Abstract
Purpose: :
To assess the efficacy and patient tolerance of a validated regime of pulsed intravenous immunosuppression consisting of cyclophosphamide and methylprednisolone originally established for the treatment of systemic vasculitides, in cases of severe ocular inflammatory disease refractory to conventional therapy.
Methods: :
Patients with refractory ocular inflammation presenting to a large tertiary referral ophthalmology unit in the UK between 2002-2008 were retrospectively reviewed. All patients were commenced on a protocol of pulsed cyclophosphamide (15mg/kg) and methylprednisolone (10mg/kg) administered intravenously at a dosing interval regimen of 0, 2 ,4, 7, 10 and 13 weeks. Further pulses were administered monthly dependent on clinical response. Following implementation of this protocol, ‘success’ was defined as complete remission of inflammation with the patient maintained on steroid-sparing agents for a minimum of 3 months, ‘partial success’ as incomplete remission, and ‘failure’ as no response or withdrawal of therapy due to adverse effects or toxicity. Outcome measures were assessed at 6, 12 and 18 months following commencement of the regimen.
Results: :
Twenty-one consecutive patients (33 eyes (20 uveitis, 13 scleritis/ sclerokeratitis) male:female 8:13), aged 50 (39-57) years (median (IQR)) were identified. A median of 6 (IQR 5-7) pulses were administered over 3 (2-4) months (median (IQR)). Follow-up data was available for 33 (100%) eyes at 6 months, 30 (91%) eyes at 12 months and 24 (73%) at 18 months. Of these eyes 18/33 (55%) achieved success or partial success at 6 months, 17/30 (57%) at 12 months and 12/24 (50%) at 18 months. Significantly higher success rates were seen within the scleritis/ sclerokeratitis group compared with the uveitis groups at 6, 12 and 18 months follow up (Fisher’s exact test p<0.001, p<0.01 and p<0.05; and Χ2 adjusted for binocular involvement p<0.01, p<0.05 and p<0.05, respectively). One patient had treatment withdrawn due to adverse-effects.
Conclusions: :
Pulsed cyclophosphamide and methylprednisolone regime is efficacious and generally well-tolerated, in patients with refractory ocular inflammation. It appears to be particularly effective in cases of scleritis or sclerokeratitis.
Keywords: uveitis-clinical/animal model • immunomodulation/immunoregulation • corticosteroids