological rationale. Indian Dermatol Online J. 2025;16:420–5. doi: 10.4103/idoj.idoj_665_24. [DOI] [PMC free article] [PubMed] [Google Scholar]
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