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Association between Daclizumab and Granulomatous Disease in People with Multiple Sclerosis (MS)
Objectives: To report two cases of granulomatous disease in MS patients who were receiving daclizumab.
Methods: A retrospective review was performed of people with MS who had been treated with daclizumab between 2004 and 2018 in the Johns Hopkins MS clinic. We selected patients with biopsy proven granulomatous disease after treatment exposure. Analysis of the clinical, imaging and pathology characteristics was completed.
Results: Of a total of 22 people with MS treated with daclizumab, two patients developed biopsy proven systemic granulomatous disease. Both patients were previously exposed to other disease modifying treatments (e.g. interferons, glatiramer acetate, natalizumab) and were on daclizumab treatment for 3 and 14 years before the onset of systemic symptoms. The first patient developed persistent thrombocytopenia and was found to have marked splenomegaly, which upon resection revealed multiple non-caseating granulomas but no evidence of extra-splenic involvement. The second case presented with multiple lytic lesions in the skull, one of which was biopsied and showed non-caseating granulomas. This person had a diffusely positive FDG PET showing active cervical, hilar and abdominal lymphadenopathy with multiple bilateral avid pulmonary nodules consistent with active sarcoidosis. Clinical improvement was observed after splenectomy and daclizumab discontinuation in the first case, but given the extensive systemic involvement of the second case, mycophenolate mofetil was started as a disease modifying treatment for both MS and systemic sarcoidosis.
Conclusions: A systemic granulomatous inflammation after medium and long term exposure can be observed in daclizumab treated patients. Now that the medication is in process of market withdrawal, awareness about this unusual and possibly late-onset complication must be kept under surveillance.