Use of tofacitinib in real clinical practice to treat patients with rheumatoid arthritis resistant to synthetic and biological disease-modifying antirheumatic drugs: Results of a multicenter observational study
Tofacitinib (TOFA), a member of a new class of targeted synthetic disease-modifying antirheumatic drugs (DMARDs), is a promising medication for the treatment of rheumatoid arthritis (RA) and other immunoinflammatory diseases. The paper describes the Russian experi-ence with TOFA used to treat severe...
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IMA-PRESS LLC
2016-09-01
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| Series: | Современная ревматология |
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| author | D. E. Karateev D. E. Abdulganieva A. R. Babaeva A. A. Baranov L. P. Evstigneeva O. N. Ivanova G. V. Lukina E. L. Luchikhina V. I. Mazurov A. S. Misiyuk O. V. Semagina A. E. Sizikov V. N. Sorotskaya |
| author_facet | D. E. Karateev D. E. Abdulganieva A. R. Babaeva A. A. Baranov L. P. Evstigneeva O. N. Ivanova G. V. Lukina E. L. Luchikhina V. I. Mazurov A. S. Misiyuk O. V. Semagina A. E. Sizikov V. N. Sorotskaya |
| author_sort | D. E. Karateev |
| collection | DOAJ |
| description | Tofacitinib (TOFA), a member of a new class of targeted synthetic disease-modifying antirheumatic drugs (DMARDs), is a promising medication for the treatment of rheumatoid arthritis (RA) and other immunoinflammatory diseases. The paper describes the Russian experi-ence with TOFA used to treat severe RA.Patients and methods. 101 RA patients (18 men and 83 women; mean age, 51.03±11.28 years; mean disease duration, 105.4±81.43 months) who were positive for rheumatoid factor (89.1%) and anti-cyclic citrullinated peptide antibodies (74.7%) and resistant to therapy with synthetic DMARDs (sDMARDs) (80.2%) and biological agents (19.8%) were given TOFA at a dose of 5 mg twice daily, which could be doubled if necessary. TOFA was used alone (n=9) or in combination with methotrexate (MT) (n=75) or other sDMARDs (n=17). The achievement of low disease activity (LDA) and clinical remission at 3 and 6 months of treatment by DAS28-ESR SDAI, and CDAI scores, and the indices of safety and tolerability were assessed.Results. A total of 93 (92.1%) of the 101 patients completed a 24-week period of the investigation. 8 (7.9%) patients prematurely discontinued TOFA after an average of 2.75±0.71 months. At the end of the study, the patients achieved the primary endpoint (LDA including remission) in terms of DAS28-ESR ≤3.2 (34.7%), SDAI ≤11 (47.5%), and CDAI ≤10 (48.5%) and the secondary endpoints (clinical remission) in terms of DAS28-ESR ≤2.6 (17.8%), SDAI ≤3.3 (8.9%), and CDAI ≤2.8 (6.9%). When TOFA was combined with MT, the discontinuation rate for the former was significantly lower (2.7%) than when TOFA was used in combination with other sDMARDs (29.4%) or alone (11.1%; p<0.01). At 3 and 6 months of follow-up, LDA was achieved more frequently when TOFA was combined with MT than when other treatment regimens were used. Fatal outcomes and serious adverse events (AEs), as AEs previously undescribed in the literature, were not seen during a follow-up within the framework of the clinical trial. Only 2 patients discontinued TOFA because of AEs.Conclusion. The use of TOFA in RA is effective in achieving LDA in patients unresponsive to sDMARDs and biological DMARDs. The prescription of the drug makes it possible to monitor the activity of the inflammatory process and, with its sufficient safety and good tolerability, to achieve LDA in half of the patients, including those with multidrug resistance. |
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| issn | 1996-7012 2310-158X |
| language | Russian |
| last_indexed | 2025-03-14T08:20:04Z |
| publishDate | 2016-09-01 |
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| series | Современная ревматология |
| spelling | doaj.art-59fa1f3746ae4a15b40752fe3b17240e2025-03-02T13:10:59ZrusIMA-PRESS LLCСовременная ревматология1996-70122310-158X2016-09-01103526110.14412/1996-7012-2016-3-52-611989Use of tofacitinib in real clinical practice to treat patients with rheumatoid arthritis resistant to synthetic and biological disease-modifying antirheumatic drugs: Results of a multicenter observational studyD. E. Karateev0D. E. Abdulganieva1A. R. Babaeva2A. A. Baranov3L. P. Evstigneeva4O. N. Ivanova5G. V. Lukina6E. L. Luchikhina7V. I. Mazurov8A. S. Misiyuk9O. V. Semagina10A. E. Sizikov11V. N. Sorotskaya12V.A. Nasonova Research Institute of Rheumatology, Moscow, Russia 34A, Kashirskoe Shosse, Moscow 115522Republican Clinical Hospital, Ministry of Health of the Republic of Tatarstan, Kazan, Russia 138, Orenburgsky Road, Kazan, Republic of Tatarstan 420064City Clinical Hospital Four, Volgograd, Russia 40, Opolchenskaya St., Volgograd 400065Yaroslavl State Medical University, Ministry of Health of Russia, Yaroslavl, Russia 5, Revolyutsionnaya St., Yaroslavl 150000Sverdlovsk Regional Clinical Hospital One, Yekaterinburg, Russia 185, Volgogradskaya St., Yekaterinburg 620102Voronezh Regional Clinical Hospital One, Voronezh, Russia 151, Moskovsky Prospect, Voronezh 394066V.A. Nasonova Research Institute of Rheumatology, Moscow, Russia 34A, Kashirskoe Shosse, Moscow 115522 Moscow Clinical Research and Practical Center, Moscow Healthcare Department, Moscow, Russia 86, Shosse