Session Information
Date: Tuesday, October 23, 2018
Title: Spondyloarthritis Including Psoriatic Arthritis – Clinical Poster III: Treatment
Session Type: ACR Poster Session C
Session Time: 9:00AM-11:00AM
Background/Purpose:
Adalimumab (ADA) inhibited radiographic progression in patients (pts) with moderate to severe PsA in the ADEPT study and its open label extension (OLE). These post‑hoc analyses evaluated long-term inhibition of radiographic progression and impact on quality of life (QoL) in ADA treated pts with respect to the presence or absence of baseline (BL) radiographic damage.
Methods:
Pts who completed the ADEPT study (phase 3, double-blind, placebo [PBO] ‑controlled, 24‑week [wk] study in TNF inhibitor naive PsA pts) were eligible to enroll in the 120‑wk OLE with ADA 40 mg every other wk (eow). Only pts who continued into the OLE were included in these analyses of observed data. Radiographic damage at BL (BLrd) was defined as a modified Total Sharp Score (mTSS) >0.5; radiographic progression was defined as a change (Δ) from BL in mTSS by >0.5. Radiographic progression and changes in general health (SF-36), fatigue (FACIT‑F) and physical function (HAQ-DI) were evaluated until Wk 144 in pts grouped by presence or absence of BLrd and treatment (PBO/ADA or ADA/ADA in the ADEPT/OLE studies, respectively).
Results:
BLrd was observed in 81% (n=231/285) of the enrolled pts. At Wk 144, 49.8% (n=115/231) of those with BLrd and 51.9% (28/54) of those without BLrd, did not progress radiographically. Radiographic progression by Wk144 was significantly smaller in pts without than with BLrd (mean ΔmTSS from BL: 0.85 vs. 2.91, p<0.01). Further, in pts without BLrd who initially received ADA, fewer progressed (Wk 144: 12% vs. 24%), with significantly less mean radiographic progression up to Wk 144 (mean ΔmTSS from BL: 0.49 vs. 1.12, p<0.05). Mean radiographic progression through Wk 144 did not significantly differ between pts initially receiving ADA or PBO who had BLrd (mean ΔmTSS from BL: 3.41 vs. 2.43, NS). At Wk 144, there were no statistically significant differences in the mean changes from BL in HAQ-DI, FACIT-F, and SF-36 (PCS and MCS) in pts with or without BLrd (-0.40 vs. -0.33, 6.11 vs. 6.45, 7.50 vs. 7.98, and 2.88 vs. 3.44, NS). However, pts who received ADA compared with PBO exhibited significantly greater improvement in physical function (both SF-36 PCS and HAQ-DI, p<0.01) by wk 24 regardless of BLrd (Table).
Conclusion:
Moderate to severe PsA pts with BLrd experienced more long-term radiographic progression than those without. Interestingly, among pts without BLrd, initial treatment with ADA compared with PBO resulted in 50% fewer pts with radiographic progression and significantly lower mean radiographic progression through 144 weeks, whereas no long-term difference has been observed for physical function and QoL parameters.
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Table: Summary of change from baseline in the Quality of Life (QoL) parameters of SF-36, FACIT-F and HAQ-DI |
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Change from BL in SF-36 (PCS)† |
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With BL radiographic damage (N=231) |
Without BL radiographic damage (N=54) |
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|
Visits |
PBO/ADA |
ADA/ADA |
p value |
Visits |
PBO/ADA |
ADA/ADA |
p value |
|
Wk 24 |
1.94±9.6 |
8.64±9.1 |
<0.001 |
Wk 24 |
-0.49±8.7 |
11.42±11.9 |
<0.001 |
|
Wk 144 |
7.13±11.2 |
7.88±11.4 |
NS |
Wk 144 |
8.6±10.2 |
7.06±13.1 |
NS |
|
Change from BL in SF-36 (MCS)† |
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|
With BL radiographic damage (N=231) |
Without BL radiographic damage (N=54) |
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|
Visits |
PBO/ADA |
ADA/ADA |
p value |
Visits |
PBO/ADA |
ADA/ADA |
p value |
|
Wk 24 |
-0.29±11.2 |
2.26±9.8 |
NS |
Wk 24 |
1.86±9.1 |
0.87±7.9 |
NS |
|
Wk 144 |
3.43±11.5 |
2.32±10.7 |
NS |
Wk 144 |
4.77±10.7 |
1.57±8.6 |
NS |
|
Change from BL in FACIT-F†† |
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With BL radiographic damage (N=231) |
Without BL radiographic damage (N=54) |
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|
Visits |
PBO/ADA |
ADA/ADA |
p value |
Visits |
PBO/ADA |
ADA/ADA |
p value |
|
Wk 24 |
-0.08±10.1 |
7.08±9.6 |
<0.001 |
Wk 24 |
0.90±8.1 |
6.86±12.7 |
NS |
|
Wk 144 |
5.41±10.1 |
6.81±11.1 |
NS |
Wk 144 |
7.19±10.2 |
5.41±11.9 |
NS |
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Change from BL in HAQ-DI††† |
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|
With BL radiographic damage (N=231) |
Without BL radiographic damage (N=54) |
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|
Visits |
PBO/ADA |
ADA/ADA |
p value |
Visits |
PBO/ADA |
ADA/ADA |
p value |
|
Wk 24 |
-0.11±0.4 |
-0.41±0.5 |
<0.001 |
Wk 24 |
-0.04±0.4 |
-0.37±0.4 |
<0.01 |
|
Wk 144 |
-0.4±0.6 |
-0.40±0.5 |
NS |
Wk 144 |
-0.36±0.6 |
-0.29±0.4 |
NS |
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†higher SF-36 scores indicate better overall health; ††higher FACIT-F scores indicate lower fatigue; †††lower HAQ-DI scores indicate lower disability or better function. P values are from comparison of means between PBO/ADA and ADA/ADA using T‑test. ADA: originator adalimumab; BL: Baseline; FACIT-F: Functional Assessment of Chronic Illness Therapy-Fatigue scale; HAQ-DI: Health Assessment Questionnaire-Disability Index; MCS: Mental Component Summary; N: number of patients; PCS: Physical Component Summary; PBO: placebo; SF-36: Short Form Health Survey comprising of 36 questions; Wk: week |
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To cite this abstract in AMA style:
Coates LC, Mease PJ, Chen K, Hojnik M, Valdecantos W, Sheth P, Aletaha D, Ganz F. Long-Term Inhibition of Radiographic Progression with Originator Adalimumab in Patients with Moderate to Severe Psoriatic Arthritis with or without Radiographic Damage at Baseline [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/long-term-inhibition-of-radiographic-progression-with-originator-adalimumab-in-patients-with-moderate-to-severe-psoriatic-arthritis-with-or-without-radiographic-damage-at-baseline/. Accessed .« Back to 2018 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/long-term-inhibition-of-radiographic-progression-with-originator-adalimumab-in-patients-with-moderate-to-severe-psoriatic-arthritis-with-or-without-radiographic-damage-at-baseline/