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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.

Scott DL, Ibrahim F, Farewell V, O'Keeffe AG, Walker D, Kelly C, Birrell F, Chakravarty K, Maddison P, Heslin M, Patel A, Kingsley GH - BMJ (2015)

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.

View Article: PubMed Central - PubMed

Affiliation: Department of Rheumatology, King's College London School of Medicine, London SE5 9RJ, UK d.scott1@nhs.net.

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Fig 2 Observed treatment differences for primary and secondary outcome measures in study in patients with rheumatoid arthritis randomised to treatment with combinations of disease modifying drugs or tumour necrosis factor inhibitors. Scales and direction of change for different outcome measures vary: health assessment questionnaire ranges from 0-3, higher scores are worse, and positive differences favour tumour necrosis factor strategy; EQ5D-3L ranges from 0-1, higher scores are better, and negative differences favour tumour necrosis factor strategy; SF-36 physical component score and mental component score range from 0-100, higher scores are better, and negative differences favours tumour necrosis factor strategy; Larsen score ranges from 0-200, higher scores are worse, and positive differences favours tumour necrosis factor strategy
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fig2: Fig 2 Observed treatment differences for primary and secondary outcome measures in study in patients with rheumatoid arthritis randomised to treatment with combinations of disease modifying drugs or tumour necrosis factor inhibitors. Scales and direction of change for different outcome measures vary: health assessment questionnaire ranges from 0-3, higher scores are worse, and positive differences favour tumour necrosis factor strategy; EQ5D-3L ranges from 0-1, higher scores are better, and negative differences favour tumour necrosis factor strategy; SF-36 physical component score and mental component score range from 0-100, higher scores are better, and negative differences favours tumour necrosis factor strategy; Larsen score ranges from 0-200, higher scores are worse, and positive differences favours tumour necrosis factor strategy

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).


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.

Scott DL, Ibrahim F, Farewell V, O'Keeffe AG, Walker D, Kelly C, Birrell F, Chakravarty K, Maddison P, Heslin M, Patel A, Kingsley GH - BMJ (2015)

Fig 2 Observed treatment differences for primary and secondary outcome measures in study in patients with rheumatoid arthritis randomised to treatment with combinations of disease modifying drugs or tumour necrosis factor inhibitors. Scales and direction of change for different outcome measures vary: health assessment questionnaire ranges from 0-3, higher scores are worse, and positive differences favour tumour necrosis factor strategy; EQ5D-3L ranges from 0-1, higher scores are better, and negative differences favour tumour necrosis factor strategy; SF-36 physical component score and mental component score range from 0-100, higher scores are better, and negative differences favours tumour necrosis factor strategy; Larsen score ranges from 0-200, higher scores are worse, and positive differences favours tumour necrosis factor strategy
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4358851&req=5

fig2: Fig 2 Observed treatment differences for primary and secondary outcome measures in study in patients with rheumatoid arthritis randomised to treatment with combinations of disease modifying drugs or tumour necrosis factor inhibitors. Scales and direction of change for different outcome measures vary: health assessment questionnaire ranges from 0-3, higher scores are worse, and positive differences favour tumour necrosis factor strategy; EQ5D-3L ranges from 0-1, higher scores are better, and negative differences favour tumour necrosis factor strategy; SF-36 physical component score and mental component score range from 0-100, higher scores are better, and negative differences favours tumour necrosis factor strategy; Larsen score ranges from 0-200, higher scores are worse, and positive differences favours tumour necrosis factor strategy
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).

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.

View Article: PubMed Central - PubMed

Affiliation: Department of Rheumatology, King's College London School of Medicine, London SE5 9RJ, UK d.scott1@nhs.net.

Show MeSH
Related in: MedlinePlus