SAT0450 Rituximab in Systemic Sclerosis. Results of an up to Seven Years, Open Label, Multicenter Study with a Follow-up of 89 Patient-Years

Abstract

BackgroundWe have previously shown that rituximab (RTX) may favorably affect lung function and skin fibrosis in patients with systemic sclerosis (SSc).ObjectivesTo assess long term data on efficacy and safety of RTX in SScMethodsThirty patients with SSc were recruited from three rheumatology departments. Patients were treated at baseline, 6, 12 and 18 months. Beyond two years, retreatment with RTX was decided by the treating physician. Follow-up data exist for 30, 16, 13, 6 and 4 patients at 1, 2, 3, 5 and 7 year time points, respectively.ResultsPatients were predominantly female (n=22) with a median age of 56 and median disease duration of 4 years. Data from serology, concomitant treatment, skin involvement, PFTs, transthoracic echocardiogram, high resolution lung CT and undesirable effects were recorded. FVC showed significant improvement at 1 year compared to baseline (mean ± SEM: FVC: 83.5±3.4 vs 78.2±3.6 respectively, p<0.001), with a further significant improvement at 2 years (86.2±5.5 p=0.018) and a stabilization thereafter (84.3±6.5 at 5 years, p=0.04). DLco significantly improved at two years compared to baseline (62.4±4.5 vs 57.3±3.2 respectively, p=0.012). Three patients who had initially shown improvement or stabilization of their PFTs with continuous treatment, showed deterioration of PFTs after RTX cessation at three years; these patients did not respond to RTX retreatment later on. Skin thickening (MRSS) improved significantly early (p<0,001 at all time points compared to baseline). During the follow-up period, six cases of respiratory infection requiring hospitalization, one case of hepatitis B reactivation, one case of herpes zoster and two cases of mild infusion reactions were recorded. One patient was diagnosed with lung cancer and another one with prostate cancer. Five deaths were recorded. Two patients died because of end stage respiratory failure, one patient of lung cancer, one of sudden death while the cause of death in the fifth patient is unknown.ConclusionsOur data indicate that continuous treatment with RTX has a beneficial effect on lung function and skin fibrosis in patients with SSc. Treatment was generally well-tolerated. Randomized controlled studies are highly needed.Disclosure of InterestNone declared

Biological Therapy in Systemic Sclerosis

“…Furthermore, in patients with SSc-related However, in three patients who had an initial improvement or stabilisation of lung function with continuous treatment, there was deterioration in the lung function tests after 3 years of rituximab cessation and they did not respond to retreatment. Corroborating previous results, an early improvement in mRSS was also achieved at all time-points compared with baseline (p < 0.001) [65].…”

Translating Autoimmune Pathogenesis into Targeted Therapies for Systemic Sclerosis

“…This was despite demonstrable depletion of B-cells in the periphery and dermis. This pilot study has been followed by a number of studies which support the role of rituximab therapy in SSc [83][84][85][86][87][88][89][90].…”

“…More recently, an open-label, prospective study of 30 SSc patients from three centres added further weight to the evidence base supporting rituximab's use in SSc [90]. Patients received four cycles of rituximab therapy over 18 months, followed by consideration for further cycles by their treating physician.…”