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Characterising deviation from treat-to-target strategies for early rheumatoid arthritis: the first three years.

Wabe N, Sorich MJ, Wechalekar MD, Cleland LG, McWilliams L, Lee A, Spargo L, Metcalf RG, Hall C, Proudman SM, Wiese MD - Arthritis Res. Ther. (2015)

Bottom Line: However, successful implementation may be limited by deviations from the protocol.The prevalence of protocol deviations was lower among patients who achieved remission after three years (13.1%; 162 deviations out of 1,228 visits) compared with those who were not in remission (30.9%; 523/1692) (P<0.0001).Failure to escalate dose when indicated was commonly encountered, and just under half of the observed deviations were related to either toxicities or comorbidities and were therefore justifiable on clinical grounds.

View Article: PubMed Central - PubMed

Affiliation: School of Pharmacy and Medical Sciences and Sansom Institute for Health Research, University of South Australia, GPO Box 2471, Adelaide, 5001, Australia. nasir.wabe@unisa.edu.au.

ABSTRACT

Introduction: Treat-to-target (T2T) strategies using a protocol of pre-defined adjustments of disease-modifying anti-rheumatic drugs (DMARDs) according to disease activity improve outcomes for patients with rheumatoid arthritis (RA). However, successful implementation may be limited by deviations from the protocol. The aim of this study was to determine the prevalence of protocol deviation, explore the reasons and identify subsets of patients in whom treatment protocols are more difficult to follow.

Methods: In this retrospective cohort study, treatment-naïve patients with RA of less than one year's duration, attending a dedicated early arthritis clinic between 2001 and 2013, were followed for three years from initiation of combination therapy with conventional DMARDs which was subsequently modified according to a T2T protocol. At each clinic visit, whether deviation from the protocol occurred, the type of deviation and the reasons for deviation were assessed. The relationship between protocol deviations and baseline variables was determined using linear regression analysis.

Results: In total, 198 patients contributed 3,654 clinic visits. The prevalence of protocol deviations was 24.5% and deviation in at least at one clinic visit was experienced by 90.4% of patients. The median time to first deviation was 30 weeks. Continuing existing treatment rather than intensifying therapy was the most common type of deviation (59.9%). Patient and physician related factors were the most common reasons for deviation, each accounting for 24.7% of deviations, followed by toxicities (23.3%) and comorbidities (20.0%). The prevalence of protocol deviations was lower among patients who achieved remission after three years (13.1%; 162 deviations out of 1,228 visits) compared with those who were not in remission (30.9%; 523/1692) (P<0.0001). On multivariate analysis, only body mass index (P=0.003) and helplessness score (P=0.04) were independent predictors of protocol deviations although the predictive power of the model was not strong (R2=0.17).

Conclusions: Deviation from a T2T protocol occurred in one quarter of visits, indicating that applying the T2T approach is feasible in clinical practice. Failure to escalate dose when indicated was commonly encountered, and just under half of the observed deviations were related to either toxicities or comorbidities and were therefore justifiable on clinical grounds.

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Related in: MedlinePlus

Number and pattern of deviations and deviations according to dose modification criteria (DMC) and baseline disease activity. Percentage of patients versus number of deviations encountered (A) and pattern of deviations experienced (B). Mean (SD) percentage of visits with deviation per patient in each year of treatment (C) by criteria used to inform dose modification and (D) by baseline disease activity. LDA, low disease-activity; MDA, moderate disease-activity; DAS28, disease activity score in 28 joints.
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Fig1: Number and pattern of deviations and deviations according to dose modification criteria (DMC) and baseline disease activity. Percentage of patients versus number of deviations encountered (A) and pattern of deviations experienced (B). Mean (SD) percentage of visits with deviation per patient in each year of treatment (C) by criteria used to inform dose modification and (D) by baseline disease activity. LDA, low disease-activity; MDA, moderate disease-activity; DAS28, disease activity score in 28 joints.

Mentions: There was a total of 3,654 clinic visits over the follow-up period with a mean (SD) of 18.5 (6.0) visits per patient. The mean (SD) number of clinic visits per patient during the first, second and third years was 9.8 (2.0), 5.7 (2.2) and 4.9 (1.9), respectively. Deviation from the protocol occurred in 896 of 3,654 (24.5%) visits (median of 4.0 (2.0 to 7.0) per patient). Deviation in at least one clinic visit was experienced by 179 (90.4%) of the patients (Figure 1A). Temporary deviations (n = 35) and relapsing occasional deviation (n = 54) occurred in 44.9% (89 of 198) patients. The remainder of the patients experienced either persistent (n = 15, 7.6%) or recurrently persistent deviation (n = 75, 37.9%) (Figure 1B).Figure 1


Characterising deviation from treat-to-target strategies for early rheumatoid arthritis: the first three years.

