The clinical effectiveness of intensive management in moderate established rheumatoid arthritis: The titrate trial

David Scott; Fowzia Ibrahim; Harry Hill; Brian Tom; Louise Prothero; Rhiannon R. Baggott; Ailsa Bosworth; James B. Galloway; Sofia Georgopoulou; Naomi Martin; Isabel Neatrour; Elena Nikiphorou; Jackie Sturt; Allan Wailoo; Frances MK Williams; Ruth Williams; Heidi Lempp

doi:10.1016/j.semarthrit.2020.07.014

The clinical effectiveness of intensive management in moderate established rheumatoid arthritis: The titrate trial

David Scott, Fowzia Ibrahim^*, Harry Hill, Brian Tom, Louise Prothero, Rhiannon R. Baggott, Ailsa Bosworth, James B. Galloway, Sofia Georgopoulou, Naomi Martin, Isabel Neatrour, Elena Nikiphorou, Jackie Sturt, Allan Wailoo, Frances MK Williams, Ruth Williams, Heidi Lempp

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

10 Citations (Scopus)

Abstract

Objectives: Many trials have shown that intensive management is effective in patients with early active rheumatoid arthritis (RA). But its benefits are unproven for the large number of RA patients seen in routine care who have established, moderately active RA and are already taking conventional synthetic disease modifying anti-rheumatic drugs (csDMARDs). The TITRATE trial studied whether these patients also benefit from intensive management and, in particular, achieve more remissions. Methods: A 12-month multicentre individually randomised trial compared standard care with monthly intensive management appointments which was delivered by specially trained healthcare professionals and incorporated monthly clinical assessments, medication titration and psychosocial support. The primary outcome was 12-month remission assessed using the Disease Activity Score for 28 joints using ESR (DAS28-ESR). Secondary outcomes included fatigue, disability, harms and healthcare costs. Intention-to-treat multivariable logistic- and linear regression analyses compared treatment arms with multiple imputation used for missing data. Results: 459 patients were screened and 335 were randomised (168 intensive management; 167 standard care); 303 (90%) patients provided 12-month outcomes. Intensive management increased DAS28-ESR 12-month remissions compared to standard care (32% vs 18%, p = 0.004). Intensive management also significantly increased remissions using a range of alternative remission criteria and increased patients with DAS28-ESR low disease activity scores. (48% vs 32%, p = 0.005). In addition it substantially reduced fatigue (mean difference -18; 95% CI: -24, -11, p<0.001). There was no evidence that serious adverse events (intensive management =15 vs standard care =11) or other adverse events (114 vs 151) significantly increase with intensive management. Interpretation: The trial shows that intensive management incorporating psychosocial support delivered by specially trained healthcare professions is effective in moderately active established RA. More patients achieve remissions, there were greater improvements in fatigue, and there were no more harms.

Original language	English
Pages (from-to)	1182-1190
Number of pages	9
Journal	Seminars in Arthritis and Rheumatism
Volume	50
Issue number	5
Early online date	30 Jul 2020
DOIs	https://doi.org/10.1016/j.semarthrit.2020.07.014
Publication status	Published - Oct 2020

Keywords

Anti-rheumatic agents
Clinical trial
Intensive management
Person-centred care
Psychosocial support
Rheumatoid arthritis

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10.1016/j.semarthrit.2020.07.014

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Scott, D., Ibrahim, F., Hill, H., Tom, B., Prothero, L., Baggott, R. R., Bosworth, A., Galloway, J. B., Georgopoulou, S., Martin, N., Neatrour, I., Nikiphorou, E., Sturt, J., Wailoo, A., Williams, F. MK., Williams, R., & Lempp, H. (2020). The clinical effectiveness of intensive management in moderate established rheumatoid arthritis: The titrate trial. Seminars in Arthritis and Rheumatism, 50(5), 1182-1190. https://doi.org/10.1016/j.semarthrit.2020.07.014

