Adalimumab Use in Severe Recalcitrant Vulval Lichen Sclerosus and Vulval Lichen Planus

Objectives This case series aims to evaluate the demographic features, disease characteristics, and treatment outcomes of 8 patients receiving subcutaneous (SC) adalimumab for severe, refractory vulval lichen sclerosus (VLS) and/or vulval lichen planus (VLP). Both conditions are chronic inflammatory dermatoses that significantly impair quality of life, and although first-line treatment typically involves potent to ultrapotent topical corticosteroids, managing severe cases is challenging due to a lack of FDA-approved systemic therapies. Adalimumab, a TNF-α inhibitor, may offer a promising alternative by targeting the inflammatory cytokine implicated in the pathogenesis of both conditions. Methods Eight patients received SC adalimumab for VLS and/or VLP at a tertiary referral vulvar disorders clinic from September 2020 to June 2024. Among the 8 patients, 4 had VLS/VLP clinical overlap, 2 had VLP, and 2 had VLS. Evaluation included patient-reported outcome measures (PROMs) namely the vulval life quality index (VLQI) and numerical rating scales for itch and pain, and objective clinical severity was assessed by a vulvar dermatologist based on cutaneous signs and architectural features. Results Adalimumab was well tolerated by 6 of 8 patients who received treatment for at least 9 months. Varying degrees of clinical improvement were observed in cutaneous signs and PROMs, including significant reductions in vulval life quality index scores for 6 patients. Architectural changes remained stable throughout treatment for all patients. Conclusion This case series indicates that SC adalimumab may be a treatment option for patients with severe, refractory VLS and VLP, as demonstrated by significant improvements in PROMs. The observed clinical benefits suggest that adalimumab targets key inflammatory pathways in these conditions. Controlled trials are necessary to further validate these findings and define adalimumab's role in managing severe refractory VLS and VLP. Future research should also investigate long-term efficacy and safety, as well as potential predictors of treatment response, to optimize care for this challenging patient population.