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Abstract Number: 1880

Baricitinib 4 Mg and 2 Mg Once Daily Reduced Pain in Both Patients Who Were Opioid Users and Non-users in Active Rheumatoid Arthritis: A Post-hoc Analysis of Phase 3 Trials

Janet Pope1, Yvonne Lee 2, Jeffrey Curtis 3, Daojun Mo 4, Terence Rooney 4, Li Xie 4, Christina Dickson 4, Douglas Schlichting 4, Amanda Quebe 4, Anabela Cardoso 4, Lee Simon 5 and Peter Taylor 6, 1Western University, London, ON, Canada, 2Northwestern University Feinberg School of Medicine, Chicago, 3University of Alabama at Birmingham, Birmingham, AL, 4Eli Lilly and Company, Indianapolis, IN, 5SDG LLC, Cambridge, MA, 6University of Oxford, Oxford, United Kingdom

Meeting: 2019 ACR/ARP Annual Meeting

Keywords: Adalimumab, baricitinib, opioids, pain and rheumatoid arthritis (RA)

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Session Information

Date: Monday, November 11, 2019

Session Title: 4M115: Pain Mechanisms – Basic & Clinical Science (1878–1883)

Session Type: ACR Abstract Session

Session Time: 4:30PM-6:00PM

Background/Purpose: Opioid use in RA patients has increased over the past 2 decades in the US. Little is known about the combined effects of opioids and disease-modifying antirheumatic drugs (DMARDs) on pain in RA. To assess pain reduction in opioid users and non-users, we tested the effect of 1) 4 mg baricitinib (BARI), an oral JAK1/JAK2 inhibitor, vs. placebo (PBO) with data pooled from Phase 3 trials, RA-BEAM (NCT01710358, with RA patients with an inadequate response [IR] to MTX), RA-BUILD (NCT01721057, with those with IR to conventional DMARDs), and RA-BEACON (NCT01721044, with those with IR to ≥1 tumor necrosis factor inhibitors), 2) BARI 2 mg vs. PBO in RA-BEACON, and 3) subcutaneous 40 mg adalimumab (ADA) every other week vs. PBO in RA-BEAM.

Methods: Opioid users were patients who reported opioid use during the trials. The number of opioid users/the total number of randomized patients were: 171/891 BARI 4 mg and 153/892 PBO in the pooled analysis, 54/174 BARI 2 mg and 58/176 PBO in RA-BEACON, and 34/330 ADA and 50/488 PBO in RA-BEAM. Pain was measured by the Patient’s Assessment of Pain visual analog scale (VAS, 0-100 mm). Last observation before treatment discontinuation or rescue was carried forward through Week 24. An ANCOVA model assessed differences in pain reduction at each time point between BARI 4 mg and PBO (pooled), BARI 2 mg and PBO (RA-BEACON), and ADA and PBO (RA-BEAM) by opioid users and non-users. Baseline pain VAS, age, BMI, and trial were covariates in the model. Heterogeneity of treatment effect (active vs. PBO) was evaluated across opioid users and non-users by interaction test. Analyses were not adjusted for multiplicity.

Results: BARI 4 mg had greater pain reduction vs. PBO in opioid users and non-users (P< 0.05) at all time points (Weeks 1, 2, 4, 8, 12, 14, 16, 20 and 24). Pain reduction in BARI 4 mg vs. PBO was similar between opioid users and non-users at all time points (interaction P >0.1 at all time points). At Week 24, the difference in pain VAS reduction between BARI 4 mg vs. PBO was -13.4 mm (95% CI: -19.0, -7.8) in opioid users and -14.3 mm (-16.7, -11.9) in non-users, interaction P=0.8. In RA-BEACON, BARI 2 mg had greater pain reduction vs. PBO in both opioid users and non-users (P< 0.05) starting at Week 12. Pain reduction with BARI 2 mg vs. PBO was similar between opioid users and non-users at all time points (interaction P >0.1 at all time points). At Week 24, the difference in pain VAS reduction between BARI 2 mg vs. PBO was -10.7 mm (-19.5, -1.9) in opioid users and -8.3 mm (-15.0, -1.6) in non-users, interaction P=0.8. In RA-BEAM, a significant difference in pain reduction was not observed for ADA vs. PBO in the opioid users; whereas, for non-users, a difference in pain reduction was observed for ADA vs. PBO at all time points (P< 0.05). At Week 24, the difference in pain VAS reduction between ADA vs. PBO was -4.9 mm (95% CI:-16.4, 6.6) in opioid users and -12.2 mm (-15.6, -8.9) in non-users, interaction P=0.2.

