Background:Currently it is unclear whether combination of tofacitinib (tofa) with methotrexate (Mtx) more effective and safe than tofa in monotherapy.Objectives:To compare efficacy and safety of tofacitinib monotherapy with combination of tofa and mtx in RA patients.Methods:Data from 450 patients from Russian national RA register OREL were included in the statistical analysis. Data from the 1st, 6, 12, 24 and 36 month after baseline were analyzed. Demographical and disease-related characteristics of RA (symptoms duration, DAS28, CDAI, SDAI, number of tender and swollen joints (NTJ, NSJ), erythrocytes sedimentation rate (ESR), C-reactive protein (CRP)) were collected. Statistical analysis performed with SPSS2017.Results:Baseline characteristics of RA patients involved in the analysis are presented in table 1. Mean dosage of mtx was 15.5±5.5 mg/week.Table 1ParameterTofa monotherapy, n=169Tofa +Mtx, n=281Male34 (20%)51 (18.14)Age, years53.0±13.349.8±12.8Symptoms duration, month149.7±110.1120.0±96.5Positive rheumatoid factor (RF)126 (75)210 (74.3)Positive antibodies to cyclic citrullinated peptide (ACCP)129 (79)233 (83)p≥0.05 for all the differences.Treatment results are presented in table 2.Table 1.A. Pre-treatment screeningParameter1 month*6 month*12 month*24 month*36 month*n mono123 (72.78)111 (65.68)90 (53.25)48 (28.40)20 (11.83)n combo205 (72.95)222 (79)150 (53.38)69 (24.55)37 (13.16)CDAI mono30.14±12.4514.49±10.7613.08±8.9113.54±5.5311.84±7.89CDAI combo28.27±13.1216.46±10.5812.78±9.519.71±10.6210.61±10.05DAS28 mono5.35±1.163.97±1.303.50±1.13.26±1.003.10±0.89DAS28 combo5.54±1.263.87±1.253.63±1.273.56±1.183.47±1.29SDAI mono30.95±13.9116.84±11.9714.33±11.3910.62±5.7912.95±12.12SDAI combo35.05±14.8915.50±11.1514.04±10.3114.31±10.8712.89±11.39CRP mono, mg/L24.01±26.668.45±11.808.79±14.015.90±5.138.74±10.46CRP combo, mg/L34.48±39.2511.76±22.368.12±12.678.54±14.3510.49±17.51ESR mono, mm/h32.96±17.2622.54±15.4521.26±15.3822.83±21.2421.29±14.02ESR combo, mm/h36.68±22.9824.24±16.8921.59±15.4019,52±12.8322.97±19.36NTJ from 28 mono10.73±6.156.26±4.654.97±5.024.13±3.093.42±4.01NTJ from 28 combo11.75±6.635.21±5.364.55±4.435.73±5.683.45±4.15NSJ from 28 mono8.0±4.782.0±2.942.0±2.641.0±1.300.0±0.45NSJ from 28 combo8.26±5.222,96±3.492.55±3.332.54±4.281.68±3.00*from the baseline ± 14 days for 1 and 6 month, ±28 days for 12, 24, and 36 monthp-value ≥ 0.05 for all the differences between monotherapy and combination therapy in all the time points.No differences were found in safety parameters between groups of tofamonotherapy and tofa plus mtx.Conclusion:The efficacy and safety of tofacitinib monotherapy is not worth than combination of tofacitinib and methotrexate in RA treatment.Acknowledgments:PfizerDisclosure of Interests:Inna Gaydukova Grant/research support from: JSC BIOCAD, Speakers bureau: Pfizer, Novartis, AbbVie, JSC BIOCAD, Сelgene, MSD, Sanofi, V Mazurov: None declared, Alexander Lila: None declared, Diana Abdulganieva: None declared, Svetlana Lapshina: None declared, Leysan Myasoutova: None declared, Irina Vinogradova: None declared, Olga Semagina: None declared, L Solodovnikova: None declared, E Kryukova: None declared, Ekaterina Gaydukova: None declared, N Lapkina: None declared, Diana Kretchikova: None declared, O Epifanova: None declared, Evgeny Nasonov Speakers bureau: Lilly, AbbVie, Pfizer, Biocad, R-Pharm