Patient-Reported Outcomes from a Phase 3 Study of Baricitinib in Patients with Rheumatoid Arthritis with Inadequate Response to Conventional Synthetic Disease-Modifying Antirheumatic Drugs

Paul Emery¹, Carol L. Gaich², Amy M. DeLozier³, Stephanie de Bono^2,4, Jiajun Liu², Cecile Chang² and Maxime Dougados⁵, ¹Division of Rheumatic and Musculoskeletal Disease, University of Leeds, Leeds Institute of Molecular Medicine and LMBRU, Leeds, United Kingdom, ²Eli Lilly and Company, Indianapolis, IN, ³Lilly Corporate Center, Eli Lilly and Company, Indianapolis, IN, ⁴Eli Lilly and Company, Cookham, United Kingdom, ⁵Paris-Descartes University, Paris, France

Meeting: 2015 ACR/ARHP Annual Meeting

Date of first publication: September 29, 2015

Keywords: clinical trials, Janus kinase (JAK), patient-reported outcome measures and rheumatoid arthritis (RA)

Session Information

Date: Tuesday, November 10, 2015

Session Title: Rheumatoid Arthritis - Small Molecules, Biologics and Gene Therapy Poster III

Session Type: ACR Poster Session C

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

Background/Purpose:

Baricitinib (bari) is an
oral Janus kinase (JAK) 1 /JAK2 selective inhibitor, representing a potentially
effective treatment for patients with moderately to severely active rheumatoid
arthritis (RA). This study evaluated the effect of bari 2 and 4 mg on
patient-reported outcomes (PROs) in patients with RA with an inadequate response
or intolerance to conventional synthetic disease-modifying antirheumatic drugs
(csDMARDs), including methotrexate, and who have not previously been treated
with a biologic DMARD (bDMARD). This study has previously shown that bari
improved signs and symptoms of RA (Dougados M et al, Ann Rheum Dis
2015;74(S2):79).

Methods:

In this multicenter,
double-blind, double-dummy, outpatient study, patients aged ≥18 yrs with
active RA were randomized in a 1:1:1 ratio to placebo (PBO) or bari (2 or 4 mg,
once a day) for 24 weeks. PRO measures assessed with daily patient diaries
through 12 weeks included duration and severity of morning joint stiffness
(MJS), worst tiredness and worst joint pain. PROs assessed at study visits included
the Health Assessment Questionnaire-Disability Index (HAQ-DI), Functional
Assessment of Chronic Illness Therapy Fatigue (FACIT-F) scale, Short Form 36 (SF–36), European
Quality of Life-5 Dimensions-5 Level (EQ-5D), Patient’s Global Assessment of
Disease Activity, and patient’s assessment of pain. PRO data from treatment
groups were compared at Week 12 for diary data and at Weeks 12 and 24 for study
visits. Analyses were conducted on an intention-to-treat basis.

Results:

684 patients were randomized. After 12 and 24
weeks of therapy, bari-treated patients achieved statistically significant
improvements in most PROs compared with PBO (Tables). For PROs collected via
daily patient diaries, bari-treated patients achieved statistically significant
improvements at Week 12 in MJS duration, severity, tiredness, and joint pain.

Conclusion:

In this phase 3 study of
patients with RA with an inadequate response to csDMARDs, and not previously
treated with a bDMARD, treatment with bari produced significant clinical
improvements in disease activity. This analysis showed that treatment with bari
also resulted in significant improvement in patient-reported outcomes across
different domains including pain, functional disability and fatigue.

Disclosure: P. Emery, Abbott/Abbvie, Bristol-Myers Squibb, Pfizer, UCB, MSD, Roche, Novartis, Samsung, Takeda, Lilly, 5; C. L. Gaich, Eli Lilly and Company, 1,Eli Lilly and Company, 3; A. M. DeLozier, Eli Lilly and Company, 3; S. de Bono, Eli Lilly and Company, 3,Eli Lilly and Company, 1; J. Liu, Eli Lilly and Company, 1,Eli Lilly and Company, 3; C. Chang, Eli Lilly and Company, 1,Eli Lilly and Company, 3; M. Dougados, None.

To cite this abstract in AMA style:

Emery P, Gaich CL, DeLozier AM, de Bono S, Liu J, Chang C, Dougados M. Patient-Reported Outcomes from a Phase 3 Study of Baricitinib in Patients with Rheumatoid Arthritis with Inadequate Response to Conventional Synthetic Disease-Modifying Antirheumatic Drugs [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/patient-reported-outcomes-from-a-phase-3-study-of-baricitinib-in-patients-with-rheumatoid-arthritis-with-inadequate-response-to-conventional-synthetic-disease-modifying-antirheumatic-drugs/. Accessed July 23, 2019.

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