Larsen HK, et al. - An exploratory scrutiny was conducted of the safety and the efficacy of ingenol mebutate gel 0.05% in patients with anogenital warts (AGW). The findings shed light on the connection between ingenol mebutate gel with a high number of adverse events (AEs) and withdrawals, owing to the painful local and adjacent skin reactions. It exhibited promising efficacy in reducing AGW, irrespective of a difficult-to-treat cohort. A necessity arose for optimisation of the formulation with the intention of improving the safety profile of the treatment.

Methods

• The scheme of this research was an exploratory, open-label, 1-arm trial.
• Herein, patients with AGW were administered ingenol mebutate gel 0.05% up to 3 times.
• The occurrence and severity of local skin reactions (LSRs) and treatment-related adverse events (AEs) inspected the safety.
• An evaluation was carried out of the efficacy by complete clearance and reduction in AGW count 14 days after last treatment, and recurrence 12 weeks after clearance.

Results

• Among the recruited 41 patients, 40 received treatment and 26 completed the trial.
• A median AGW count of 11.0 and AGW duration of 3.0 years was reported by the patients, at baseline.
• Transient LSRs were experienced by all the patients, following treatment with a maximum composite LSR score of 7.5 (on a scale from 0-18).
• Treatment-related AEs were discovered in 93% of the patients.
• The most common AE was pain (85%) and procedural complications (35%) due to smearing of the gel.
• 78% of patients took mild analgesics for the pain, typically for 1-2 days following treatment.
• The intensity of a majority of the AEs were moderate to severe.
• 17/39 patients (43.6%) displayed complete clearance 14 days after last treatment, and AGW count was reduced by 90.9%.
• A tendency towards lower clearance rate was disclosed in patients with longer duration of AGW.
• 14/8 patients (57.1%) reported AGW recurrence, 12 weeks after clearance.