Session Information
Date: Monday, November 9, 2015
Title: Quality Measures and Quality of Care Poster Session (ARHP): Clinical Practice/Patient Care
Session Type: ACR Poster Session B
Session Time: 9:00AM-11:00AM
Background/Purpose: While the introduction of the treat-to-target (T2T) strategy is associated with lower disease activity scores in rheumatoid arthritis (RA), the potential for increased toxicity due to more intensive use of concurrent DMARDs could adversely affect patient reported outcomes (PROs). The objective was to determine the effects of DMARD related toxicity on PROs in early RA patients treated according to T2T strategy for 3 years
Methods: A total of 149 patients from an inception cohort of recent onset RA were included. The occurrence and severity of toxicity were monitored at each clinic visit over three years. PROs studied were function (measured using health assessment questionnaire), helplessness (assessed using the rheumatology attitudes index), pain, fatigue and patient global assessment (PGA) all assessed using a 100mm visual analogue scale and health-related quality of life (HRQoL) (assessed using SF-36).
For each PRO, the effect of drug withdrawal was measured by comparing mean change from baseline among patients with no/temporary withdrawal versus those with permanent drug cessation. The effects of the frequency of minor side effects, frequency of drug withdrawals, weeks to withdrawal and number of drugs withdrawn were analysed using linear regression.
Results: After 3 years, 56 (37.6%) patients ceased at least one drug permanently due to toxicity. Patients with no/temporary withdrawal (n=93) achieved significantly greater improvement in function, pain, fatigue and PGA compared to their counterparts (n=56). Drug-related toxicity did not have a significant effect on HRQoL and helplessness (Table 1).
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Table 1: Improvement in PROs, mean change (SE), according to withdrawal due to toxicity |
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|
|
No/temporary withdrawal (n=93) |
Permanent withdrawal (n=56) |
Between group mean differences (95%CI) |
P-value |
|
Function |
-0.54 (0.06) |
-0.31 (0.09) |
-0.23 (-0.44 to -0.02) |
0.033 |
|
Pain |
-39.82 (3.44) |
-25.02 (5.50) |
-14.80 (-27.03 to -2.56) |
0.018 |
|
Fatigue |
-29.14 (3.43) |
-14.76 (4.89) |
-14.38 (-25.97 to -2.80) |
0.015 |
|
PGA |
-29.64 (3.16) |
-17.00 (4.21) |
-12.64 (-23.03 to -2.25) |
0.018 |
|
Helplessness |
-4.44 (0.62) |
-3.69 (0.75) |
-0.75 (-2.73 to 1.23) |
0.455 |
|
SF-36 Summary |
|
|
|
|
|
Physical |
10.85 (1.32) |
6.84 (1.78) |
4.01 (-0.36 to 8.38) |
0.072 |
|
Mental |
4.31 (1.38) |
4.48 (1.83) |
-0.17 (-4.71 to 4.37) |
0.941 |
After adjusting for other relevant baseline variables, regression analysis indicated that higher frequency of withdrawals was associated with lesser improvements in function, pain, fatigue and PGA, while the number of drugs withdrawn and the time to withdrawal had lesser effects. The occurrence of minor side effects did not affect change in PROs (Table 2).
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Table 2: Relationship between drug-related toxicities and improvement in PROs over 3 years. |
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|
Nature of toxicity |
Function |
Pain |
Fatigue |
PGA |
Helplessness |
SF-36 Physical |
SF-36 Mental |
|
|
Frequency of minor side effects |
β |
-0.02 |
-1.34 |
0.14 |
-0.98 |
-0.04 |
-0.13 |
-0.21 |
|
SE |
0.01 |
0.71 |
0.75 |
0.62 |
0.11 |
0.28 |
0.29 |
|
|
P-value |
0.262 |
0.061 |
0.854 |
0.119 |
0.701 |
0.630 |
0.474 |
|
|
Frequency of withdrawals |
β |
-0.07 |
-4.17 |
-3.47 |
-4.12 |
-0.34 |
-1.04 |
-0.32 |
|
SE |
0.03 |
1.32 |
1.38 |
1.13 |
0.22 |
0.52 |
0.56 |
|
|
P-value |
0.005 |
0.002 |
0.013 |
<0.000 |
0.124 |
0.05 |
0.573 |
|
|
Weeks to first withdrawal |
β |
0.003 |
0.21 |
0.17 |
0.19 |
0.0 |
0.07 |
0.05 |
|
SE |
0.002 |
0.11 |
0.10 |
0.09 |
0.02 |
0.04 |
0.04 |
|
|
P-value |
0.092 |
0.065 |
0.118 |
0.039 |
0.979 |
0.101 |
0.246 |
|
|
No. of drugs withdrawn |
β |
-0.06 |
-4.29 |
-3.31 |
-4.15 |
-0.39 |
-0.32 |
-0.52 |
|
SE |
0.03 |
1.86 |
1.87 |
1.56 |
0.29 |
0.69 |
0.73 |
|
|
P-value |
0.091 |
0.023 |
0.080 |
0.009 |
0.183 |
0.649 |
0.481 |
|
|
The Beta sign indicates whether the PROs improved or not as a result of drug-induced toxicity. Negative scores indicate inverse relationship while positive scores indicate direct relationship. |
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Conclusion: In the setting of a T2T strategy where use of multiple DMARDs and frequent dose escalation were common, DMARD withdrawal due to toxicity was significantly associated with less improvement in function, pain, fatigue and PGA while toxicity had little impact on helplessness and broader measures of HRQoL.
To cite this abstract in AMA style:
Wabe N, Sorich M, Wechalekar M, Cleland L, McWilliams L, Lee A, Spargo L, Metcalf R, Hall C, Proudman S, Wiese MD. Effects of Drug Induced Toxicity on Patient Reported Outcomes in Early Rheumatoid Arthritis Treated-to-Target Using Conventional Triple DMARD Therapy [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/effects-of-drug-induced-toxicity-on-patient-reported-outcomes-in-early-rheumatoid-arthritis-treated-to-target-using-conventional-triple-dmard-therapy/. Accessed .« Back to 2015 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/effects-of-drug-induced-toxicity-on-patient-reported-outcomes-in-early-rheumatoid-arthritis-treated-to-target-using-conventional-triple-dmard-therapy/