Entuziastov, Moscow 111123V.A. Nasonova Research Institute of Rheumatology, Moscow, Russia 34A, Kashirskoe Shosse, Moscow 115522I.I. Mechnikov North-Western State Medical University, Ministry of Health of Russia, Saint Petersburg, Russia 41, Kirochnaya St., Saint Petersburg 191015V.A. Nasonova Research Institute of Rheumatology, Moscow, Russia 34A, Kashirskoe Shosse, Moscow 115522M.I. Kalinin Samara Regional Hospital, Samara, Russia 159, Tashkentskaya St., Samara 443095Research Institute of Fundamental and Clinical Immunology, Siberian Branch, Russian Academy of Sciences, Novosibirsk, Russia 2/1, Zalessky St., Novosibirsk 630047Tula Regional Clinical Hospital, Tula, Russia 1a, Yablochkov St., Tula 300053Tofacitinib (TOFA), a member of a new class of targeted synthetic disease-modifying antirheumatic drugs (DMARDs), is a promising medication for the treatment of rheumatoid arthritis (RA) and other immunoinflammatory diseases. The paper describes the Russian experi-ence with TOFA used to treat severe RA.Patients and methods. 101 RA patients (18 men and 83 women; mean age, 51.03±11.28 years; mean disease duration, 105.4±81.43 months) who were positive for rheumatoid factor (89.1%) and anti-cyclic citrullinated peptide antibodies (74.7%) and resistant to therapy with synthetic DMARDs (sDMARDs) (80.2%) and biological agents (19.8%) were given TOFA at a dose of 5 mg twice daily, which could be doubled if necessary. TOFA was used alone (n=9) or in combination with methotrexate (MT) (n=75) or other sDMARDs (n=17). The achievement of low disease activity (LDA) and clinical remission at 3 and 6 months of treatment by DAS28-ESR SDAI, and CDAI scores, and the indices of safety and tolerability were assessed.Results. A total of 93 (92.1%) of the 101 patients completed a 24-week period of the investigation. 8 (7.9%) patients prematurely discontinued TOFA after an average of 2.75±0.71 months. At the end of the study, the patients achieved the primary endpoint (LDA including remission) in terms of DAS28-ESR ≤3.2 (34.7%), SDAI ≤11 (47.5%), and CDAI ≤10 (48.5%) and the secondary endpoints (clinical remission) in terms of DAS28-ESR ≤2.6 (17.8%), SDAI ≤3.3 (8.9%), and CDAI ≤2.8 (6.9%). When TOFA was combined with MT, the discontinuation rate for the former was significantly lower (2.7%) than when TOFA was used in combination with other sDMARDs (29.4%) or alone (11.1%; p<0.01). At 3 and 6 months of follow-up, LDA was achieved more frequently when TOFA was combined with MT than when other treatment regimens were used. Fatal outcomes and serious adverse events (AEs), as AEs previously undescribed in the literature, were not seen during a follow-up within the framework of the clinical trial. Only 2 patients discontinued TOFA because of AEs.Conclusion. The use of TOFA in RA is effective in achieving LDA in patients unresponsive to sDMARDs and biological DMARDs. The prescription of the drug makes it possible to monitor the activity of the inflammatory process and, with its sufficient safety and good tolerability, to achieve LDA in half of the patients, including those with multidrug resistance.https://mrj.ima-press.net/mrj/article/view/702rheumatoid resistancetherapy resistancedisease-modifying antirheumatic drugstofacitinib |
| spellingShingle | D. E. Karateev D. E. Abdulganieva A. R. Babaeva A. A. Baranov L. P. Evstigneeva O. N. Ivanova G. V. Lukina E. L. Luchikhina V. I. Mazurov A. S. Misiyuk O. V. Semagina A. E. Sizikov V. N. Sorotskaya Use of tofacitinib in real clinical practice to treat patients with rheumatoid arthritis resistant to synthetic and biological disease-modifying antirheumatic drugs: Results of a multicenter observational study Современная ревматология rheumatoid resistance therapy resistance disease-modifying antirheumatic drugs tofacitinib |
| title | Use of tofacitinib in real clinical practice to treat patients with rheumatoid arthritis resistant to synthetic and biological disease-modifying antirheumatic drugs: Results of a multicenter observational study |
| title_full | Use of tofacitinib in real clinical practice to treat patients with rheumatoid arthritis resistant to synthetic and biological disease-modifying antirheumatic drugs: Results of a multicenter observational study |
| title_fullStr | Use of tofacitinib in real clinical practice to treat patients with rheumatoid arthritis resistant to synthetic and biological disease-modifying antirheumatic drugs: Results of a multicenter observational study |
| title_full_unstemmed | Use of tofacitinib in real clinical practice to treat patients with rheumatoid arthritis resistant to synthetic and biological disease-modifying antirheumatic drugs: Results of a multicenter observational study |
| title_short | Use of tofacitinib in real clinical practice to treat patients with rheumatoid arthritis resistant to synthetic and biological disease-modifying antirheumatic drugs: Results of a multicenter observational study |
| title_sort | use of tofacitinib in real clinical practice to treat patients with rheumatoid arthritis resistant to synthetic and biological disease modifying antirheumatic drugs results of a multicenter observational study |
| topic | rheumatoid resistance therapy resistance disease-modifying antirheumatic drugs tofacitinib |
| url | https://mrj.ima-press.net/mrj/article/view/702 |
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