AB0388 FRENCH REAL LIFE SAFETY DATA ON THE USE OF TOFACITINIB IN PATIENTS WITH RHEUMATOID ARTHRITIS: OBSERVATIONAL STUDY, DeFacTo

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Titel: AB0388 FRENCH REAL LIFE SAFETY DATA ON THE USE OF TOFACITINIB IN PATIENTS WITH RHEUMATOID ARTHRITIS: OBSERVATIONAL STUDY, DeFacTo
Beteiligte: Gaujoux-Viala, C.; Basch, A.; Lassoued, S.; Coury-Lucas, F.; Kessouri, M.; Mammar, N.; Brault, Y.; Lequerre, T.; Salliot, C.
Erschienen: BMJ, 2022
Erschienen in: Annals of the Rheumatic Diseases, 81 (2022) Suppl 1, Seite 1322.1-1322
Sprache: Englisch
DOI: 10.1136/annrheumdis-2022-eular.601
ISSN: 0003-4967; 1468-2060
Schlagwörter: General Biochemistry, Genetics and Molecular Biology ; Immunology ; Immunology and Allergy ; Rheumatology
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Beschreibung: <jats:sec><jats:title>Background</jats:title><jats:p>Tofacitinib, an oral Janus Kinase inhibitor, is indicated in the treatment of adult patients (pts) with active, moderate to severe rheumatoid arthritis (RA).</jats:p></jats:sec><jats:sec><jats:title>Objectives</jats:title><jats:p>The objective of this work is to describe the tofacitinib’s safety profile in the DeFacTo study (French prospective observational study).</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>The safety profile of tofacitinib was assessed on the basis of interim data from a descriptive analysis of pts having taken at least one dose of tofacitinib in the context of the DeFacTo study.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Of the 313 pts enrolled in the study, 301 had received tofacitinib and were included in the safety analysis. Of these, 276 fulfilled the eligibility criteria and included 219 who had ≥ 1 year follow-up and a mean exposure period of 368 ± 197.1 days. As of 15 March 2021, 122 patients are continuing to take tofacitinib therapy (76 missing prescription data). On inclusion, 77.9% of the 276 pts were females of mean (± SD) age 59.7 ± 11.7 years and a median disease duration of 9.1 years [Q1;Q3: 4.1; 19.2]. A history of cardiovascular disease was found in 12.5% of cases, (4.4% myocardial infraction, 5.5% stroke/transient ischemic attack, 1.5% heart failure and 1.5% peripheral arterial occlusive disease); 5.5% had a history of cancer, 17.5% a prior infection and 46% were smokers/former smokers. Tofacitinib was prescribed in combination with a csDMARD in 58.3% of pts and with corticosteroids in 54.3% of cases. At the cut-off date of 15 March 2021, of the 301 patients, adverse effects (AE) had been reported in 44.9% of cases of which 10.6% were considered serious (SAE). Infections were detected in 18.6% of pts (Table 1).</jats:p><jats:table-wrap id="T1" position="float" orientation="portrait"><jats:label>Table 1.