Article
Induction of clinical remission followed by drug-free withdrawal with abatacept combination and monotherapy in early RA: results from the AVERT (Assessing Very Early Rheumatoid arthritis Treatment) study over 18 months
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Authors
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Paul Emery
- University of Leeds, Division of Rheumatic & Musculoskeletal Disease, Leeds, United Kingdom
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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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Emilie Barre
- Bristol-Myers Squibb, Braine-L'Alleud, Belgium
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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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Tom Huizinga
- Leiden University Medical Center, Department of Rheumatology, Leiden, The Netherlands
| Published: | September 12, 2014 |
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Outline
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Background: AVERT is a Phase IIIb, randomized, active-controlled study to evaluate the efficacy and safety of subcutaneous (SC) abatacept (ABA) in patients with early RA. We assessed ABA+MTX or ABA monotherapy in inducing clinical remission at 12 months and maintaining it following withdrawal of all RA treatment in patients with early RA.
Methods: MTX-naïve, anti-CCP2+ patients with early RA (active synovitis in ≥2 joints for ≥8 weeks; DAS28 [CRP] >3.2; onset of symptoms ≤2 years) were included. Patients were randomized to 12 months of weekly SC ABA 125 mg + MTX, ABA 125 mg monotherapy or MTX alone. Patients with DAS28 (CRP) <3.2 at Month 12 entered the 12-month withdrawal period. Co-primary endpoints compared ABA+MTX versus MTX in patients achieving DAS28 (CRP) <2.6 at (1) 12 months and (2) 12 and 18 months.
Results: 351 patients with early RA, highly active disease and poor prognosis entered the study. At 12 months, 60.9, 42.5 and 45.2% achieved DAS28 (CRP) <2.6 (ABA+MTX, ABA and MTX, respectively) (Figure). Odds ratio (OR; 95% CI) for ABA+MTX vs MTX: 2.01 (1.18, 3.43) with p=0.01 and for ABA vs MTX: 0.92 (0.55, 1.57). Following treatment withdrawal, most patients discontinued (177/223; 79.4%). Rates of patients achieving DAS28 (CRP) <2.6 at both 12 and 18 months were 14.8, 12.4 and 7.8% for ABA+MTX, ABA and MTX, respectively; OR (95% CI) for ABA+MTX vs MTX: 2.51 (1.02, 6.18), p=0.045 and for ABA vs MTX: 2.04 (0.81, 5.14). In a post hoc analysis, patients with DAS28 (CRP) <2.6 at both Month 12 and 18 generally had lower mean symptom duration, DAS28 (CRP), or HAQ score at baseline, or DAS28 (CRP) <2.6 for longer periods while on drug, compared with patients who achieved only DAS28 (CRP) <2.6 at 12 months. The safety profile of ABA+MTX was comparable with MTX. Figure 1 [Fig. 1].
Conclusion: In patients with highly active early RA with poor prognosis, abatacept + MTX resulted in significantly higher rates of remission and comparable safety vs MTX alone at 12 months. A small but significantly higher number of patients treated with abatacept + MTX were able to maintain drug-free remission compared with MTX.
