Improvement of Fatigue in Patients with Ankylosing Spondylitis Receiving Tofacitinib: Analyses of a Phase 3 Randomized Controlled Trial
Abstract Introduction Fatigue is a key symptom in patients with ankylosing spondylitis (AS). The objective of this analysis was to estimate the median time to initial and stable improvement events in fatigue in patients with AS receiving tofacitinib. Methods This post hoc analysis used data from a p...
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Adis, Springer Healthcare
2024-12-01
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| Series: | Rheumatology and Therapy |
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| Online Access: | https://doi.org/10.1007/s40744-024-00727-5 |
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| author | Laure Gossec Jessica A. Walsh Raj Sengupta Andrew G. Bushmakin Joseph C. Cappelleri Arne Yndestad Oluwaseyi Dina David Cella |
| author_facet | Laure Gossec Jessica A. Walsh Raj Sengupta Andrew G. Bushmakin Joseph C. Cappelleri Arne Yndestad Oluwaseyi Dina David Cella |
| author_sort | Laure Gossec |
| collection | DOAJ |
| description | Abstract Introduction Fatigue is a key symptom in patients with ankylosing spondylitis (AS). The objective of this analysis was to estimate the median time to initial and stable improvement events in fatigue in patients with AS receiving tofacitinib. Methods This post hoc analysis used data from a phase 3 trial (NCT03502616) in patients with active AS receiving tofacitinib 5 mg twice daily or placebo. Time to improvement in fatigue was assessed using the Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-F) total score, experience domain score, and impact domain score. The rapidity of improvement was assessed by time-to-event analyses (nonparametric Kaplan–Meier models); initial improvement events (i.e., time to first week of FACIT-F improvement) and stable improvement events (i.e., time to first week of FACIT-F improvement, sustained to 16 weeks) were examined. Results Overall, 269 patients were assessed (mean disease duration: 14.2 [standard deviation (SD): 9.8] years; mean baseline FACIT-F total score: 27.2 [SD: 9.3]). Median times to initial and stable improvement events in FACIT-F total and domain scores were significantly shorter and occurred in more patients receiving tofacitinib than placebo. Median time to initial and stable improvement events of 6 points in FACIT-F total score were 8 and 12 weeks with tofacitinib, respectively (placebo: not reached); 70.0% versus 48.5% of patients receiving tofacitinib versus placebo, respectively, experienced initial improvements of 6 points in FACIT-F total score within 16 weeks. Conclusions Improvements in fatigue occurred more rapidly with tofacitinib than with placebo. These results may be useful for healthcare providers when discussing tofacitinib treatment expectations with patients. Trial Registration ClinicalTrials.gov: NCT03502616 (June 7, 2018). |
| format | Article |
| id | doaj-art-1ca96668486e4fef89ec14524ab7b7e3 |
| institution | Kabale University |
| issn | 2198-6576 2198-6584 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | Adis, Springer Healthcare |
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| series | Rheumatology and Therapy |
| spelling | doaj-art-1ca96668486e4fef89ec14524ab7b7e32025-01-26T12:52:08ZengAdis, Springer HealthcareRheumatology and Therapy2198-65762198-65842024-12-01121859810.1007/s40744-024-00727-5Improvement of Fatigue in Patients with Ankylosing Spondylitis Receiving Tofacitinib: Analyses of a Phase 3 Randomized Controlled TrialLaure Gossec0Jessica A. Walsh1Raj Sengupta2Andrew G. Bushmakin3Joseph C. Cappelleri4Arne Yndestad5Oluwaseyi Dina6David Cella7Sorbonne Université, INSERM, Institut Pierre Louis d’Epidémiologie et de Santé PubliqueDepartment of Veterans Affairs Medical Health Center, University of Utah Health and George E. WahlenRoyal National Hospital for Rheumatic DiseasesStatistical Research and Data Science Center, Pfizer IncStatistical Research and Data Science Center, Pfizer IncInflammation and Immunology, Pfizer IncInternal Medicine, Pfizer IncDepartment of Medical Social Sciences, Northwestern University Feinberg School of MedicineAbstract Introduction Fatigue is a key symptom in patients with ankylosing spondylitis (AS). The objective of this analysis was to estimate the median time to initial and stable improvement events in fatigue in patients with AS receiving tofacitinib. Methods This post hoc analysis used data from a phase 3 trial (NCT03502616) in patients with active AS receiving tofacitinib 5 mg twice daily or placebo. Time to improvement in fatigue was assessed using the Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-F) total score, experience domain score, and impact domain score. The rapidity of improvement was assessed by time-to-event analyses (nonparametric Kaplan–Meier models); initial improvement events (i.e., time to first week of FACIT-F improvement) and stable improvement events (i.e., time to first week of FACIT-F improvement, sustained to 16 weeks) were examined. Results Overall, 269 patients were assessed (mean disease duration: 14.2 [standard deviation (SD): 9.8] years; mean baseline FACIT-F total score: 27.2 [SD: 9.3]). Median times to initial and stable improvement events in FACIT-F total and domain scores were significantly shorter and occurred in more patients receiving tofacitinib than placebo. Median time to initial and stable improvement events of 6 points in FACIT-F total score were 8 and 12 weeks with tofacitinib, respectively (placebo: not reached); 70.0% versus 48.5% of patients receiving tofacitinib versus placebo, respectively, experienced initial improvements of 6 points in FACIT-F total score within 16 weeks. Conclusions Improvements in fatigue occurred more rapidly with tofacitinib than with placebo. These results may be useful for healthcare providers when discussing tofacitinib treatment expectations with patients. Trial Registration ClinicalTrials.gov: NCT03502616 (June 7, 2018).https://doi.org/10.1007/s40744-024-00727-5Ankylosing spondylitisFatigueTofacitinib |
| spellingShingle | Laure Gossec Jessica A. Walsh Raj Sengupta Andrew G. Bushmakin Joseph C. Cappelleri Arne Yndestad Oluwaseyi Dina David Cella Improvement of Fatigue in Patients with Ankylosing Spondylitis Receiving Tofacitinib: Analyses of a Phase 3 Randomized Controlled Trial Rheumatology and Therapy Ankylosing spondylitis Fatigue Tofacitinib |
| title | Improvement of Fatigue in Patients with Ankylosing Spondylitis Receiving Tofacitinib: Analyses of a Phase 3 Randomized Controlled Trial |
| title_full | Improvement of Fatigue in Patients with Ankylosing Spondylitis Receiving Tofacitinib: Analyses of a Phase 3 Randomized Controlled Trial |
| title_fullStr | Improvement of Fatigue in Patients with Ankylosing Spondylitis Receiving Tofacitinib: Analyses of a Phase 3 Randomized Controlled Trial |
| title_full_unstemmed | Improvement of Fatigue in Patients with Ankylosing Spondylitis Receiving Tofacitinib: Analyses of a Phase 3 Randomized Controlled Trial |
| title_short | Improvement of Fatigue in Patients with Ankylosing Spondylitis Receiving Tofacitinib: Analyses of a Phase 3 Randomized Controlled Trial |
| title_sort | improvement of fatigue in patients with ankylosing spondylitis receiving tofacitinib analyses of a phase 3 randomized controlled trial |
| topic | Ankylosing spondylitis Fatigue Tofacitinib |
| url | https://doi.org/10.1007/s40744-024-00727-5 |
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