Artikel
Baricitinib, Methotrexate, or Baricitinib Plus Methotrexate in Patients with Early Rheumatoid Arthritis Who Had Received Limited or No Treatment with Disease-Modifying Anti-Rheumatic Drugs (DMARDs): Phase 3 Trial Results
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Autoren
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Roy Fleischmann
- Metroplex Clinical Research Center, Dallas, Texas, USA
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Tsutomu Takeuchi
- Keio University School of Medicine, Tokyo, Japan
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Douglas Schlichting
- Eli Lilly and Company, Indianapolis, USA
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William Macias
- Eli Lilly and Company, Indianapolis, USA
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Terence Rooney
- Eli Lilly and Company, Indianapolis, USA
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Sirel Gurbuz
- Eli Lilly and Company, Indianapolis, USA
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Ivaylo Stoykov
- Eli Lilly and Company, Brussel, Belgium
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Scott Beattie
- Eli Lilly and Company, Indianapolis, USA
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Wen-Ling Kuo
- Eli Lilly and Company, Indianapolis, USA
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Michael Schiff
- University of Colorado School of Medicine, Rheumatology Division, Denver, USA
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Jörn Kekow
- Fachkrankenhaus für Rheumatologie und Orthopädie Vogelsang-Gommern, Otto-von-Guericke-Universität Magdeburg, Vogelsang-Gommern
| Veröffentlicht: | 29. August 2016 |
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Gliederung
Text
Background: In phase 3 studies, baricitinib improved disease activity with a satisfactory safety profile in patients with moderately-to-severely active RA who were inadequate responders to DMARDs. We report results from a phase 3 study of baricitinib administered as monotherapy or in combination with methotrexate (MTX) to patients with early active RA and limited or no prior DMARD treatment.
Methods: Patients with active RA (TJC & SJC ≥6, hsCRP ≥3.6mg/L) and no previous DMARD treatment other than ≤3 doses of MTX were randomized to MTX, baricitinib 4mg once-daily (QD), or baricitinib 4mg QD+MTX for up to 52 weeks (wks). MTX dose (±baricitinib) was up-titrated from 10 to 20mg once-weekly over 8 wks. Rescue was not allowed prior to Wk24, the time point for primary and all major secondary efficacy endpoints. The primary objective evaluated non-inferiority of baricitinib 4mg monotherapy to MTX on ACR20 at Wk24.
Results: Of 584 randomized patients, 87%, 91%, and 89% completed Wk24 in the MTX, baricitinib 4mg monotherapy, and baricitinib 4mg+MTX groups, respectively. ACR20 response at Wk24 was higher with baricitinib 4mg monotherapy vs. MTX (77% vs. 62%; p≤.01). Compared to MTX, baricitinib 4mg monotherapy produced significantly greater improvements in multiple secondary measures of disease activity, many as early as Wk1. Clinical remission was seen in significantly (p≤.05) higher proportions of patients treated with baricitinib 4mg (±MTX) compared to MTX alone. Rates of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were similar across groups. Through 24wks, 2 (1.0%), 6 (3.8%) and 14 (6.5%) patients discontinued because of an adverse event in the MTX, baricitinib 4mg monotherapy, and baricitinib 4mg+MTX groups, respectively. No gastrointestinal perforations occurred. Laboratory abnormalities were generally less frequent in the baricitinib 4mg group than in either the MTX or baricitinib 4mg+MTX groups.
Conclusion: In patients with early RA, all treatment groups experienced improvements in disease activity, with baricitinib 4mg monotherapy producing significantly larger and more rapid improvements and higher rates of clinical remission compared to MTX monotherapy, with a satisfactory safety profile. MTX addition to baricitinib 4mg did not increase the benefit observed with baricitinib monotherapy.
