Tocilizumab vs. Methotrexate in Rheumatoid Arthritis Save
A large randomized rheumatoid arthritis (RA) clinical trial compared subcutaneous tocilizumab (TCZ) vs oral methotrexate (MTX) vs. the combination of subcutaneous TCZ and MTX, and showed that TCZ was superior to MTX, either given as TCZ monotherapy or in combination with MTX.
To evaluate the efficacy and safety of subcutaneous tocilizumab monotherapy, tocilizumab-methotrexate, and methotrexate alone for patients with RA.
This double-blind, large-scale phase 3 randomized multicenter clinical trial from China enrolled a total of 340 adult RA patients (with an inadequate response to csDMARDs) in a 24-week double-blind treatment phase, a 24-week extension phase, and 8 additional weeks of safety follow-up. Patients were randomized 2:2:1 to either MTX-placebo (PBO), or TCZ-PBO, or TCZ-MTX. The primary endpoint was the percentage of those achiving a ACR20 response at week 24. At week 24, patients achieving a DAS28) <3.2 continued their double-blind treatment; while those with a DAS28 > 3.2 received open-label TCZ-MTX. Ssbcutaneous TCZ (162 mg) was given once every 2 weeks; and oral MTX (10-25 mg) was given once weekly.
The study population was mostly women (86.5%) with a mean age of 47.5 years. The week 24 ACR20 response rate significantly (P < .001) favored the TCZ-MTX group:
- TCZ-MTX - 52.9%
- TCZ-PBO - 50.0%
- MTX-PBO - 25.0%
At week 48, responders on TCZ-PBO or TCZ-MTX maintained efficacy out to week 48. And week 24 nonresponders who were switched to TCZ-MTX improved disease status. No new safety signals were observed for tocilizumab.
While equivalent efficacy was seen for TCZ monotherapy and TCZ-MTX combo therapy, these were superior to MTX monotherapy.
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I don’t see the above as equivalent efficacy of monotherapy TCZ vs combination. The DAS graph above, while not powered to show differences, shows clear trends (based on confidence intervals) that combo did work better than mono. I agree this is some of the best monotherapy data available, but MTX seems to add something in particular potentially for deeper responses which would account for the differences in absolute DAS without seeing a difference in ACR20.
"Patients were eligible for inclusion if they had received a diagnosis of RA (for ≥6 months), had received methotrexate (for ≥12 weeks) and experienced treatment failure of at least 1 csDMARD (including methotrexate)" citation from the paper. So, study addressing a non-naive, stablished (mean (SD) duration of RA=8.7(7.4)) RA population.....
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The author has no conflicts of interest to disclose related to this subject
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