Session Information
Date: Tuesday, October 23, 2018
Title: 5T112 ACR Abstract: Spondyloarthritis Incl PsA–Clinical V: Tx of PsA & Peripheral SpA (2886–2891)
Session Type: ACR Concurrent Abstract Session
Session Time: 4:30PM-6:00PM
Background/Purpose: GO-VIBRANT is a Phase 3 trial of intravenous (IV) golimumab (GLM), an anti-tumor necrosis factor alpha (TNFα) monoclonal antibody, in adult patients (pts) w/ active psoriatic arthritis (PsA). To assess whether changes in Clinical Disease Activity Index (CDAI), Disease Activity in Psoriatic Arthritis (DAPSA) score, Minimal Disease Activity (MDA), & Very Low Disease Activity (VLDA) disease activity measures correlate w/ X-ray progression.
Methods: In this multicenter, randomized, double-blind, placebo (PBO)-controlled trial, 480-bionaïve PsA pts w/ active disease (≥5 swollen & ≥5 tender joints, C-reactive protein ≥0.6mg/dL, active plaque psoriasis or documented history, & despite treatment w/ csDMARDs &/or NSAIDs) received IV GLM 2 mg/kg (N=241) at Wks 0 & 4 then q8 wks or PBO (N=239) at Wks 0, 4, 12, & 20 w/ crossover to GLM at Wk24. In this post-hoc analysis, disease activity measures CDAI, DAPSA score, MDA, & VLDA were associated w/ X-ray progression from baseline to Wk24 & baseline to Wk52. Total modified van der Heijde-Sharp (vdH-S) score was used to assess X-rays at Wks 0, 24, & 52. Imputation rules were applied for all variables using last observation carried forward for partially missing data & non-responder imputation for completely missing data.
Results: Changes in all disease activity measures appeared to be correlated w/ X-ray progression (Table). GLM-treated pts had less X-ray progression regardless of disease activity measure used. GLM‑treated pts in remission or in low disease activity (LDA) tended to have less X-ray progression at Wk52 vs pts in moderate or high disease activity categories (mean change in CDAI: remission -1.06, low activity -0.81, moderate activity 0.20, high activity 1.11). Irrespective of level of disease activity, GLM-treated pts from Wk0-52 tended to have less X-ray progression vs PBO-treated pts who switched to GLM at Wk24 (mean change in CDAI 0-52 wk GLM vs PBO: remission -1.06 vs 1.52, low activity -0.81 vs 1.21, moderate activity 0.20 vs 1.32, high activity 1.11 vs 1.75). GLM-treated pts w/ DAPSA scores £28 at Wk0-52 tended to have less X-ray progression (mean change ‑0.74) vs pts w/ scores >28 (mean change 0.41). Pts treated w/ GLM who despite not achieving MDA or VLDA by Wk52 also tended to have far less X-ray progression vs PBO pts (mean change MDA PBO 1.50 vs GLM 0.03; p< 0.0011 & mean change VLDA PBO 1.45 vs. -0.30; p<0.0001).
Conclusion: In this analysis, all disease activity measures generally correlated w/ X-ray progression from baseline to Wk24 & baseline to Wk52. Higher disease activity was associated w/ increased X-ray progression. GLM‑treated pts not achieving MDA & VLDA at Wk52 tended to have less X-ray progression vs PBOàGLM pts. GLM’s ability to inhibit X-ray progression, despite pts not being in clinical remission or LDA, illustrates an example of “disconnect” between clinical outcomes & X-ray findings seen in other studies.
