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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

Background:Tofacitinib is an oral Janus Kinase inhibitor for the treatment of rheumatoid arthritis (RA).Objectives:To evaluate the three-year effectiveness of tofacitinib in RA conventional synthetic (cs) DMARDs non-responders.Methods:Data from 374 patients from Russian national register OREL of patients with RA treated with tofacitinib not less than 3 years after failure of conventional DMARDs were included in the statistical analysis. Clinical and laboratory data from 4 consecutive visits with an interval of 12 months between the visits (± 28 days) were analyzed. Treatment with any biologics ever was an exclusion criteria. Demographical (age, sex) and disease-related characteristics of RA (symptoms duration, RF- and ACCP positivity, presence of joint erosions, DAS28, CDAI, number of tender and swollen joints (NTJ, NSJ), erythrocytes sedimentation rate (ESR), C-reactive protein (CRP)) collected. Statistical analysis performed with statistical programs SPSS2017 and GraphPadPrizm. p-value < 0.05 considered as significant.Results:Baseline characteristics of RA patients, involved in the analysis are presented in table 1.Table 1.Baseline characteristics of the patients with RA (n=374).ParameterCharacteristicsMale, n (%)92 (24.5)Age, years (mean±SD)53.4±13.38Symptoms duration, month (mean±SD)140±137Positive rheumatoid factor (RF), n (%)123(32.8)Positive antibodies to cyclic citrullinated peptide (ACCP), n (%)329(87.9)Erosions of hand joints (X-rays), n (%)372 (99.4)BMI, kg/m2(mean ±SD)26.8 ± 6.14Smokers (current and in the past), n (%)54 (14.4)Changes in the diseases activity parameters in patients with RA, treated with tofacitinib not less than 3 years after cs DMARD failure are presented in table 2, figure 1, and figure 2.Figure 1.DAS28 of patients with RA, treated with tofacitinib (n=374) – 3-years follow-up (time-points are presented in years ± 28 days).Figure 2.DAS28 of patients with RA, treated with tofacitinib (n=374) – 3-years follow-up (time-points are presented in years ± 28 days).Table 2.Changes in RA parameters in patients treated with tofacitinib, n=374 (M±SE).Disease characteristicsBaselineYear 1#Year 2#Year 3#C-RP, mg/L30.1±35.08.3±12.87.6±10.79.4±13.5ESR, mm/h35.2±21.222.7±17.221.9±17.722.3±17.3NTJ from 2811.2±6.54.6±4.94.8±5.03.9±3.8NTJ from 287.6±5.12.4±3.21.7±3.11.4±2.8*difference with baseline is significant with p#- ±28 daysConclusion:According to the real world data treatment with tofacitinib may provide good response rates in RA patients, refractory to the previous csDMARDs treatment in long-term perspective.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, Andrey Baranov Grant/research support from: Bayer, Galina Lukina Speakers bureau: Novartis, Pfizer, UCB, Abbvie, Biocad, MSD, Roche, Evgeniy Zhilyaev Speakers bureau: Novartis, UCB, Pfizer, Biocad, Abbvie, MSD, Roche, Ekaterina Koltsova: None declared, Evgeniya Shmidt Speakers bureau: MSD, Novartis, Pfizer, Oxana Fomina: None declared, Irina Bondareva: None declared, Olga Anoshenkova: None declared, Aleksey Vasilenko: None declared, Elizaveta Vasilenko: None declared, Natalya Yudina: None declared, Larisa Knyazeva: None declared, Vyacheslav Poncratov: None declared, Ekaterina Gaydukova: None declared, Evgeny Nasonov Speakers bureau: Lilly, AbbVie, Pfizer, Biocad, R-Pharm

