Tumour necrosis factor inhibitors versus combination intensive therapy with conventional disease modifying anti-rheumatic drugs in established rheumatoid arthritis: TACIT non-inferiority randomised controlled trial.
Bottom Line: Initial reductions in disease activity were greater with the biologic strategy, but these differences did not persist beyond six months.Remission was seen in 72 patients (44 with biologic strategy; 36 with alternative strategy); 28 patients had serious adverse events (18 and 10, respectively); six and 10 patients, respectively, stopped treatment because of toxicity.The alternative strategy reduced health and social care costs per patient by £3615 (€4930, $5585) for months 0-6 and £1930 for months 6-12.
Affiliation: Department of Rheumatology, King's College London School of Medicine, London SE5 9RJ, UK firstname.lastname@example.org.Show MeSH
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Mentions: Both groups had less disability, shown by falls in their scores on the health assessment questionnaire. Mean reductions were −0.30 (95% confidence interval −0.42 to −0.19) with the tumour necrosis factor strategy and −0.45 (−0.55 to −0.34) with the disease modifying drug strategy. Figure 2 shows that the difference between groups favoured the disease modifying drug strategy. The figure follows the recommendations of Piaggio and colleagues.24 It shows unadjusted regression coefficients with 95% confidence intervals. The non-inferiority margin is shown for the scores on the primary outcome health assessment questionnaire. The mean difference was −0.14 and the 95% confidence interval (−0.29 to 0.01) was below the prespecified non-inferiority boundary of 0.22. There were no pre-defined non-inferiority margins for the secondary outcome measures. Adjustment for baseline and demographic variables did not change this conclusion (appendix table C).
Affiliation: Department of Rheumatology, King's College London School of Medicine, London SE5 9RJ, UK email@example.com.