Artikel
Baricitinib Versus Placebo or Adalimumab in Patients with Active Rheumatoid Arthritis (RA) and an Inadequate Response to Background Methotrexate (MTX) Therapy: Results of a 52-Week Phase 3 Study
Suche in Medline nach
Autoren
-
Peter Taylor
- Nuffield Department of Orthopaedics, University of Occupational & Environmental Health, Kennedy Institute of Rheumatology, University of Oxford, Oxford, UK
-
Ed Keystone
- The Rebecca MacDonald Centre, Mount Sinai Hospital, University of Toronto, Toronto, Canada
-
Desiree van der Heijde
- Leiden University Medical Center, Department of Rheumatology, Leiden, The Netherlands
-
Yoshiya Tanaka
- School of Medicine, University of Occupational & Environmental Health, Kitakyushu, Japan
-
Taeko Ishii
- Eli Lilly and Company, Indianapolis, USA
-
Kahaku Emoto
- Eli Lilly and Company, Indianapolis, USA
-
Lili Yang
- Eli Lilly and Company, Indianapolis, USA
-
Vipin Arora
- Eli Lilly and Company, Indianapolis, USA
-
Carol Gaich
- Eli Lilly and Company, Indianapolis, USA
-
Terence Rooney
- Eli Lilly and Company, Indianapolis, USA
-
Douglas Schlichting
- Eli Lilly and Company, Indianapolis, USA
-
William Macias
- Eli Lilly and Company, Indianapolis, USA
-
Stephanie de Bono
- Eli Lilly and Company, Indianapolis, USA
-
Michael E. Weinblatt
- Brigham and Women’s Hospital, Division of Rheumatology, Immunology and Allergy, Boston, United States of America
-
Andrea Rubbert-Roth
- Universitätsklinikum Köln, Klinik I für Innere Medizin, Köln
| Veröffentlicht: | 29. August 2016 |
|---|
Gliederung
Text
Background: In phase 3 studies, baricitinib improved disease activity in patients with active RA and an inadequate response (IR) to DMARDs. We report results from a 52-week study of baricitinib in MTX-IR RA patients.
Methods: Patients with active RA (TJC≥6 & SJC≥6 & hsCRP≥6mg/L) despite stable background MTX were randomized 3:3:2 to placebo, baricitinib 4mg once daily (QD), or adalimumab 40mg biweekly (Q2W). Non-responders were rescued from Wk16. At Wk24, patients on placebo switched to baricitinib 4mg QD. The primary endpoint was ACR20 response at Wk12 for baricitinib vs. placebo. Major secondary endpoints included baricitinib vs. adalimumab (ACR20 and DAS28-CRP at Wk12) and baricitinib vs. placebo (mTSS at Wk24).
Results: Of 1305 randomized patients, 83%, 88% and 87% completed Wk52 in placebo, baricitinib and adalimumab groups, respectively. Rescue rates were 27%, 9% and 15% for placebo, baricitinib and adalimumab, respectively. ACR20 response at Wk12 was higher for baricitinib vs. placebo (70% vs. 40%;p≤.001). At Wk12/Wk24, significant improvements in ACR20/50/70 & HAQ-DI response rates, and DAS28, CDAI, and SDAI low disease activity and remission rates, were seen for baricitinib vs. placebo, as early as Wk1. Change in mTSS at Wk24 was lower for baricitinib vs. placebo (0.41 vs. 0.90;p≤.001). Baricitinib was superior to adalimumab in ACR20 response rates and improvement in DAS28-CRP at Wk12/Wk24/Wk52. Compared to placebo, daily measures of morning joint stiffness duration/severity, worst tiredness, and joint pain were significantly improved for baricitinib, as early as Wk1. By Wk52, rates of treatment-emergent adverse events, including infections, were higher for baricitinib and adalimumab compared to placebo. Serious adverse events rates were similar for baricitinib and lower for adalimumab vs. placebo; serious infection rates were similar across groups. Five deaths occurred (placebo, n=1; baricitinib, n=2; adalimumab, n=1; placebo rescued to baricitinib, n=1). Few malignancies were reported (placebo, n=3; baricitinib, n=3; placebo rescued to baricitinib, n=1). One tuberculosis case occurred (adalimumab). Lab abnormalities were consistent with other baricitinib phase 3 studies; few led to discontinuation.
Conclusion: In patients with MTX-IR RA, once-daily oral baricitinib was associated with significant clinical improvements compared to placebo and to adalimumab, with an acceptable safety and tolerability profile.