@article{69e96dfab06a434c952ce714a7928c23,

title = "The clinical effectiveness of intensive management in moderate established rheumatoid arthritis: The titrate trial",

abstract = "Objectives: Many trials have shown that intensive management is effective in patients with early active rheumatoid arthritis (RA). But its benefits are unproven for the large number of RA patients seen in routine care who have established, moderately active RA and are already taking conventional synthetic disease modifying anti-rheumatic drugs (csDMARDs). The TITRATE trial studied whether these patients also benefit from intensive management and, in particular, achieve more remissions. Methods: A 12-month multicentre individually randomised trial compared standard care with monthly intensive management appointments which was delivered by specially trained healthcare professionals and incorporated monthly clinical assessments, medication titration and psychosocial support. The primary outcome was 12-month remission assessed using the Disease Activity Score for 28 joints using ESR (DAS28-ESR). Secondary outcomes included fatigue, disability, harms and healthcare costs. Intention-to-treat multivariable logistic- and linear regression analyses compared treatment arms with multiple imputation used for missing data. Results: 459 patients were screened and 335 were randomised (168 intensive management; 167 standard care); 303 (90%) patients provided 12-month outcomes. Intensive management increased DAS28-ESR 12-month remissions compared to standard care (32% vs 18%, p = 0.004). Intensive management also significantly increased remissions using a range of alternative remission criteria and increased patients with DAS28-ESR low disease activity scores. (48% vs 32%, p = 0.005). In addition it substantially reduced fatigue (mean difference -18; 95% CI: -24, -11, p<0.001). There was no evidence that serious adverse events (intensive management =15 vs standard care =11) or other adverse events (114 vs 151) significantly increase with intensive management. Interpretation: The trial shows that intensive management incorporating psychosocial support delivered by specially trained healthcare professions is effective in moderately active established RA. More patients achieve remissions, there were greater improvements in fatigue, and there were no more harms.",

keywords = "Anti-rheumatic agents, Clinical trial, Intensive management, Person-centred care, Psychosocial support, Rheumatoid arthritis",

author = "David Scott and Fowzia Ibrahim and Harry Hill and Brian Tom and Louise Prothero and Baggott, {Rhiannon R.} and Ailsa Bosworth and Galloway, {James B.} and Sofia Georgopoulou and Naomi Martin and Isabel Neatrour and Elena Nikiphorou and Jackie Sturt and Allan Wailoo and Williams, {Frances MK} and Ruth Williams and Heidi Lempp",

year = "2020",

month = oct,

doi = "10.1016/j.semarthrit.2020.07.014",

language = "English",

volume = "50",

pages = "1182--1190",

journal = "Seminars in Arthritis and Rheumatism",

issn = "0049-0172",

publisher = "W.B. Saunders Ltd",

number = "5",

}

Scott, D , Ibrahim, F, Hill, H, Tom, B, Prothero, L , Baggott, RR, Bosworth, A, Galloway, JB , Georgopoulou, S , Martin, N , Neatrour, I , Nikiphorou, E , Sturt, J, Wailoo, A, Williams, FMK , Williams, R & Lempp, H 2020, 'The clinical effectiveness of intensive management in moderate established rheumatoid arthritis: The titrate trial', Seminars in Arthritis and Rheumatism, vol. 50, no. 5, pp. 1182-1190. https://doi.org/10.1016/j.semarthrit.2020.07.014

TY - JOUR

T1 - The clinical effectiveness of intensive management in moderate established rheumatoid arthritis

T2 - The titrate trial

AU - Scott, David

AU - Ibrahim, Fowzia

AU - Hill, Harry

AU - Tom, Brian

AU - Prothero, Louise

AU - Baggott, Rhiannon R.

AU - Bosworth, Ailsa

AU - Galloway, James B.

