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<p>Acquired dermal macular hyperpigmentation (ADMH) represents a group of pigmentary disorders including lichen planus pigmentosus, erythema dyschromicum perstans, and pigmented contact dermatitis, that cause cosmetically distressing, treatment-refractory dermal pigmentation. Isolated case reports document the efficacy of JAK inhibitors in this condition. The objective of this study was to evaluate the efficacy and safety of oral tofacitinib in patients with ADMH. We conducted a single-centre, open-label, 24-week pilot study at a tertiary dermatology unit in India. Adults with clinical and histopathological evidence of ADMH involving the face and/or neck were enrolled. Participants received oral tofacitinib 5&#xa0;mg twice daily. The primary endpoint was the change in Dermal Pigmentation Area and Severity Index (DPASI). Secondary endpoints included responder rates (≥ 25% or ≥ 50% DPASI reduction), patient self-assessment (0–10 numerical scale), and safety. Of 25 patients recruited, 22 completed the study. Median DPASI declined from 20.3 at baseline to 12.6 at week 24, with significant improvement evident from week 4 onward (<i>p</i> &lt; 0.01). A reduction of ≥ 50% was achieved in 4 patients (16%), while ≥ 25% improvement was observed in 12 patients (48%). None of the patients who failed to achieve at least 25% reduction in DPASI by week 12 reached ≥ 50% responses at week 24. Patient-reported improvement correlated strongly with objective DPASI reduction (ρ = 0.91, <i>p</i> &lt; 0.001). Adverse effects were mild and none required discontinuation. In conclusion, this hypothesis-generating pilot study demonstrates that oral tofacitinib produced modest but significant improvement in ADMH, with no serious adverse events within the 24-week observation period. While dramatic responses were uncommon, early improvement predicted long-term benefit. JAK inhibition warrants further controlled evaluation as a novel therapeutic strategy for this challenging disorder. <i>Clinical trial registration</i>: Clinical Trial Registry of India (CTRI/2024/03/064633).</p>

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Oral tofacitinib for acquired dermal macular hyperpigmentation: results from a 24-week prospective pilot study

  • 期刊论文

  • 发表日期：

    2026年8月3日

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  • Hitaishi Mehta,
  • Anuradha Bishnoi,
  • Keshavamurthy Vinay,
  • Muthu Sendhil Kumaran,
  • Davinder Parsad

摘要

Acquired dermal macular hyperpigmentation (ADMH) represents a group of pigmentary disorders including lichen planus pigmentosus, erythema dyschromicum perstans, and pigmented contact dermatitis, that cause cosmetically distressing, treatment-refractory dermal pigmentation. Isolated case reports document the efficacy of JAK inhibitors in this condition. The objective of this study was to evaluate the efficacy and safety of oral tofacitinib in patients with ADMH. We conducted a single-centre, open-label, 24-week pilot study at a tertiary dermatology unit in India. Adults with clinical and histopathological evidence of ADMH involving the face and/or neck were enrolled. Participants received oral tofacitinib 5 mg twice daily. The primary endpoint was the change in Dermal Pigmentation Area and Severity Index (DPASI). Secondary endpoints included responder rates (≥ 25% or ≥ 50% DPASI reduction), patient self-assessment (0–10 numerical scale), and safety. Of 25 patients recruited, 22 completed the study. Median DPASI declined from 20.3 at baseline to 12.6 at week 24, with significant improvement evident from week 4 onward (p < 0.01). A reduction of ≥ 50% was achieved in 4 patients (16%), while ≥ 25% improvement was observed in 12 patients (48%). None of the patients who failed to achieve at least 25% reduction in DPASI by week 12 reached ≥ 50% responses at week 24. Patient-reported improvement correlated strongly with objective DPASI reduction (ρ = 0.91, p < 0.001). Adverse effects were mild and none required discontinuation. In conclusion, this hypothesis-generating pilot study demonstrates that oral tofacitinib produced modest but significant improvement in ADMH, with no serious adverse events within the 24-week observation period. While dramatic responses were uncommon, early improvement predicted long-term benefit. JAK inhibition warrants further controlled evaluation as a novel therapeutic strategy for this challenging disorder. Clinical trial registration: Clinical Trial Registry of India (CTRI/2024/03/064633).