Artikel
Long-term efficacy and safety analysis of tofacitinib in the treatment of rheumatoid arthritis in a Western European subpopulation
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Autoren
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Jürgen Wollenhaupt
- Schön Klinik Hamburg Eilbek, Klinik für Rheumatologie und klinische Immunologie, Hamburg
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Jürgen Rech
- Universitätsklinikum Erlangen, Medizinische Klinik 3, Rheumatologie und Immunologie, Erlangen
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Christoph G. O. Baerwald
- Universitätsklinikum Leipzig, Klinik und Poliklinik für Gastroenterologie und Rheumatologie, Sektion Rheumatologie, Leipzig
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Ralph Lippe
- Pfizer Pharma GmbH, Berlin
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Friedrich Wolf
- Pfizer Pharma GmbH, Berlin
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Kenneth Kwok
- Pfizer Inc., New York, USA
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Tatjana Lukic
- Pfizer Inc., New York, USA
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Olaf Behmer
- Pfizer Pharma GmbH, Berlin
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Rieke H.-E. Alten
- Schlossparkklinik, Akademisches Lehrkrankenhaus der Charité - Universitätsmedizin Berlin, Innere Medizin II, Rheumatologie, klinische Immunologie und Osteologie, Berlin
| Veröffentlicht: | 29. August 2016 |
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Gliederung
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Background: Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). This analysis assessed the long-term efficacy and safety of tofacitinib within the Western European (WE) subpopulation of the global study programme.
Methods: Efficacy and safety data were from open-label long-term extension (LTE) studies of tofacitinib (NCT00413699 [database not locked at March 2015 data-cut] and NCT00661661 [completed at March 2015 data-cut]) in patients with RA who participated in randomised Phase 1/2/3 tofacitinib studies. Additional safety data were from an integrated safety summary of randomised Phase 1/2/3/LTE studies in RA patients. Safety endpoints included AEs, serious AEs (SAEs) and serious infection events (SIEs). Efficacy endpoints included DAS28-4(ESR), HAQ-DI and rates of ACR20/50/70. Patients who had received ≥1 dose of tofacitinib 5 or 10 mg twice daily were included in the pooled analyses.
Results: 425 of 4867 patients treated in LTE studies were from WE (193 from Germany). The mean (SD) age of WE patients was 55.7 years (12.0), 97% were white and 80% were female. The mean duration of RA was 8.9 years (range: 0.1 – 38.0 years). The total tofacitinib exposure for the WE population was ~1321 patient-years. In WE, 193 patients (45.4%) discontinued: AEs, 89 (20.9%); insufficient clinical response, 38 (8.9%). AEs occurred in 91.5% of patients, SAEs in 39.3% of patients and SIEs in 9.6% of patients. The most common AE classes (≥5% in any treatment group) were infections and infestations (59.5%) and musculoskeletal/connective tissue disorders (31.8%). The most common AEs were nasopharyngitis (26.8%), bronchitis (14.8%), urinary tract infection and back pain (14.1% each). Mean DAS28-4(ESR) was 6.05 at baseline, decreasing to 3.55 at Month 1 and 2.69 at Month 84. Mean HAQ-DI score was 1.45 at baseline, decreasing to 0.99 at Month 1 and 0.67 at Month 84. Mean rates of ACR20/50/70 were 66.3/42.3/22.6% at Month 1, increasing to 88.9/88.9/66.7% at Month 84.
Conclusion: Within the WE subpopulation of the large, global, tofacitinib RA development programme, tofacitinib demonstrated a consistent safety profile and sustained efficacy (over 84 months).