Background:Due to current data mean diagnostics delay in axial spondyloarthritis (axSpA) is 7.4 ± 8.4 years (mean ± SD) [1]. However, development of specific and high sensitive criteria of axSpA do not improve the situation because one of the main reasons of late axSpA diagnostics is the increased period when the patient with typical axSpA symptoms do not referred by general practitioner (GP) to the rheumatologists (so called «human factor»). The increasing role of internet online technologies can make way from GP to rheumatologist shorter and decrease the diagnostics delay in axSpA.Objectives:To develop the online questionnaire that calculates probability of having axSpA and evaluate the advantages of the method of online based detection of axSpA under the traditional ways of axSpA search.Methods:Based on positive and negative predictive values of symptoms from ASAS axSpA criteria (2009) the axSpA Early Diagnostics Questionnaire (aEDQ) was developed. The aEDQ was available on website of Russian Ankylosing Spondylitis Association from October 2018. Link to the aEDQ could be obtained directly on the site and additionally by using one of 1,500 related to axSpA keywords approved by 5 rheumatologists from Russian SpA Expert Group. Those of participants who had high risk of axSpA according aEDQ were recommended to visit the rheumatologist, related to axSpA diagnostics. Participants with low risk of axSpA were sent to their GP. Collected data of diagnostics delay and capacity of the aEDQ were compared with data from demographically matched populations from EMAS online survey from 13 European countries (n=2,846), and SPACE cohort results (n=461) [1, 2], and from Russian North-Western axSpA LADOGA register (n=1,544). This study used only anonymized data. Statistical analysis was performed with Statistica SPSS2017, GraphPadPrizme 2016.Results:Since October 2018 until January 2019 in Saint-Petersburg 22,925 people visited the aEDQ, 21,939 (95.6%) people filled out the questionnaire. Out of 21,939 people filled out questionnaire 7,888 (35.95%) people has high risk of axSpA. Within one month after passed the questionnaire 424 people with high risk of axSpA (5% out of all who had the recommendation) consulted by rheumatologist (mean age 42±6.6 years, male 275 (65%), symptoms duration 4.4 ± 3.0 years, HLA-B27 positive 292 (68.3%)). In 254 patients out of 424 (59.9%) presence of axSpA was confirmed as compared with 44.6% in SPACE cohort results (χ2 = 19.24, pMean diagnostics delay in aEDQ cohort was 4.4 ± 3.0 years (mean ± SD), n = 254, in axSpA patients with traditional way of axSpA search in LADOGA register was 8.8 ± 4.8 years, n=1,544 (LADOGA study results), and 7.4 ± 8.4 years in EMAS survey [1], p < 0.0001 for all the differences.Conclusion:Online axSpA Early Diagnostics Questionnaire with function of calculation of axSpA probability can decrease diagnostics delay and increase percentage of confirmed by rheumatologist axSpA diagnosis as compared with another forms of axSpA search.References:[1]Garrido-Cumbrera M, EMAS Working Group. Curr Rheumatol Rep. 2019; 21(5): 19. doi: 10.1007/s11926-019-0819-8[2]Poddubnyy D, et al. RMD Open. 2018 Dec 5;4(2):e000825. doi: 10.1136/rmdopen-2018-000825. eCollection 2018.Acknowledgments:Alexey SitaloDisclosure of Interests:Ekaterina Gaydukova: None declared, V Mazurov: None declared, Oxana Inamova: None declared, Elizaveta Vasilenko: None declared, Inna Gaydukova Grant/research support from: JSC BIOCAD, Speakers bureau: Pfizer, Novartis, AbbVie, JSC BIOCAD, Сelgene, MSD, Sanofi

Background Inflammatory back pain (IBP) is one of the main presenting symptoms in spondyloarthropathies (SpA). The prevalence of inflammatory back pain in young people population is unknown. The identification of chronic IBP, starting before age 45 can help diagnose SpA early. Objectives To determine the prevalence of chronic low back pain and inflammatory back pain in a cohort of young people. Methods Students were asked to fill out the questionnaire containing questions about low back pain, symptoms duration, all relevant inflammatory back pain parameters (according Calin and ASAS IBP criteria). Overall 3480 questionnaires were completed. Results The average age of respondents was 24±4,75 years; 76,35% of respondents were females. 1744 (50,1%) students reported having at least one episode of low back pain. 10,3% of all respondents (358), had chronic back pain. From 2657 interviewed 10,6% females had chronic low back pain, from 823 males 9,2%. 72 students (2, 1%) fulfilled ASAS IBP criteria, 48 (1.8%) females, 24 (2.9% males) respectively.101 (2,9%) respondents were defined as suffering inflammatory back pain according Calin criteria, 73 (2,7%) females and 28 (3.4%) males. The difference between prevalence of IBP among genders was not statistically significant. Conclusions In our study prevalence of inflammatory back pain among young people cohort was 2,1-2,9%, prevalence of chronic back pain – 10,3%. The data suggest that prevalence of inflammatory back pain did not differ significantly between young men and women. Acknowledgements Sieper, J. et al . New criteria for inflammatory back pain in patients with chronic back pain: a real patient exercise by experts from the Assessment of SpondyloArthritis international Society (ASAS). Ann. Rheum. Dis. 68, 784–788 (2009). Calin, A. et al . Clinical history as a screening test for ankylosing spondylitis. JAMA 237 , 2613–2614 (1977). Disclosure of Interest None Declared