AMPLE: Head-to-Head Comparison of Adalimumab and Abatacept Shows Similar Efficacy, Safety

VBCR - August 2013, Volume 2, No 4 - EULAR Annual Meeting

By Phoebe Starr

Madrid, Spain—The first randomized, controlled, head-to-head comparison of 2 biologics showed similar efficacy and safety for adalimumab (Humira) and for abatacept (Orencia) in the treatment of patients with rheumatoid arthritis (RA). As a result of the AMPLE (Abatacept Versus Ada­limumab Comparison in Biologic-Naive RA Subjects with Background Methotrexate) trial, rheumatologists can be comfortable prescribing either drug to patients with RA, experts say.

“The robust data set demonstrates that subcutaneous abatacept and adalimumab are equally efficacious in clinical, functional, and radiographic outcomes in moderate-to-severe RA. This helps clinicians make an informed choice of a biologic agent when an incomplete response to methotrexate occurs. The study is a great leap forward, showing that another treatment is as effective as adalimumab,” said lead investigator Michael H. Schiff, MD, Clinical Professor of Medicine, Rheumatology Division, University of Colorado School of Medicine, Denver, who presented these results at the 2013 European League Against Rheumatism (EULAR) annual meeting.

A subanalysis of the cost-effectiveness of these drugs was also presented at the meeting.

AMPLE is a phase 3b randomized, investigator-blinded study of 646 biologic-naïve patients with active RA receiving a stable dose of background methotrexate. Participants were randomized to 1 year of treatment with subcutaneous abatacept or subcutaneous adalimumab.

The 1-year results of AMPLE were presented last year at EULAR, and showed that both drugs achieved comparable efficacy for the signs and symptoms of RA: 64.8% of the abatacept arm and 63.4% of the adalimu­mab arm achieved a response of at least a 20% American College of Rheumatology (ACR20) criteria for improvement. Radiographic progression was inhibited in approximately 85% of patients in both arms.

The 2-year results presented at EULAR 2013 demonstrated that responses were similar between the 2 arms and were maintained over the longer-term. ACR20 was achieved in 60% of the abatacept arm versus 59% of the adalimumab arm, ACR50 was achieved in approximately 45% of patients in both arms, and ACR70 was achieved in approximately 30% of both arms. ACR90 was observed in 14.5% of the patients treated with abatacept versus in 8.2% of those who received adalimumab. Overall, 85% of patients in each arm remained free of radiographic progression for the study duration.

Safety was similar in both arms. Fewer treatment discontinuations resulting from adverse events (3.8%) were seen in the abatacept arm versus 9.5% in the adalimumab arm. Discontinuation resulting from serious adverse events was reported in 1.6% of patients receiving abatacept versus 4.9% of patients in the adalimumab arm. The rate of infections leading to discontinuation was very low.

The slight numerical edge for abatacept regarding adverse events was not clinically meaningful, according to EULAR’s Chairperson of the Scientific Programme Committee, Ulf Müller- Ladner, MD, PhD, of the Justus-Liebig-Universität Giessen, and the Kerckhoff Klinik, Germany.

“The side effects of both drugs were in line with previous experience and, therefore, these safety data shouldn’t affect decision-making. We can use both of these 2 subcutaneous agents. This study provides proof for what we are already doing with RA patients,” Dr Müller-Ladner stated.

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Last modified: May 21, 2015
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