</jats:label><jats:caption><jats:p><jats:bold>Real life safety data for tofacitinib according to age</jats:bold></jats:p></jats:caption><jats:table><jats:thead><jats:tr><jats:th align="left" rowspan="1" colspan="1">N, (%)</jats:th><jats:th align="left" rowspan="1" colspan="1">< 65 years (n=190)</jats:th><jats:th align="left" rowspan="1" colspan="1">≥ 65 years (n=110)</jats:th><jats:th align="left" rowspan="1" colspan="1">Total (n=301*)</jats:th></jats:tr></jats:thead><jats:tbody><jats:tr><jats:td align="left" rowspan="1" colspan="1">Adverse effect</jats:td><jats:td align="left" rowspan="1" colspan="1">80 (42.1)</jats:td><jats:td align="left" rowspan="1" colspan="1">55 (50.0)</jats:td><jats:td align="left" rowspan="1" colspan="1">135 (44.9)</jats:td></jats:tr><jats:tr><jats:td align="left" rowspan="1" colspan="1">Serious adverse effect</jats:td><jats:td align="left" rowspan="1" colspan="1">16 (8.4)</jats:td><jats:td align="left" rowspan="1" colspan="1">16 (14.5)</jats:td><jats:td align="left" rowspan="1" colspan="1">32 (10.6)</jats:td></jats:tr><jats:tr><jats:td align="left" rowspan="1" colspan="1">Infection</jats:td><jats:td align="left" rowspan="1" colspan="1">33 (17.4)</jats:td><jats:td align="left" rowspan="1" colspan="1">23 (20.9)</jats:td><jats:td align="left" rowspan="1" colspan="1">56 (18.6)</jats:td></jats:tr><jats:tr><jats:td align="left" rowspan="1" colspan="1">Severe infection</jats:td><jats:td align="left" rowspan="1" colspan="1">3 (1.6)</jats:td><jats:td align="left" rowspan="1" colspan="1">4 (3.6)</jats:td><jats:td align="left" rowspan="1" colspan="1">7 (2.3)</jats:td></jats:tr><jats:tr><jats:td colspan="4" rowspan="1">AE of interest (number of events)</jats:td></jats:tr><jats:tr><jats:td colspan="4" rowspan="1"> Infection</jats:td></jats:tr><jats:tr><jats:td align="left" rowspan="1" colspan="1"> Herpes zoster</jats:td><jats:td align="left" rowspan="1" colspan="1">5</jats:td><jats:td align="left" rowspan="1" colspan="1">5</jats:td><jats:td align="left" rowspan="1" colspan="1">10</jats:td></jats:tr><jats:tr><jats:td align="left" rowspan="1" colspan="1"> Severe infection</jats:td><jats:td align="left" rowspan="1" colspan="1" /><jats:td align="left" rowspan="1" colspan="1" /><jats:td align="left" rowspan="1" colspan="1" /></jats:tr><jats:tr><jats:td align="left" rowspan="1" colspan="1"> Herpes zoster</jats:td><jats:td align="left" rowspan="1" colspan="1">1</jats:td><jats:td align="left" rowspan="1" colspan="1">0</jats:td><jats:td align="left" rowspan="1" colspan="1">1</jats:td></jats:tr><jats:tr><jats:td align="left" rowspan="1" colspan="1"> Tuberculosis</jats:td><jats:td align="left" rowspan="1" colspan="1">0</jats:td><jats:td align="left" rowspan="1" colspan="1">2</jats:td><jats:td align="left" rowspan="1" colspan="1">2</jats:td></jats:tr><jats:tr><jats:td align="left" rowspan="1" colspan="1"> Cancer</jats:td><jats:td align="left" rowspan="1" colspan="1" /><jats:td align="left" rowspan="1" colspan="1" /><jats:td align="left" rowspan="1" colspan="1" /></jats:tr><jats:tr><jats:td align="left" rowspan="1" colspan="1"> Small-cell carcinoma</jats:td><jats:td align="left" rowspan="1" colspan="1">0</jats:td><jats:td align="left" rowspan="1" colspan="1">1</jats:td><jats:td align="left" rowspan="1" colspan="1">1</jats:td></jats:tr><jats:tr><jats:td align="left" rowspan="1" colspan="1"> MACE</jats:td><jats:td align="left" rowspan="1" colspan="1" /><jats:td align="left" rowspan="1" colspan="1" /><jats:td align="left" rowspan="1" colspan="1" /></jats:tr><jats:tr><jats:td align="left" rowspan="1" colspan="1"> Stroke</jats:td><jats:td align="left" rowspan="1" colspan="1">1</jats:td><jats:td align="left" rowspan="1" colspan="1">0</jats:td><jats:td