Ab0422 the effects of concomitant use of methotrexate in patients with rheumatoid arthritis treated with sarilumab

Background Sarilumab was launched the second interleukin 6 receptor inhibitor (IL-6Ri) as a treatment for patients with rheumatoid arthritis (RA) in Japan. Tocilizumab, that was known as first IL-6Ri, showed excellent therapeutic effect without methotrexate (MTX) for RA. However, it was unknown that the effect on concomitant use of MTX in RA patients treated with sarilumab. Objectives We evaluated the effect on concomitant use of MTX in RA patients treated with sarilumab. Methods This study used a multicenter database included 673 RA patients treated with b/tsDMARDs. We finally analyzed 72 RA patients treated with sarilumab. Thirty-three RA patients were combined with MTX (MTX group) and 39 RA patients were not combined with MTX (non-MTX group). The continuation rate and efficacy at 52 weeks after sarilumab treatment in each group was evaluated. Results Non-MTX group was older, longer disease duration, and lower eGFR than MTX group (Table 1). The continuation rate at 52 weeks was not different between MTX group and non-MTX group (56.4 vs 74.4%, p=0.08). DAS28-CRP, SDAI, CDAI were decreased at 4, 12, 24, 36, 52 weeks after sarilumab treatment compared to baseline in both MTX group and non-MTX group (Figure 1). Improvement rate of DAS28-CRP, SDAI and CDAI at 4, 12, 24, 36, 52 weeks after sarilumab treatment were not different between groups (DAS28-CRP: p=0.36, p=0.53, p=0.56, p=0.46, p=0.29; SDAI: p=0.58, p=0.93, p=0.90, p=0.63, p=0.56; CDAI: p=0.65, p=0.98, p=0.99, p=0.61, p=0.47; respectively). HAQ was not improved in MTX group, but improved in non-MTX group during 52 weeks sarilumab treatment (MTX group, p=0.98; non-NTX group, p=0.04). In all patients, 49 RA patients were treated sarilumab as 2nd and more line biological/ targeted synthetic disease-modifying anti rheumatic dugs (b/tsDMARDs). DAS28-CRP, SDAI and CDAI at baseline in RA patients treated with sarilumab as 2nd and more line b/tsDMARDs were 4.1, 18.9, 16.4 in MTX group (n=23), and 4.6, 24.3, 22.6 in non-MTX group (n=26). DAS28-CRP, SDAI and CDAI were decreased at 4, 12, 24, 36, 52 weeks after sarilumab as 2nd and more line treatment compared to baseline in both MTX group (DAS28-CRP: 3.0, 2.5, 2.5, 2.7, 2.7, p<0.01, respectively; SDAI: 12.5, 9.6, 9.3, 10.6, 10.3, p<0.01, respectively; CDAI: 12.2, 9.4, 9.0, 10.2, 10.1, p<0.01, respectively) and non-MTX group (DAS28-CRP: 3.3, 2.8, 2.8, 2.8, 2.6, p<0.01, respectively; SDAI: 15.6, 11.5, 11.4, 11.1, 9.9, p<0.01, respectively; CDAI: 15.2, 11.1, 11.1, 11.0, 9.7, p<0.01, respectively). Improvement rate of DAS28-CRP, SDAI and CDAI at 4, 12, 24, 36, 52 weeks after sarilumab as 2nd and more line treatment were not different between groups (DAS28-CRP: p=0.99, p=0.96, p=0.83, p=0.94, p=0.53; SDAI: p=0.10, p=0.65, p=0.79, p=0.87, p=0.68; CDAI: p=0.95, p=0.72, p=0.76, p=0.74, p=0.53; respectively). Table 1. Baseline characteristics of RA patients treated with sarilumab MTX (+) group (n=33) MTX (-) group (n=39) p Age (years) 61.51 ± 13.68 69.51 ± 13.12 < 0.01 Male/ Female ratio 10/23 8/31 0.5 Disease durations (years) 9.30 ± 10.22 17.39 ± 11.33 < 0.01 RF positive ratio (%) 81.82 79.49 1.0 CCP positive ratio (%) 77.42 82.86 0.85 CRP (mg/dl) 2.44 ± 2.82 1.90 ± 2.06 0.65 MMP-3 (ng/ml) 271.57 ± 314.38 342.34 ± 327.87 0.047 eGFR 79.78 ± 27.50 58.22 ± 27.52 <0.01 DAS28-CRP 4.23 ± 1.31 4.53 ± 1.0 0.26 SDAI 20.41 ± 12.07 23.17 ± 9.66 0.17 CDAI 17.97 ± 10.71 21.27 ± 9.25 0.08 HAQ 0.78 ± 0.78 1.14 ± 0.88 0.02 MTX (mg/week) 8.58 ± 3.58 0 ± 0 <0.01 Glucocorticoid use (%) 18.18 (6/33) 38.46 (15/39) 0.1 Glucocorticoid dose (mg/day) 7.17 ± 3.19 5.83 ± 3.24 0.37 Number of past use of b/tsDMARD 0 (%) 30.3 33.3 1 (%) 51.5 33.3 2 (%) 12.1 15.4 3(%) 6.1 10.3 4 (%) 0 5.1 5 (%) 0 2.6 Interstitial pneumonia 2/33 7/39 0.17 Conclusion Sarilumab improved disease activity in patients with RA regardless of concomitant use of MTX. REFERENCES: NIL. Acknowledgements: NIL. Disclosure of Interests None Declared.