A single-center, open-label, prospective pilot study of subcutaneous efalizumab for oral erosive lichen planus.

Objective: To evaluate the efficacy of efalizumab in the treatment of oral erosive lichen planus.

Design: A single-center, open-label, prospective pilot study. The primary efficacy outcome measure was the change in oral mucosal surface area involvement after 12 weeks of treatment. Secondary outcome measures included the 100-mm visual analog scale (VAS) for pain and a modified Oral Health Impact Profile (OHIP-14) questionnaire.

Results: Four adult patients with oral erosive lichen planus were enrolled and treated with efalizumab 0.7 mg/kg subcutaneously at week 0 followed by 1.0 mg/kg weekly from week 1 to week 11. The mean reduction in the affected mucosal surface area was 71.1% (range 57.3% to 96.8%). The mean improvement in the 100-mm VAS for pain was 82%. The mean improvement in the OHIP-14 questionnaire was 69.3%. Significant adverse events included hospitalization for urticaria and a staphylococcal abscess of an artificial hip joint in one patient and drug-induced subacute cutaneous lupus in another patient.