Abstract
Objective: Pain reduction with baricitinib was assessed in patients with rheumatoid arthritis (RA) who either used opioids or did not use opioids during three randomized, double-blind phase 3 trials. Methods: Analysis populations were as follows: i) baricitinib 4 mg once daily versus placebo groups integrated from RA-BEAM (NCT01710358) for patients with inadequate response (IR) to methotrexate, RA-BUILD (NCT01721057) with IR to conventional disease-modifying antirheumatic drugs, and RA-BEACON (NCT01721044) with IR to at least one tumor necrosis factor inhibitors; ii) baricitinib 2 mg versus placebo from RA-BUILD and RA-BEACON; and iii) adalimumab 40 mg every other week versus placebo from RA-BEAM. Pain was measured by the Patient Assessment of Pain Visual Analog Scale. Analysis of covariance modeling assessed differences in pain reduction between treatments at each time point through Week 24, with an interaction term to test heterogeneous treatment effects across opioid users and nonusers. Results: Baricitinib 4 mg had greater pain reduction versus placebo in opioid users and nonusers (P < 0.05) at all time points starting from Week 1; the pain reduction was similar between opioid users and nonusers. Baricitinib 2 mg had greater pain reduction versus placebo in opioid users and nonusers starting at Week 4. A significant difference in pain reduction was not observed for adalimumab versus placebo in the opioid users but was observed in nonusers at all time points. Conclusion: Pain reduction was observed and was similar between opioid users and nonusers with baricitinib 2 mg and 4 mg but not adalimumab in this post hoc analysis.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 254-258 |
| Number of pages | 5 |
| Journal | ACR open rheumatology |
| Volume | 4 |
| Issue number | 3 |
| DOIs | |
| State | Published - Mar 2022 |
Funding
The authors would like to thank Molly E. Tomlin, MS, MEd, of Eli Lilly and Company for her assistance with manuscript preparation and process support and Amanda Quebe for her review and feedback on the manuscript. Lilly provides access to relevant anonymized patient-level data from studies on approved medicines and indications as defined by the sponsor-specific information on www.clinicalstudydatarequest.com. For details on submitting a request, see the instructions provided at www.clinicalstudydatarequest.com. Dr. Taylor would like to thank the National Institute of Health Research for their funding of The National Institute for Health Research Biomedical Research Centre in Musculoskeletal Disease at Oxford University Hospitals National Health System Trust and the University of Oxford.
ASJC Scopus subject areas
- Rheumatology