Artikel
MRI results from the AVERT study: a randomized, active-controlled trial to evaluate induction of remission and maintenance of drug-free remission using abatacept in combination with methotrexate or as monotherapy in patients with early RA
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Autoren
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C. Peterfy
- Spire Sciences, Inc., Boca Raton, United States of America
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Gerd-Rüdiger Burmester
- Charité - Universitätsmedizin Berlin, Medizinische Klinik mit Schwerpunkt Rheumatologie und klinische Immunologie, Berlin
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Vivian Bykerk
- Hospital for Special Surgery, New York, USA
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Bernard Combe
- Service d’Immuno-Rheumatologie, Montpellier, France
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D. Furst
- University of California at Los Angeles, Los Angeles, United States of America
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Tom Huizinga
- Leiden University Medical Center, Department of Rheumatology, Leiden, The Netherlands
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Chetan Karyekar
- Bristol-Myers Squibb, Princeton, USA
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D. Wong
- Bristol-Myers Squibb, Princeton, United States of America
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Philip Conaghan
- University of Leeds, Section of Musculoskeletal Disease, Leeds, United Kingdom
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Paul Emery
- University of Leeds, Division of Rheumatic & Musculoskeletal Disease, Leeds, United Kingdom
| Veröffentlicht: | 12. September 2014 |
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Gliederung
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Background: AVERT (Assessing Very Early Rheumatoid arthritis Treatment) is a Phase IIIb, randomized, active-controlled trial to evaluate the efficacy and safety of abatacept (ABA) in combination with methotrexate (+ MTX) in patients with early RA. We assessed joint damage progression by magnetic resonance imaging (MRI) in patients with early RA from the AVERT study who were treated with ABA + MTX or ABA monotherapy, compared with MTX alone.
Methods: MTX-naïve, anti-CCP2+ patients with early RA (active synovitis in ≥2 joints for ≥8 weeks, DAS28 [CRP] >3.2 and onset of symptoms within ≤2 years) were included. Patients were randomized to 12 months of weekly subcutaneous ABA 125 mg + MTX, ABA 125 mg monotherapy or MTX alone. Patients with DAS28 (CRP) <3.2 at Month 12 entered a 12-month withdrawal period with no treatment. All patients with protocol-defined flare after Month 15 could receive open-label ABA + MTX. Gadolinium-enhanced MRI of the dominant hand-wrist was performed on all patients at baseline and at Months 6, 12, 18 and 24. Changes from baseline in synovitis, osteitis and bone erosion MRI scores were assessed up to Month 18 in this analysis.
Results: During the 12-month treatment period, benefits in synovitis, osteitis and erosion scores were numerically greater for ABA + MTX than for MTX alone; while numerically greater benefits were observed in synovitis and osteitis scores for ABA monotherapy than for MTX alone (Table 1 [Tab. 1]). A post hoc analysis of patients who maintained DAS28 (CRP) <2.6 to Month 18 after treatment withdrawal did not show evidence of MRI progression compared with Month 12 in those patients.
Conclusion: Consistent with the clinical outcomes of the AVERT study in patients with early RA with high disease activity, there were greater reductions in MRI outcomes with abatacept treatment in combination with MTX than with MTX alone. MRI changes with abatacept monotherapy treatment were intermediate between abatacept in combination with MTX and MTX treatment alone.
