A new, post-hoc study has reported that adalimumab, used as monotherapy, led to positive clinical, functional, and radiographic outcomes in patients with rheumatoid arthritis (RA) for up to 3 years in more than half of patients who reached low disease activity (LDA) following combination therapy.
Adalimumab, used as monotherapy, led to positive clinical, functional, and radiographic outcomes in patients with rheumatoid arthritis (RA) for up to 3 years in more than half of patients who reached low disease activity (LDA) following combination therapy, according to a new, posthoc study.
The researchers drew from the open-label extension of the phase 3 PREMIER study, in which patients with RA were randomized to receive adalimumab monotherapy, methotrexate monotherapy, or combination therapy with methotrexate and adalimumab, reported The Center for Biosimilars®. All patients who completed the 2-year study were eligible for the open-label extension, in which they received adalimumab at 40 mg every other week for up to 8 years, with the option to add methotrexate if deemed necessary by the investigator. In total, 183 patients enrolled in the open-label extension, and 140 of them (77%) were in an LDA state at year 2.
According to the current, posthoc study, 84 patients (60%) used adalimumab alone, while 56 (40%) reinitiated methotrexate in combination with adalimumab during the extension period. A total of 60 patients in monotherapy and 44 patients in combination therapy completed 3 years of treatment. Patients 65 or older were more likely to add methotrexate, and those who reinitiated methotrexate generally had higher measures of disease activity than those who remained on adalimumab monotherapy.
Keystone EC, Breedveld FC, Kupper H, Li Y, Florentius S, Sainsbury I. Long-term use of adalimumab as monotherapy after attainment of low disease activity with adalimumab plus methotrexate in patients with rheumatoid arthritis. RMD Open. 2018;4:e000637. doi: 10.1136/rmdopen-2017-000637.