Wabe N, Sorich MJ, Wechalekar MD, Cleland LG, McWilliams L, Lee A, Spargo L, Metcalf RG, Hall C, Proudman SM, Wiese MD - Arthritis Res. Ther. (2015)

Number and pattern of deviations and deviations according to dose modification criteria (DMC) and baseline disease activity. Percentage of patients versus number of deviations encountered (A) and pattern of deviations experienced (B). Mean (SD) percentage of visits with deviation per patient in each year of treatment (C) by criteria used to inform dose modification and (D) by baseline disease activity. LDA, low disease-activity; MDA, moderate disease-activity; DAS28, disease activity score in 28 joints.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4376505&req=5

Fig1: Number and pattern of deviations and deviations according to dose modification criteria (DMC) and baseline disease activity. Percentage of patients versus number of deviations encountered (A) and pattern of deviations experienced (B). Mean (SD) percentage of visits with deviation per patient in each year of treatment (C) by criteria used to inform dose modification and (D) by baseline disease activity. LDA, low disease-activity; MDA, moderate disease-activity; DAS28, disease activity score in 28 joints.
Mentions: There was a total of 3,654 clinic visits over the follow-up period with a mean (SD) of 18.5 (6.0) visits per patient. The mean (SD) number of clinic visits per patient during the first, second and third years was 9.8 (2.0), 5.7 (2.2) and 4.9 (1.9), respectively. Deviation from the protocol occurred in 896 of 3,654 (24.5%) visits (median of 4.0 (2.0 to 7.0) per patient). Deviation in at least one clinic visit was experienced by 179 (90.4%) of the patients (Figure 1A). Temporary deviations (n = 35) and relapsing occasional deviation (n = 54) occurred in 44.9% (89 of 198) patients. The remainder of the patients experienced either persistent (n = 15, 7.6%) or recurrently persistent deviation (n = 75, 37.9%) (Figure 1B).Figure 1

Bottom Line: However, successful implementation may be limited by deviations from the protocol.The prevalence of protocol deviations was lower among patients who achieved remission after three years (13.1%; 162 deviations out of 1,228 visits) compared with those who were not in remission (30.9%; 523/1692) (P<0.0001).Failure to escalate dose when indicated was commonly encountered, and just under half of the observed deviations were related to either toxicities or comorbidities and were therefore justifiable on clinical grounds.

View Article: PubMed Central - PubMed

Affiliation: School of Pharmacy and Medical Sciences and Sansom Institute for Health Research, University of South Australia, GPO Box 2471, Adelaide, 5001, Australia. nasir.wabe@unisa.edu.au.

ABSTRACT

Introduction: Treat-to-target (T2T) strategies using a protocol of pre-defined adjustments of disease-modifying anti-rheumatic drugs (DMARDs) according to disease activity improve outcomes for patients with rheumatoid arthritis (RA). However, successful implementation may be limited by deviations from the protocol. The aim of this study was to determine the prevalence of protocol deviation, explore the reasons and identify subsets of patients in whom treatment protocols are more difficult to follow.

Methods: In this retrospective cohort study, treatment-naïve patients with RA of less than one year's duration, attending a dedicated early arthritis clinic between 2001 and 2013, were followed for three years from initiation of combination therapy with conventional DMARDs which was subsequently modified according to a T2T protocol. At each clinic visit, whether deviation from the protocol occurred, the type of deviation and the reasons for deviation were assessed. The relationship between protocol deviations and baseline variables was determined using linear regression analysis.

Results: In total, 198 patients contributed 3,654 clinic visits. The prevalence of protocol deviations was 24.5% and deviation in at least at one clinic visit was experienced by 90.4% of patients. The median time to first deviation was 30 weeks. Continuing existing treatment rather than intensifying therapy was the most common type of deviation (59.9%). Patient and physician related factors were the most common reasons for deviation, each accounting for 24.7% of deviations, followed by toxicities (23.3%) and comorbidities (20.0%). The prevalence of protocol deviations was lower among patients who achieved remission after three years (13.1%; 162 deviations out of 1,228 visits) compared with those who were not in remission (30.9%; 523/1692) (P<0.0001). On multivariate analysis, only body mass index (P=0.003) and helplessness score (P=0.04) were independent predictors of protocol deviations although the predictive power of the model was not strong (R2=0.17).

Conclusions: Deviation from a T2T protocol occurred in one quarter of visits, indicating that applying the T2T approach is feasible in clinical practice. Failure to escalate dose when indicated was commonly encountered, and just under half of the observed deviations were related to either toxicities or comorbidities and were therefore justifiable on clinical grounds.

Show MeSH
Related in: MedlinePlus