Abstract | OBJECTIVE: METHODS: Data were collected from patients in seven tofacitinib studies: six phase III (four RA, two PsA) and one phase II study (AS), and grouped into five analysis populations based on rheumatic disease diagnosis and category of prior inadequate response (IR) to treatment: conventional synthetic disease-modifying antirheumatic drugs-IR (RA and PsA), tumour necrosis factor inhibitors-IR (RA and PsA), or non-steroidal anti-inflammatory drugs-IR (AS). Only patients who received tofacitinib 5 or 10 mg twice daily or placebo were included. Pain assessments included: Patient's Assessment of Arthritis Pain, Short-Form Health Survey 36v2 Question (Q)7 and Bodily Pain domain, Ankylosing Spondylitis Quality of Life Q9 and Q14, EuroQol Five Dimensions Pain/Discomfort dimension and Bath Ankylosing Spondylitis Disease Activity Index Q2 and Q3. Data were reported to month 6 (placebo to month 3) in the RA and PsA populations, and week 12 ( tofacitinib and placebo) in the AS population. RESULTS: Overall, 3330 patients were included in this analysis. In the RA and PsA populations, pain improvements in tofacitinib-treated patients compared with placebo were observed at the earliest time point assessed and at month 3 (maintained to month 6). In the AS population, pain improvements compared with placebo were observed at week 12. CONCLUSION:
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Authors | Alexis Ogdie, Kurt de Vlam, Iain B McInnes, Philip J Mease, Philip Baer, Tatjana Lukic, David Gruben, Kenneth Kwok, Cunshan Wang, Ming-Ann Hsu, Anna Maniccia |
Journal | RMD open
(RMD Open)
Vol. 6
Issue 1
(02 2020)
ISSN: 2056-5933 [Electronic] England |
PMID | 32396519
(Publication Type: Clinical Trial, Phase II, Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. |
Chemical References |
- Anti-Inflammatory Agents, Non-Steroidal
- Antirheumatic Agents
- Piperidines
- Placebos
- Protein Kinase Inhibitors
- Pyrimidines
- Tumor Necrosis Factor Inhibitors
- tofacitinib
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Topics |
- Adult
- Anti-Inflammatory Agents, Non-Steroidal
(therapeutic use)
- Antirheumatic Agents
(therapeutic use)
- Arthritis, Psoriatic
(drug therapy)
- Arthritis, Rheumatoid
(drug therapy)
- Case-Control Studies
- Female
- Humans
- Male
- Middle Aged
- Pain
(drug therapy, etiology, prevention & control)
- Pain Management
- Pain Measurement
(methods)
- Patient Reported Outcome Measures
- Piperidines
(administration & dosage, therapeutic use)
- Placebos
(administration & dosage)
- Protein Kinase Inhibitors
(administration & dosage, therapeutic use)
- Pyrimidines
(administration & dosage, therapeutic use)
- Quality of Life
- Spondylitis, Ankylosing
(drug therapy)
- Treatment Outcome
- Tumor Necrosis Factor Inhibitors
(therapeutic use)
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