June 2025 digest

Reclaiming Treatment Success in Atopic Dermatitis:
Patients Matter Most

In the evolving landscape of atopic dermatitis (AD) therapeutics, we are witnessing a striking paradox: never have so many therapies been available, yet patient dissatisfaction remains high. Why? Because the metrics guiding clinical trials and regulatory approvals often diverge sharply from what patients truly value. A rigid reliance on statistical significance, severity scores based on visible inflammation, and arbitrary response thresholds (e.g., 50%, 75%, 90% improvement) has created a disconnect between clinical trial “success” and real-world relevance. This gap urgently calls for a shift toward genuinely patient-centered outcome measures.

In a recent editorial in the Indian Journal of Dermatology, Gupta makes a compelling argument for rethinking treatment success in terms of clinical meaningfulness.

He highlights the importance of anchoring outcomes in patient-reported metrics, as initiated in vitiligo research—a field particularly relevant in India—and advocates for prioritizing Substantial Clinical Benefit (SCB) over Minimal Important Difference (MID). In AD, this reframing is especially urgent. Common endpoints like EASI-75 may be statistically rigorous, but they poorly reflect what patients prioritize: itch relief, sleep quality, speed of onset, ease of use, and safety.

A systematic review by Pinborg et al. DOI: 10.1111/jdv.20753 exposes a critical, often overlooked issue: bias in preference research itself. Of 42 studies reviewed, efficacy was consistently rated as the top treatment attribute—largely in pharma-sponsored studies, particularly those funded by manufacturers of Janus kinase inhibitors (JAKi). Alarmingly, these studies often showed patients willing to accept significant risks (e.g., infections) for variable improvements in efficacy, raising concerns that sponsor influence, rather than true patient priorities, may be shaping outcomes. In contrast, non-industry-funded studies emphasized tolerability, safety, and topical treatment attributes—factors closely tied to adherence and long-term quality of life, yet frequently undervalued in trial designs.

This dual insight—that traditional trials often ignore what matters most to patients, and that preference studies may be structurally biased—poses a challenge for both academic dermatology and the pharmaceutical industry. How can we champion “patient-centered care” if we systematically overlook the patient’s voice in defining success?

Looking ahead, it is critical that researchers, regulators, and industry stakeholders adopt validated, standardized, and patient-informed endpoints. Comparisons between therapies should be made using tools anchored in patient-reported outcomes (PROs). Methodological transparency and independence in preference research are essential. Broader use of qualitative methods—such as open-ended interviews and real-world longitudinal studies—can help capture the full diversity of treatment goals. This is particularly important in underrepresented populations, such as Black patients with AD, where erythema is poorly captured and skin dryness often overlooked. Clinical trials must move beyond asking whether treatments work—to asking whether they work enough to matter.

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