AB0728 Comparative results of long-term (for 36 months) use of rituximab and immunosuppressants in patients with systemic scleroderma with interstitial lung disease in real clinical practice

Abstract

BackgroundImmunosuppressants (IS) is considered as a drug of choice for the treatment of interstitial lung disease (ILD) in the patients with systemic sclerosis (SSc). However, the IS use leads to rather limited and transient improvement of the pulmonary fibrosis. In this context the search for novel, more efficacious agents have been continued, such as attracting much attention rituximab (RTM).ObjectivesTo compare the dynamics of pulmonary function parameters and skin fibrosis in patients with SSc associated with ILD, who received RTM and IS for 3 years in real clinical practice.Methods158 pts with the SSс-ILD were enrolled into the study. All pts received low- and moderate-dose glucocorticoids regimens. Group A (n=100) received IS’s (31/31% mycophenolate mofetil, 27/27% cyclophosphamide, 15/15% methotrexate; 27/27% other drugs; the patient’s average age was 49.5±12.2 years, with female proportion 87%; SSc duration 8.6±7.2 years; diffused/localized forms 1/ 2.8). Group B (n=58) received RTM a total dose 3.0±1.2 g, 22 patients received RTM in combination with ISs (11/19% mycophenolate mofetil, 11/19% cyclophosphamide; average age 48.0±13.2 years, female proportion 86%, SSc duration 6.4±4.9 years, diffused/localized forms 1.5/1). The therapy duration in both groups was 36 months. The time courses of forced vital capacity (FVC), diffusive lung capacity (DLC), modified skin count (mRss, points), activity index (EScSG, points), HAQ were assessed in the study.ResultsIn Groups A and B the therapy was associated with significant decrease in mRss and stabilization of the diffusive lung capacity. During the follow-up period in Groups A no change of the other studied parameters was observed.In Groups B the therapy was associated with significant decrease in HAQ and EScSG.Evaluation of FVC time course in Group B revealed significant FVC increase with median increment about 5.6%. In Group B 10% FVC increase was found in the third of the patients thus exceeding respective parameter in Group B (16%). The patient percentage with FVC decrease by ≥10% in group B was less common compared to group A.During RTM therapy it was possible to significantly reduce the dose of glucocorticoids.RTM and immunosuppressants administration for 36 months in the patients with SSc and ILD effectively alleviated skin induration and stabilized DLCO.Table 1.ParametersGroup Аn=100Group Вn=58рFVC1 M ± SD95.2±17.0Р=0.376.8±20.7P=0.0003FVC1 M ± SD96.5±18.983.8±22.2Δ FVC %, SD’S [25%’S; 75%’S]-0.7 [-5.8; 7,9]5.6 [-1.9;14.8]0.008DLCO 1, M ± SD62.6±19.9Р=0.0846.4±18.3P=0.6DLCO 2, M ± SD60.1±17.447.1±17.6Δ DLCO %-1.7 [-5.9;3.3]1.25 [-4; 7.05]0.15mRss, 1 M ± SD5.6±5.3P=0.00311.3±10.2P=0.000013mRss, 2 M ± SD4.3±3.75.5±4.8Δ mRss, SD’S [25%’S; 75%’S]0 [-2;0]-3 [-11;0]0.000031HAQ10.86±0.5P=0.91.14±0.8P=0.01HAQ20.86±0.60.9±0.8EScSG 1, M ± SD1.64±1.2P=0.42.6±P=0.0005EScSG 2,M ± SD1.8±1.31.4±Dose of glucocorticoids 1, mg8.8±4.8P=0.1611.4±4.0P=0.002Dose of glucocorticoids 2, mg8.1±3.79.1±2.9FVC increment by ≥10%, n/%16/1617/29.30.04FVC decrement by ≥10% n/%14/144/6.70.18DLCO increment by ≥10%, n/%6/65/8.60.5DLCO decrement by ≥10% n/%14/145/8.60.31 = before treatment, 2 = after treatment; M ± SD = mean value and standard deviation; * = significant difference between the vales measured before and after the treatmentConclusionOnly RTM significantly improved FVC and the patient’s quality of life and decreased of the activity index. RTM demonstrated a steroid-saving effect. The study findings substantiate potential use of RTM as a first-line agent for the treatment ILD progressive phenotype in SSc. The immunosuppressants use as a single-agent therapy is more preferable in patients with less pronounced ILD.Disclosure of InterestsNone declared