Conclusion: Pain reduction with BARI 4 mg was similar between opioid users and non-users and was observed at all time points. Pain reduction with BARI 2 mg vs. PBO was similar between opioid users and non-users from Week 12.  In contrast, ADA did not result in pain reduction compared to PBO in opioid users.


Disclosure: J. Pope, AbbVie, 5, Abbvie, 5, Actelion, 5, Actellion, 5, Amgen, 2, 5, AstraZeneca, 2, Astra-Zeneca, 2, Bayer, 2, 5, BMS, 2, 5, Eicos Sciences, 5, Eli Lilly & Company, 5, Eli Lilly and Company, 5, EMERALD, 5, Emerald, 5, Genzyme, 5, Janssen, 5, Lilly, 5, Merck, 2, 5, Novartis, 5, Pfizer, 2, 5, Roche, 2, 5, Sandoz, 5, Sanofi, 5, Seattle Genetics, 2, UCB, 2, 5, 8; Y. Lee, Cigna Corp, 1, Eli Lilly, 2, 5, Eli Lilly and Company, 2, Express Scripts, 4, Pfizer, 2; J. Curtis, AbbVie, 2, 5, Amgen, 2, 5, BMS, 2, 5, Corrona, 2, 5, Eli Lilly & Company, 2, 5, Janssen, 2, 5, Myriad, 2, 5, Pfizer, 2, 5, Regeneron, 2, 5, Roche, 2, 5, UCB, 2, 5; D. Mo, Eli Lilly and Company, 1, 3; T. Rooney, Eli Lilly and Company, 1, 3; L. Xie, Eli Lilly and Company, 1, 3; C. Dickson, Eli Lilly and Company, 1, 3; D. Schlichting, Eli Lilly and Company, 1, 3; A. Quebe, Eli Lilly & Company, 3, 4, Eli Lilly and Company, 1, 3; A. Cardoso, Eli Lilly and Company, 1, 3; L. Simon, Eli Lilly and Company, 5, AstraZeneca, 5, NuvoResearch, 5, Roche, 5, Pfizer, 5, Bayer, 5, Regeneron, 5, Gilead, 5; P. Taylor, AbbVie, 5, Abbvie, 5, Biogen, 5, Celgene, 2, 5, Eli Lilly and Company, 2, 5, Fresenius, 5, Fresenius SE & Co, 5, Fresnius, 5, Galapagos, 2, 5, Gilead, 5, GlaxoSmithKline, 5, Janssen, 2, 5, Lilly, 2, 5, Nordic Pharma, 5, NORDIC Pharma, 5, Pfizer, 5, Pfizer Inc, 5, Roche, 5, Sanofi, 5, UCB, 5.

To cite this abstract in AMA style:

Pope J, Lee Y, Curtis J, Mo D, Rooney T, Xie L, Dickson C, Schlichting D, Quebe A, Cardoso A, Simon L, Taylor P. Baricitinib 4 Mg and 2 Mg Once Daily Reduced Pain in Both Patients Who Were Opioid Users and Non-users in Active Rheumatoid Arthritis: A Post-hoc Analysis of Phase 3 Trials [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/baricitinib-4-mg-and-2-mg-once-daily-reduced-pain-in-both-patients-who-were-opioid-users-and-non-users-in-active-rheumatoid-arthritis-a-post-hoc-analysis-of-phase-3-trials/. Accessed January 18, 2021.
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