Session Type: ACR Poster Session A
Session Time: 9:00AM-11:00AM
Background/Purpose: Previous analyses in patients (pts) with rheumatoid arthritis (RA) have evaluated the relationship between controlling disease activity and achieving long-term improvements in health-related quality of life (HRQoL) using the DAS28 or ACR20 to assess clinical response. However, the clinical disease activity index (CDAI) is more commonly used among community practicing rheumatologists. This analysis examined the predictive value of achieving low disease activity (CDAI≤10) and normalization of long-term HRQoL.
Methods: In the phase 3 GO-FURTHER trial, 592 pts with active RA despite MTX therapy were randomized (2:1) to IV golimumab (GLM) 2mg/kg+MTX or placebo (PBO)+MTX at wks 0 and 4, then q8w; PBO pts crossed over to GLM at wk16 (early escape) or wk24 (crossover). In this post-hoc analysis, disease activity was measured using the CDAI, and HRQoL was assessed using patient-reported outcomes: FACIT-Fatigue, HAQ-DI, and SF-36 physical/mental component summary (PCS/MCS) scores and individual domain scores. Normalization of HRQoL (based on the means for the general population) was defined as follows: FACIT-Fatigue ≥43.6, HAQ-DI ≤0.5, and SF-36 PCS/MCS and domain scores ≥50. Logistic regression analyses (adjusted for gender, age, current smoking status, and baseline CDAI score and PRO assessments) were performed to evaluate the relationship between achieving low disease activity (CDAI ≤10) and normalization of HRQoL at each time point through 2 years. Additionally, the predictive value of achieving CDAI≤10 at wk12 and wk24 and normalization of HRQoL at 1 year and 2 years was also assessed.
Results: Greater proportions of pts in the IV GLM 2mg/kg+MTX group achieved CDAI ≤10 compared with the PBO+MTX group at wk12 (19.6% vs 9.8%; p=0.0026) and wk24 (38.2% vs 18.5%; p<0.0001) (PBO-controlled period). Achieving a CDAI ≤ 10 was strongly associated with normalized HAQ-DI, FACIT-Fatigue, SF-36 PCS/MCS scores and SF-36 domain scores at each time point through 2 years (p<0.0001 for most variables). Pts who achieved CDAI ≤10 at wk12 or wk24 were more likely to achieve normalized HAQ-DI, FACIT-Fatigue, SF-36 PCS/MCS scores, and SF-36 domain scores at 1 year than were pts with CDAI >10 (Odds ratio [OR] range: 1.8-5.9 and 1.7-6.6, respectively). Similar results were observed for pts with CDAI ≤10 at wk12 or wk24 and normalized HRQoL at 2 years (OR range: 2.2-4.6 and 2.0-3.7, respectively).
Conclusion: Greater proportions of GLM+MTX pts achieved CDAI ≤10 at wks 12 and 24 compared with PBO+MTX. Achieving low disease activity (CDAI ≤10) at either wk12 or wk24 was predictive of achieving normalized HAQ-DI, FACIT-Fatigue, SF-36 PCS/MCS scores, and SF-36 component scores at 1 year and 2 years in pts with active RA.
To cite this abstract in AMA style:Bingham CO III, Weinblatt M, Westhovens R, Kim L, Han C, Xu S, Lo KH, Tang KL, Hsia EC, Parenti D, Kafka S. Low Disease Activity at 12 Weeks and 24 Weeks Is Predictive of Normalized Health-Related Quality of Life in Methotrexate-Experienced Patients with Active Rheumatoid Arthritis Treated with Intravenous Golimumab Plus Methotrexate [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/low-disease-activity-at-12-weeks-and-24-weeks-is-predictive-of-normalized-health-related-quality-of-life-in-methotrexate-experienced-patients-with-active-rheumatoid-arthritis-treated-with-intravenous/. Accessed February 25, 2020.
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/low-disease-activity-at-12-weeks-and-24-weeks-is-predictive-of-normalized-health-related-quality-of-life-in-methotrexate-experienced-patients-with-active-rheumatoid-arthritis-treated-with-intravenous/