Results from a 10-year study show that even a one-year delay in starting therapy with adalimumab plus methotrexate for longstanding rheumatoid arthritis (RA) patients may result in reduced effectiveness - and a lost chance to prevent irreversible joint damage.
Keystone EC, van der Heijde D, Kavanaugh A et al. Clinical, Functional, and Radiographic Benefits of Longterm Adalimumab Plus Methotrexate: Final 10-year Data in Longstanding Rheumatoid Arthritis. J Rheum (2013) Epub ahead of print. DOI: 10.3899
Results from a 10-year study show that even a one-year delay in starting therapy with adalimumab plus methotrexate (MTX) for longstanding rheumatoid arthritis (RA) patients may result in reduced effectiveness - and a lost chance to prevent irreversible joint damage.
An international team of researchers reports that patients with established RA started on combination therapy at the outset of the DE019 clinical trial show lower disease activity, better function, and less radiographic progression over 10 years than those whose treatment was delayed until the extension phase of the trial a yeaer later.
The original DE019 trial randomized 619 mostly female patients with moderate to severe RA not adequately responsive to MTX to 12 months of either placebo, adalimumab 20 mg weekly, or 40 mg every other week (EOW) plus concomitant MTX.
After a year, those who entered the open-label extension were given 40 mg adalimumab EOW and MTX. Of the 457 patients who initially entered the open-label extension, 202 completed it. Overall, there was no change in the expected safety profile.
Among the completers, 74.1% achieved a low disease activity (LDA) state at 10 years, 59% had a DAS28-CRP remission state and 33.2% reached a SDAI remission state, with 42.2% showing improved functional outcomes from baseline to 10 years.
However, those who began treatment at 9 years had more persistently swollen and/or tender joints, higher cumulative DAS28-CRP disease activity, greater HAQ-DI functional impairment, and lower ACR50/ACR70/ACR90 response rates. More than half (51%) of those on therapy for 10 years showed no radiographic progression, versus 39% of those whose treatment was delayed.
While the delayed treatment group maintained their clinical response levels, the results suggest that even for patients with established RA, there is a window of opportunity to prevent lasting joint damage, the researchers say.