AB0342 EFFICACY AND SAFETY OF TOFACITINIB MONOTHERAPY AND WITH METHOTREXATE COMBINATION. DATA FROM NATIONAL RHEUMATOID ARTHRITIS REGISTER
Authors: I. Gaydukova, V. Mazurov, A. Lila, D. Abdulganieva, S. Lapshina, L. Myasoutova, I. Vinogradova, O. Semagina, L. Solodovnikova, E. Kryukova, E. Gaydukova, N. Lapkina, D. Kretchikova, O. Epifanova, E. Nasonov
Journal: Annals of the Rheumatic Diseases (2020)

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 1 Parameter Tofa monotherapy, n=169 Tofa +Mtx, n=281 Male 34 (20%) 51 (18.14) Age, years 53.0±13.3 49.8±12.8 Symptoms duration, month 149.7±110.1 120.0±96.5 Positive 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 screening Parameter 1 month* 6 month* 12 month* 24 month* 36 month* n mono 123 (72.78) 111 (65.68) 90 (53.25) 48 (28.40) 20 (11.83) n combo 205 (72.95) 222 (79) 150 (53.38) 69 (24.55) 37 (13.16) CDAI mono 30.14±12.45 14.49±10.76 13.08±8.91 13.54±5.53 11.84±7.89 CDAI combo 28.27±13.12 16.46±10.58 12.78±9.51 9.71±10.62 10.61±10.05 DAS28 mono 5.35±1.16 3.97±1.30 3.50±1.1 3.26±1.00 3.10±0.89 DAS28 combo 5.54±1.26 3.87±1.25 3.63±1.27 3.56±1.18 3.47±1.29 SDAI mono 30.95±13.91 16.84±11.97 14.33±11.39 10.62±5.79 12.95±12.12 SDAI combo 35.05±14.89 15.50±11.15 14.04±10.31 14.31±10.87 12.89±11.39 CRP mono, mg/L 24.01±26.66 8.45±11.80 8.79±14.01 5.90±5.13 8.74±10.46 CRP combo, mg/L 34.48±39.25 11.76±22.36 8.12±12.67 8.54±14.35 10.49±17.51 ESR mono, mm/h 32.96±17.26 22.54±15.45 21.26±15.38 22.83±21.24 21.29±14.02 ESR combo, mm/h 36.68±22.98 24.24±16.89 21.59±15.40 19,52±12.83 22.97±19.36 NTJ from 28 mono 10.73±6.15 6.26±4.65 4.97±5.02 4.13±3.09 3.42±4.01 NTJ from 28 combo 11.75±6.63 5.21±5.36 4.55±4.43 5.73±5.68 3.45±4.15 NSJ from 28 mono 8.0±4.78 2.0±2.94 2.0±2.64 1.0±1.30 0.0±0.45 NSJ from 28 combo 8.26±5.22 2,96±3.49 2.55±3.33 2.54±4.28 1.68±3.00 *from the baseline ± 14 days for 1 and 6 month, ±28 days for 12, 24, and 36 month p-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: Pfizer Disclosure 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