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In patients with inadequate response to methotrexate, the
addition of tofacitinib or adalimumab was equally effective and more useful
than switching to tofacitinib monotherapy.
Tofacitinib plus Methotrexate combination treatment was non-inferior to Adalimumab plus Methotrexate combination treatment among RA patients who showed an inadequate response to methotrexate, findings from a recent trial published in “The Lancet” Journal. In addition, the Tofacitinib monotherapy failed to show non-inferiority to either combination.
Rheumatoid
arthritis (RA) is a persistent inflammatory disease that influences about 1% of
the world's population. This severe condition is managed by certain
Conventional and Biological Disease-modifying anti-rheumatic drugs (cDMARDs
& bDMARDs). The bDMARDs are prescribed when patients fail to respond to
cDMARDs. One such bDMARDs is tofacitinib. Tofacitinib is an inhibitor of Janus
kinases. This is an approved drug for RA treatment. The efficacy and safety of Tofacitinib were
investigated through ORAL (Oral Rheumatoid Arthritis) trials. Now scientists
aimed to determine the comparative efficacy of tofacitinib monotherapy,
adalimumab plus methotrexate, and tofacitinib plus methotrexate for rheumatoid
arthritis treatment among patients having an inadequate response to
methotrexate (cDMARDs) in the past. They conducted a 1 year, double-blind,
non-inferiority, head-to-head, phase 3b/4, randomized controlled Oral Rheumatoid
Arthritis trial (ORAL) trial for evaluation.
A total of 1146 patients of age 18 or older with an active rheumatoid arthritis despite methotrexate therapy involved in the study. The patients were categorized randomly during the treatment. Out of 1146 patients,384 received tofacitinib monotherapy (5 mg twice daily orally); 376 received tofacitinib plus methotrexate 5 mg twice daily orally) and 386 received adalimumab plus methotrexate treatment (40 mg every other week subcutaneously). The whole trial was conducted at 194 centres in 25 countries. Eligible patients received live zoster vaccine at investigators' discretion. The patients who obtained 50% of an American College of Rheumatology response (ACR50) at 6 months in the full analysis set was considered as the primary endpoint. A full analysis set involved patients who were randomly selected to a group and obtained at least one dose of the study treatment. The trail group's non-inferiority was exhibited if the lower bound of the 98·34% CI of the difference between comparators was greater than −13·0%.
One forty seven patients with tofacitinib monotherapy, 173 patients with
tofacitinib plus methotrexate, and 169 patients with adalimumab plus
methotrexate were successful to achieve ACR50 response at 6 months. Some of the
patients, 23 of tofacitinib monotherapy group, 26 of tofacitinib plus
methotrexate group and 36 of adalimumab plus methotrexate group discontinued
the treatment due to adverse events. Two of the patients who were receiving
tofacitinib monotherapy died. However, no new or unexpected safety issue
noticed during trial up to 1 year. The non-inferiority between groups were
noticed for tofacitinib plus methotrexate versus adalimumab plus methotrexate
only (difference 2% [98·34% CI −6 to 11]).
The Lancet
Efficacy and safety of tofacitinib monotherapy, tofacitinib with methotrexate, and adalimumab with methotrexate in patients with rheumatoid arthritis (ORAL Strategy): a phase 3b/4, double-blind, head-to-head, randomised controlled trial
Roy Fleischmann et al.
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