Speed of Onset of Effect on Patient-Reported Outcomes Assessed through Daily Electronic Patient Diaries in the Baricitinib Phase 3 RA Clinical Program

Peter C. Taylor¹, Grace C. Wright², Carol L. Gaich³, Amy M. DeLozier³, Stephanie de Bono³, Douglas E. Schlichting³, Terence Rooney³, Jiajun Liu³, Scott D. Beattie⁴ and Maxime Dougados⁵, ¹NDORMS, University of Oxford, Oxford, United Kingdom, ²NYU Langone Medical Center, New York, NM, ³Eli Lilly and Company, Indianapolis, IN, ⁴Lilly Corporate Center, Eli Lilly and Company, Indianapolis, IN, ⁵Dept of Rheumatology, Cochin Hospital, Paris, France

Meeting: 2016 ACR/ARHP Annual Meeting

Date of first publication: September 28, 2016

Keywords: patient outcomes, rheumatic disease and rheumatoid arthritis (RA), Rheumatology

Session Information

Date: Monday, November 14, 2016

Title: Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy - Poster II

Session Type: ACR Poster Session B

Session Time: 9:00AM-11:00AM

Background/Purpose: Baricitinib (bari), an oral Janus kinase (JAK) 1/JAK2 selective inhibitor, has demonstrated clinical efficacy with a satisfactory safety profile when administered once daily in 4 completed Phase 3 studies in patients with RA^1,2,3,4. In 2 studies, RA-BEAM (52-week study in patients with inadequate response (IR) to MTX) and RA-BUILD (24-week study in patients with IR to conventional synthetic [cs] DMARDs), patients recorded their worst joint pain, duration and severity of morning joint stiffness (MJS), and worst tiredness each day for 12 weeks using electronic diaries. In previous analyses based on weekly averages of daily scores³, bari produced significant improvements in patient-reported outcomes (PROs) compared to placebo (pbo) as early as Week 1 and compared to adalimumab (ada) as early as Weeks 2‑4. The aim of these analyses was to explore the kinetics of response using daily diary scores without weekly averaging.

Methods: PRO data were analyzed by study day after randomization (Day 1) – Day 28 for all treated patients. Mixed models for repeated measures analysis were applied (with MJS duration by nonparametric methods).

Results: Consistent with the original weekly-averaged data³, daily diary scores showed significant improvement in patients receiving bari compared to pbo and ada. Improvements relative to pbo were apparent as early as the 3^rd day of treatment for MJS severity, worst tiredness, and worst joint pain, and by Day 5 for MJS duration (Figure and Table). Improvements relative to ada were apparent as early as Day 19 for MJS severity, Day 21 for worst tiredness, and Day 17 for worst joint pain. The greatest rapidity and magnitude of benefit was seen with the bari 4-mg daily dose.

Conclusion: In this post hoc analysis from Phase 3 studies of patients with RA with inadequate response to MTX or other csDMARDs, treatment with bari produced rapid improvements in PROs compared to pbo and ada, with significant differences appearing within the initial days of treatment. References: ¹Dougados et al. Ann Rheum Dis 2015;74(S2):79;²Fleischmann et al. Arthritis Rheumatol 2015;67(S10):1360-1361; ³Taylor et al. presented at ACR 2015; ⁴Genovese et al. N Engl J Med 2016;374(13):1243-1252.

Disclosure: P. C. Taylor, UCB, Janssen, GSK, Abide therapeutics, 2,Eli Lilly and Company, Pfizer, Galapagos, Abbvie, Janssen, 5; G. C. Wright, Abbvie, Amgen, BMS, Crescendo, Genentech, Janssen, Eli Lilly and Company, Medac, Pfizer, Mallinckrodt, UCB, 5,Abbvie, Amgen, BMS, Crescendo, Genentech, Novartis, Mallinckrodt, UCB, 8,Assn of Women in Rheumatology, 9,American Society of Clinical Rheumatology, 9; C. L. Gaich, Eli Lilly and Company, 1,Eli Lilly and Company, 3; A. M. DeLozier, Eli Lilly and Company, 1,Eli Lilly and Company, 3; S. de Bono, Eli Lilly and Company, 1,Eli Lilly and Company, 3; D. E. Schlichting, Eli Lilly and Company, 1,Eli Lilly and Company, 3; T. Rooney, Eli Lilly and Company, 1,Eli Lilly and Company, 3; J. Liu, Eli Lilly and Company, 1,Eli Lilly and Company, 3; S. D. Beattie, Eli Lilly and Company, 1,Eli Lilly and Company, 3; M. Dougados, AbbVie, Pizer, Eli Lilly and Company, Novartis, UCB, Merck, Roche, BMS, UCB, 2,AbbVie, Pizer, Eli Lilly and Company, Novartis, UCB, Merck, Roche, BMS, UCB, 5.

To cite this abstract in AMA style:

Taylor PC, Wright GC, Gaich CL, DeLozier AM, de Bono S, Schlichting DE, Rooney T, Liu J, Beattie SD, Dougados M. Speed of Onset of Effect on Patient-Reported Outcomes Assessed through Daily Electronic Patient Diaries in the Baricitinib Phase 3 RA Clinical Program [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/speed-of-onset-of-effect-on-patient-reported-outcomes-assessed-through-daily-electronic-patient-diaries-in-the-baricitinib-phase-3-ra-clinical-program/. Accessed .

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