FRI0149 DISEASE ACTIVITY IN ESCALATION OR DE-ESCALATION OF DOSAGE OF TOFACITINIB IN RHEUMATOID ARTHRITIS PATIENTS – THE FIRST RESULTS OF RUSSIAN NATIONAL REGISTER OF PATIENTS WITH RHEUMATOID ARTHRITIS TREATED WITH TOFACITINIB
Authors: Inna Gaydukova, V Mazurov, Elizaveta Vasilenko, Evgeniy Zhilyaev, Vyacheslav Poncratov, Valentina Sorotskaya, Galina Lukina, Oxana Fomina, Aida Babaeva, N Lapkina, Anna Misiyuk, A Pavlova, Evgeny Nasonov
Journal: Annals of the Rheumatic Diseases (2019)

<h3>Background:</h3> In previous studies tofacitinib (TF) had demonstrated efficacy of two dosages (10 and 20 mg/day) in patients with rheumatoid arthritis (RA). However, the expected results of switching of TF' dosages are unknown. <h3>Objectives:</h3> <b>The aim</b> of the study was to evaluate the results of switching of TF's dosages in RA patients. <h3>Methods:</h3> Were analyzed the data from Russian national register of patients with RA treated with TF (tofacitinib). 415 patients were involved in the register (aug 2018). In statistical analysis were included data from 41 patients with RA (EULAR 2010), who switched dosage of TF at visit 3 and had complete clinical and laboratory data from 5 consecutive visits with an interval of 3 months between the visits. Demographical (age, sex) data, disease activity data DAS28 (Disease activity score), C-reactive protein level were collected, table 1. Changes in disease activity were calculated to patients with switching of the tofa's dosage (the visit before and after the switching). <h3>Results:</h3> 1.28 (68%) of patients were treated with NSAIDs, 24 (50%) with 5-10 mg of prednisolone, 34 (82.9) – with methotrexate (10-25 mg/week), biologics – 5 (4.2%). From 41 persons with RA 32 patients, who never achieved low disease activity (DAS28&lt;3.2) or remission (DAS28&lt;2.6) elevated the dosage of tofa from 10 to 20 mg/day and 9 patients with DAS28 &lt; 3.2 decreased the dosage from 20 to 10 mg/day. After escalation of TF dosage DAS28 decreased from 5.42±1.22 to 4.22±1.22 (p&lt;0.00), n=32. In 10 patients escalation lead to DAS28-remission (DAS28 &lt;2.6) and in 12 patients - to low disease activity (DAS28&lt;3.2). 10 patients had no clinical or laboratory response on escalation of TF dosage. Interestingly, that responders before escalation of dosage had mean DAS28 3.54 (min 3.2 – max 4.9) and non-responders – 5.54 (min 5.3-max 6.9), p&lt;0.000. De-escalation of the dosage from 20 to 10 mg/day was not associated with significant changes of DAS28 (1.99 ± 1.25 increased to 2.1 ±0.96 respectively, p=0.82). <h3>Conclusion:</h3> Escalation of dosage of TF in RA lead to improvement of the disease activity in non-complete responders, who achieved DAS 28 3.2-5.1, but not in patients with absence of any response (DAS28 before escalation 5.3-6.9). De-escalation of TF' dosage in patients with DAS28 &lt; 2.6 dose not lead to significant changes of RA's activity. <h3>References:</h3> [1] Fleischmann R, et al. Lancet. 2017 Jul 29;390(10093):457-468. doi: 10.1016/S0140-6736(17)31618-5. <h3>Acknowledgement:</h3> Pfizer is sponsor of register Technical support ASTON group <h3>Disclosure of Interests:</h3> Inna Gaydukova Grant/research support from: JSC BIOCAD, Speakers bureau: paiment from Pfizer, Novartis, Abbvie, Biocad, Selgene, MSD, Sanofy does not exceed 10 000 euros, V Mazurov Grant/research support from: JSC BIOCAD, Elizaveta Vasilenko: None declared, Evgeniy Zhilyaev: None declared, Vyacheslav Poncratov: None declared, Valentina Sorotskaya: None declared, Galina Lukina: None declared, Oxana Fomina: None declared, Aida Babaeva: None declared, N Lapkina: None declared, Anna Misiyuk: None declared, A Pavlova: None declared, Evgeny Nasonov: None declared