EU Clears Abatacept (Orencia) for MTX-Naive Patients With RA

Megan Brooks


September 06, 2016

The European Commission has approved abatacept (Orencia, Bristol-Myers Squibb) by intravenous (IV) infusion or subcutaneous injection in combination with methotrexate (MTX) for adults with highly active or progressive rheumatoid arthritis (RA) who have not previously been treated with MTX, the company has announced.

The Committee for Medicinal Products for Human Use of the European Medicines Agency recommended adding this indication in July, as reported by Medscape Medical News.

Abatacept is already approved in the European Union in combination with MTX for adults with moderate to severe active RA who do not respond adequately to treatment with one or more disease-modifying antirheumatic drugs (DMARDs), including MTX or a tumor-necrosis factor-α inhibitor.


The European Commission's approval for the new indication was based on data from two phase 3 studies and marks the first time that MRI-detected structural and inflammatory measures of disease severity are cited as support for the indication, the company says.

AGREE (Abatacept study to Gauge Remission and joint damage progression in MTX-naive patients with Early Erosive RA) was a 12-month, double-blind, randomized study of MTX-naive patients with early, rapidly progressing RA. Patients were treated with abatacept IV plus MTX or MTX alone.

AGREE met its co-primary endpoints as defined by the proportion of patients achieving Disease Activity Score 28-C-Reactive Protein (DAS28-CRP) less than 2.6 at 1 year (41% with abatacept IV plus MTX vs 23% with MTX alone; P < .001) and inhibition of radiographic progression at 1 year (mean change in total Sharp score, 0.6 vs 1.1; P = .04).

The second phase 3 study, known as AVERT (Assessing Very Early Rheumatoid Arthritis Treatment), compared abatacept 125 mg subcutaneous plus MTX combination therapy, abatacept 125 mg subcutaneous monotherapy and MTX monotherapy in induction of DAS28-defined remission after 12 months of treatment in adults with moderate to severe, active, early RA (mean DAS28-CRP, 5.4; mean symptom duration <6.7 months) who had not previously been treated with MTX or other DMARDs (MTX-naive).

Patients in AVERT (as in AGREE) also had factors that suggested their disease would progress rapidly (positive for anti-cyclic citrullinated peptide antibodies and/or rheumatoid factor, with presence of baseline joint erosions).

At 12 months, significantly more patients receiving combination therapy achieved DAS28-defined remission compared with those receiving MTX only (60.9% vs 45.2%).

The abatacept plus MTX combination was also more effective than MTX alone at 12 months for Boolean remission (37.0% vs 22.4%), Clinical Disease Activity Index remission (42% vs 27.6%), and Simple Disease Activity Index remission (42% vs 25%).

The most commonly reported adverse events, which occurred at a rate of at least 10% in patients who took abatacept in the adult RA clinical studies, were headache, upper respiratory tract infection, nasopharyngitis, and nausea.

With this approval, abatacept becomes the first biologic therapy with an indication in the European Union specifically applicable to the treatment of MTX-naive patients with RA who have highly active and progressive disease, the company says.

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