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Table. Mean change from baseline (SD) in total modified vdH-S score stratified by CDAI, DAPSA, MDA, & VLDA in PsA pts from GO-VIBRANT |
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Baseline to Wk24 |
Baseline to Wk52 |
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PBO |
GLM 2 mg/kg |
PBOa |
GLM 2 mg/kg |
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CDAI at Wk24 or Wk52 |
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Remission (£2.8), n Mean change (SD) Median Range p-valueb |
5 -0.60±1.34 0 -3.00, 0.00 |
43 -0.80±1.76 -0.50 -5.00, 2.00 0.9170 |
58 1.52±5.55 0 -6.50, 33.23 |
63 -1.06±2.41 0 -8.50, 6.00 0.0003 |
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Low disease activity (>2.8 & £10), n Mean change (SD) Median Range p-value |
28 0.77±2.01 0.50 -4.50, 5.50 |
98 -0.41±1.43 0 -5.00, 2.50 0.0011 |
78 1.21±3.59 0 -7.00, 15.50 |
92 -0.81±2.12 0 -7.90, 3.00 <0.0001 |
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Moderate disease activity (>10 & £22), n Mean change (SD) Median Range p-value |
67 0.88±2.73 0 -4.50, 12.92 |
66 -0.10±2.04 0 -7.50, 7.50 0.0429 |
64 1.32±4.25 0 -5.77, 21.71 |
69 0.20±2.82 0 -7.29, 15.96 0.0905 |
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High disease activity (>22), n Mean change (SD) Median Range p-value |
137 1.96±3.79 0.50 -3.50, 19.00 |
30 0.30±1.95 0 -3.50, 8.00 0.0079 |
37 1.75±5.34 0 -1.50, 29.61 |
13 1.11±2.65 0 -2.50, 7.50 0.8144 |
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DAPSA at Wk24 or Wk52 |
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£28, n Mean change (SD) Median Range p-value |
47 0.22±1.87 0 -4.50, 5.50
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166 -0.53±1.62 0 -5.50, 3.36 0.0046 |
171 1.45±4.66 0 -7.00, 33.23 |
183 -0.74±2.17 0 -8.50, 6.00 <0.0001 |
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>28, n Mean change (SD) Median Range p-value |
190 1.77±3.56 0.50 -3.50, 19.00 |
71 0.21±1.97 0 -7.50, 8.00 0.0007 |
66 1.27±4.36 0 -3.50, 29.61 |
54 0.41±3.30 0 -7.29, 15.96 0.2598 |
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MDA at Wk24 or Wk52 |
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Yes, n Mean change (SD) Median Range p-value |
11 0.91±2.49 0 -3.00, 5.50 |
78 -0.83±1.78 0 -7.50, 1.50 0.0232 |
80 1.19±3.86 0 -7.00, 16.65 |
101 -1.16±2.46 0 -8.50, 6.00 <0.0001 |
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No, n Mean change (SD) Median Range p-value |
226 1.49±3.39 0.50 -4.50, 19.00 |
159 -0.05±1.70 0 -5.00, 8.00 <0.0001 |
157 1.50±4.90 0 -5.77, 33.23 |
136 0.03±2.44 0 -7.29, 15.96 0.0011 |
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VLDA at Wk24 or Wk52 |
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Yes, n Mean change (SD) Median Range p-value |
1 0±NA 0 0.00, 0.00 |
16 -0.91±1.04 -1.00 -3.00, 1.00 0.3749 |
24 0.91±3.32 0 -4.00, 8.76
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35 -1.49±2.22 -0.50 -8.00, 1.50 0.0041 |
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No, n Mean change (SD) Median Range p-value |
236 1.47±3.36 0.50 -4.50, 19.00 |
221 -0.26±1.80 0 -7.50, 8.00 <0.0001 |
213 1.45±4.69 0 -7.00, 33.23 |
202 -0.30±2.52 0 -8.50, 15.96 <0.0001 |
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CDAI=Clinical Disease Activity Index; DAPSA=Disease Activity in Psoriatic Arthritis score; GLM=golimumab; MDA=Minimal Disease Activity; NA=not available; PBO=placebo; PsA=active psoriatic arthritis; SD=st&ard deviation; VLDA=Very Low Disease Activity aPBO pts crossed over to IV GLM at Wk24. bP-value is based on ANOVA w/ Van der Waerden rank test |
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To cite this abstract in AMA style:
Mease PJ, Kafka S, Chakravarty SD, Harrison DD, Lo KH, Xu S, Hsia EC, Kavanaugh A. Inhibition of Radiographic Progression and Correlation with Changes in Composite Indices of Disease Activity in Patients with Active Psoriatic Arthritis Treated with Intravenous Golimumab, As Measured in a Phase III Trial [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/inhibition-of-radiographic-progression-and-correlation-with-changes-in-composite-indices-of-disease-activity-in-patients-with-active-psoriatic-arthritis-treated-with-intravenous-golimumab-as-measured/. Accessed .« Back to 2018 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/inhibition-of-radiographic-progression-and-correlation-with-changes-in-composite-indices-of-disease-activity-in-patients-with-active-psoriatic-arthritis-treated-with-intravenous-golimumab-as-measured/