PMID- 23962455 OWN - NLM STAT- MEDLINE DCOM- 20140211 LR - 20220331 IS - 1468-2060 (Electronic) IS - 0003-4967 (Print) IS - 0003-4967 (Linking) VI - 73 IP - 1 DP - 2014 Jan TI - Head-to-head comparison of subcutaneous abatacept versus adalimumab for rheumatoid arthritis: two-year efficacy and safety findings from AMPLE trial. PG - 86-94 LID - 10.1136/annrheumdis-2013-203843 [doi] AB - OBJECTIVES: To compare over 2 years the safety, efficacy and radiographic outcomes of subcutaneous abatacept versus adalimumab, in combination with methotrexate (MTX), in patients with rheumatoid arthritis (RA). METHODS: AMPLE is a phase IIIb, 2-year, randomised, investigator-blinded study with a 1-year primary endpoint. Biologic-naive patients with active RA and an inadequate response to MTX were randomised to 125 mg abatacept weekly or 40 mg adalimumab bi-weekly, both with a stable dose of MTX. RESULTS: Of 646 patients randomised, 79.2% abatacept and 74.7% adalimumab patients completed year 2. At year 2, efficacy outcomes, including radiographic, remained comparable between groups and with year 1 results. The American College Rheumatology 20, 50 and 70 responses at year 2 were 59.7%, 44.7% and 31.1% for abatacept and 60.1%, 46.6% and 29.3% for adalimumab. There were similar rates of adverse events (AEs) and serious adverse events (SAEs). More serious infections occurred with adalimumab (3.8% vs 5.8%) including two cases of tuberculosis with adalimumab. There were fewer discontinuations due to AEs (3.8% vs 9.5%), SAEs (1.6% vs 4.9%) and serious infections (0/12 vs 9/19 patients) in the abatacept group. Injection site reactions (ISRs) occurred less frequently with abatacept (4.1% vs 10.4%). CONCLUSIONS: Through 2 years of blinded treatment in this first head-to-head study between biologic disease-modifying antirheumatic drugs in RA patients with an inadequate response to MTX, subcutaneous abatacept and adalimumab were similarly efficacious based on clinical, functional and radiographic outcomes. Overall, AE frequency was similar in both groups but there were less discontinuations due to AEs, SAEs, serious infections and fewer local ISRs with abatacept. FAU - Schiff, Michael AU - Schiff M AD - Department of Rheumatology, University of Colorado, , Denver, Colorado, USA. FAU - Weinblatt, Michael E AU - Weinblatt ME FAU - Valente, Robert AU - Valente R FAU - van der Heijde, Desiree AU - van der Heijde D FAU - Citera, Gustavo AU - Citera G FAU - Elegbe, Ayanbola AU - Elegbe A FAU - Maldonado, Michael AU - Maldonado M FAU - Fleischmann, Roy AU - Fleischmann R LA - eng SI - ClinicalTrials.gov/NCT00929864 PT - Clinical Trial, Phase III PT - Comparative Study PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20130820 PL - England TA - Ann Rheum Dis JT - Annals of the rheumatic diseases JID - 0372355 RN - 0 (Antibodies, Monoclonal, Humanized) RN - 0 (Antirheumatic Agents) RN - 0 (Immunoconjugates) RN - 7D0YB67S97 (Abatacept) RN - FYS6T7F842 (Adalimumab) RN - YL5FZ2Y5U1 (Methotrexate) SB - IM MH - Abatacept MH - Adalimumab MH - Adult MH - Antibodies, Monoclonal, Humanized/*administration & dosage/adverse effects MH - Antirheumatic Agents/*administration & dosage/adverse effects MH - Arthritis, Rheumatoid/diagnosis/*drug therapy MH - Drug Therapy, Combination MH - Female MH - Humans MH - Immunoconjugates/*administration & dosage/adverse effects MH - Injections, Subcutaneous MH - Male MH - Methotrexate/*administration & dosage/adverse effects MH - Middle Aged MH - Treatment Outcome PMC - PMC3888617 OTO - NOTNLM OT - DMARDs (Biologic) OT - Methotrexate OT - Rheumatoid Arthritis EDAT- 2013/08/22 06:00 MHDA- 2014/02/12 06:00 CRDT- 2013/08/22 06:00 PHST- 2013/08/22 06:00 [entrez] PHST- 2013/08/22 06:00 [pubmed] PHST- 2014/02/12 06:00 [medline] AID - annrheumdis-2013-203843 [pii] AID - 10.1136/annrheumdis-2013-203843 [doi] PST - ppublish SO - Ann Rheum Dis. 2014 Jan;73(1):86-94. doi: 10.1136/annrheumdis-2013-203843. Epub 2013 Aug 20.