AU - Georgopoulou, Sofia

AU - Martin, Naomi

AU - Neatrour, Isabel

AU - Nikiphorou, Elena

AU - Sturt, Jackie

AU - Wailoo, Allan

AU - Williams, Frances MK

AU - Williams, Ruth

AU - Lempp, Heidi

PY - 2020/10

Y1 - 2020/10

N2 - Objectives: Many trials have shown that intensive management is effective in patients with early active rheumatoid arthritis (RA). But its benefits are unproven for the large number of RA patients seen in routine care who have established, moderately active RA and are already taking conventional synthetic disease modifying anti-rheumatic drugs (csDMARDs). The TITRATE trial studied whether these patients also benefit from intensive management and, in particular, achieve more remissions. Methods: A 12-month multicentre individually randomised trial compared standard care with monthly intensive management appointments which was delivered by specially trained healthcare professionals and incorporated monthly clinical assessments, medication titration and psychosocial support. The primary outcome was 12-month remission assessed using the Disease Activity Score for 28 joints using ESR (DAS28-ESR). Secondary outcomes included fatigue, disability, harms and healthcare costs. Intention-to-treat multivariable logistic- and linear regression analyses compared treatment arms with multiple imputation used for missing data. Results: 459 patients were screened and 335 were randomised (168 intensive management; 167 standard care); 303 (90%) patients provided 12-month outcomes. Intensive management increased DAS28-ESR 12-month remissions compared to standard care (32% vs 18%, p = 0.004). Intensive management also significantly increased remissions using a range of alternative remission criteria and increased patients with DAS28-ESR low disease activity scores. (48% vs 32%, p = 0.005). In addition it substantially reduced fatigue (mean difference -18; 95% CI: -24, -11, p<0.001). There was no evidence that serious adverse events (intensive management =15 vs standard care =11) or other adverse events (114 vs 151) significantly increase with intensive management. Interpretation: The trial shows that intensive management incorporating psychosocial support delivered by specially trained healthcare professions is effective in moderately active established RA. More patients achieve remissions, there were greater improvements in fatigue, and there were no more harms.

AB - Objectives: Many trials have shown that intensive management is effective in patients with early active rheumatoid arthritis (RA). But its benefits are unproven for the large number of RA patients seen in routine care who have established, moderately active RA and are already taking conventional synthetic disease modifying anti-rheumatic drugs (csDMARDs). The TITRATE trial studied whether these patients also benefit from intensive management and, in particular, achieve more remissions. Methods: A 12-month multicentre individually randomised trial compared standard care with monthly intensive management appointments which was delivered by specially trained healthcare professionals and incorporated monthly clinical assessments, medication titration and psychosocial support. The primary outcome was 12-month remission assessed using the Disease Activity Score for 28 joints using ESR (DAS28-ESR). Secondary outcomes included fatigue, disability, harms and healthcare costs. Intention-to-treat multivariable logistic- and linear regression analyses compared treatment arms with multiple imputation used for missing data. Results: 459 patients were screened and 335 were randomised (168 intensive management; 167 standard care); 303 (90%) patients provided 12-month outcomes. Intensive management increased DAS28-ESR 12-month remissions compared to standard care (32% vs 18%, p = 0.004). Intensive management also significantly increased remissions using a range of alternative remission criteria and increased patients with DAS28-ESR low disease activity scores. (48% vs 32%, p = 0.005). In addition it substantially reduced fatigue (mean difference -18; 95% CI: -24, -11, p<0.001). There was no evidence that serious adverse events (intensive management =15 vs standard care =11) or other adverse events (114 vs 151) significantly increase with intensive management. Interpretation: The trial shows that intensive management incorporating psychosocial support delivered by specially trained healthcare professions is effective in moderately active established RA. More patients achieve remissions, there were greater improvements in fatigue, and there were no more harms.

KW - Anti-rheumatic agents

KW - Clinical trial

KW - Intensive management

KW - Person-centred care

KW - Psychosocial support

KW - Rheumatoid arthritis

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U2 - 10.1016/j.semarthrit.2020.07.014

DO - 10.1016/j.semarthrit.2020.07.014

M3 - Article

AN - SCOPUS:85090554652

SN - 0049-0172

VL - 50

SP - 1182

EP - 1190

JO - Seminars in Arthritis and Rheumatism

JF - Seminars in Arthritis and Rheumatism

IS - 5

ER -

The clinical effectiveness of intensive management in moderate established rheumatoid arthritis: The titrate trial

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