medwireNews: A post-hoc analysis of two randomized trials suggests that rheumatoid arthritis (RA) patients who are treated with tocilizumab derive greater benefits in patient-reported outcomes (PROs) than methotrexate- or adalimumab-treated patients.
Graeme Jones, from the University of Tasmania in Hobart, Australia, and fellow researchers analyzed PRO data from the phase III AMBITION trial, which compared the interleukin-6 inhibitor tocilizumab with methotrexate monotherapy in patients with moderate-to-severe active RA, and the phase IV ADACTA trial of tocilizumab versus the tumor necrosis factor inhibitor adalimumab in patients with severe disease.
Although treatment with all three drugs “resulted in substantial and clinically meaningful improvements in PROs,” tocilizumab monotherapy was “more effective overall” compared with methotrexate or adalimumab monotherapy, say the researchers.
In AMBITION, the 265 tocilizumab-treated patients reported significantly greater improvements in Health Assessment Questionnaire Disability Index, Functional Assessment of Chronic Illness Therapy-Fatigue, and Short Form-36 (SF-36) physical component summary scores from baseline to week 24 than the 259 participants receiving methotrexate, with corresponding least squared mean changes of 0.7 versus 0.5 points, 8.7 versus 5.7 points, and 9.8 versus 7.8 points.
And in ADACTA, the 163 patients in the tocilizumab group reported significantly larger improvements in patient global assessment (42.3 versus 31.8 points) and pain (40.1 versus 28.7 points) at the 24-week follow-up compared with 162 adalimumab-treated patients.
Moreover, patients treated with tocilizumab in both trials reported higher mean SF-36 scores across all domains compared with those in the methotrexate or adalimumab groups, and the reported scores in tocilizumab-treated patients were closer to those in age- and sex-matched healthy controls.
“Results of these trials indicate that it is now possible for patients with RA to achieve PRO scores that more closely approach those reported by healthy populations,” write the researchers in RMD Open, noting that the “reported improvements in PROs correlated with significant improvements in [disease activity].”
Jones and colleagues caution that the study was limited by the use of adalimumab monotherapy in the ADACA trial, because “it is well recognised that [adalimumab] in combination with [methotrexate] is more effective than [adalimumab] monotherapy.”
“However, for patients who cannot tolerate [methotrexate], the results presented here suggest that [tocilizumab] monotherapy is more effective than [adalimumab] monotherapy for improving PROs,” they conclude.
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