align="left" rowspan="1" colspan="1">1</jats:td></jats:tr><jats:tr><jats:td align="left" rowspan="1" colspan="1"> Thromboembolic events</jats:td><jats:td align="left" rowspan="1" colspan="1" /><jats:td align="left" rowspan="1" colspan="1" /><jats:td align="left" rowspan="1" colspan="1" /></jats:tr><jats:tr><jats:td align="left" rowspan="1" colspan="1"> Venous thrombosis</jats:td><jats:td align="left" rowspan="1" colspan="1">0</jats:td><jats:td align="left" rowspan="1" colspan="1">1</jats:td><jats:td align="left" rowspan="1" colspan="1">1</jats:td></jats:tr><jats:tr><jats:td align="left" rowspan="1" colspan="1">Death</jats:td><jats:td align="left" rowspan="1" colspan="1">0</jats:td><jats:td align="left" rowspan="1" colspan="1">0</jats:td><jats:td align="left" rowspan="1" colspan="1">0</jats:td></jats:tr></jats:tbody></jats:table><jats:table-wrap-foot><jats:fn><jats:p>*1 patient for whom age is unknown but is counted in the total.</jats:p></jats:fn></jats:table-wrap-foot></jats:table-wrap></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>These purely descriptive interim results reveal a safety profile for tofacitinib in patients with RA, similar to that previously reported in clinical and observational studies. <jats:sup>(1-2)</jats:sup></jats:p></jats:sec><jats:sec><jats:title>References</jats:title><jats:p>[1]Wollenhaupt <jats:italic>et al</jats:italic>. Arthritis Research & Therapy (2019) 21:89 <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="https://doi.org/10.1186/s13075-019-1866-2">https://doi.org/10.1186/s13075-019-1866-2</jats:ext-link></jats:p><jats:p>[2]Kremer <jats:italic>et al</jats:italic>. ACR Open Rheumatology 2021. DOI 10.1002/acr2.11232</jats:p></jats:sec><jats:sec><jats:title>Acknowledgements</jats:title><jats:p>To all investigators involved in this study, and all patients included in this study</jats:p></jats:sec><jats:sec><jats:title>Disclosure of Interests</jats:title><jats:p>Cécile Gaujoux-Viala Speakers bureau: AbbVie; Amgen; Bristol-Myers Squibb; Celgene; Eli Lilly; Galapagos; Gilead Sciences, Inc.; Janssen; Medac; Merck-Serono; Mylan; Nordic Pharma; Novartis; Pfizer; Roche; Sandoz; Sanofi; and UCB, Consultant of: AbbVie; Amgen; Boeringhe; Bristol-Myers Squibb; Celgene; Eli Lilly; Galapagos; Gilead Sciences, Inc.; Janssen; Medac; Merck-Serono; Mylan; Nordic Pharma; Novartis; Pfizer; Roche; Sandoz; Sanofi; and UCB, Andre BASCH Speakers bureau: Janssen, Novartis, Amgen, BMS, Abbvie, Lilly, Pfizer, MSD, UCB, Consultant of: Janssen, Novartis, Amgen, BMS, Abbvie, Lilly, Pfizer, MSD, UCB,, Slim Lassoued: None declared, Fabienne COURY-LUCAS Consultant of: AbbVie, Bristol-Myers Squibb, Janssen, Lilly, MSD, Novartis and Pfizer, Grant/research support from: AbbVie, Biogen, Roche Chugai, Pfizer, and UCB,, Meriem Kessouri Shareholder of: Pfizer, Employee of: Pfizer, Nadir Mammar Shareholder of: Pfizer, Employee of: Pfizer, Yves Brault Shareholder of: Pfizer, Employee of: Pfizer, Thierry Lequerre Consultant of: Abbvie, BMS, Boeringher, Lilly, Medac, MSD, Nordic Pharma, Novartis, Pfizer, Roche – Chugai, Sanofi, UCB,, Carine Salliot Consultant of: Biogen, Lilly, Novartis, Roche Chugai, Pfizer</jats:p></jats:sec>

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