Session Information
Title: Spondylarthropathies and Psoriatic Arthritis - Clinical Aspects and Treatment: Psoriatic Arthritis
Session Type: Abstract Submissions (ACR)
Background/Purpose: Although TNF-inhibitors (TNFi) have proven efficacy in psoriatic arthritis (PsA), some patients do not respond to or do not tolerate their first TNFi. The efficacy of a second TNFi in this group is not well established. Our objective was to investigate the efficacy of switching to a second TNFi in PsA patients.
Methods: Patients were selected from NOR-DMARD – a longitudinal observational study (LOS) in which patients with inflammatory arthropathies are included when starting a new disease-modifying anti-rheumatic drug (DMARD). Patients with PsA receiving their 1st TNFi were selected, and among these patients a subgroup who later switched to a 2nd TNFi was identified (switchers). Three-month response and one year drug-survival were assessed for non-switchers and for the 1st and 2nd TNFi of the switchers. Selected outcome measures were ACR20/50/70 and EULAR responses, DAS28 remission and low disease activity rates, patient and physician global, MHAQ and SF6D. Both state and change from baseline were assessed, and compared statistically between switchers and non-switchers using Chi2 and independent t-tests. Drug survival was compared by log-rank test. The overall response and drug survival to the first TNFi (switchers + non-switchers) was also assessed.
Results: Baseline characteristics are shown in table 1. There were no significant differences between switchers and non-switchers at baseline. There were significant differences in response between non-switchers and switchers receiving their 1st TNFi for several outcome measures, and these differences were more pronounced for the 2nd TNFi of the switchers with highly significant p-values for most outcome measures (table 2).One-year drug survival for the 2nd TNFi in switchers and non-switchers was 0.56 vs. 0.83 (p-value<0.001).
The overall ACR 20/50/70 responses for the 1st TNFi (n=439) were 59.9/37.8/29.6%, and the estimated 1-year drug survival was 0.74 – hence clearly superior to the 2nd TNFi (table 2).
There was no difference in response to second TNFi when comparing those who discontinued due to lack of efficacy (n=45) to those who discontinued due to adverse events (n=33).
Conclusion: Among patients with PsA who switched to a second TNFi after having failed their first TNFi, less than half achieved a clinical response at 3 months in this LOS. This observation highlights the need for treatments for PsA with other mechanisms of action.
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Table 1: Baseline characteristics
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Non-switchers N=344 |
Switchers
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1st TNFi (N=95) |
2nd TNFi (N=95) |
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Age
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46.8 (11.7) |
46.1 (11.6) |
47.7 (11.5) |
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Males sex (%)
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55.2 |
48.4 |
48.4 |
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Type of TNFi (%)
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Etanercept
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49.4 |
52.6 |
32.6 |
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Infliximab
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10.5 |
13.7 |
16.8 |
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Adalimumab
|
29.1 |
29.5 |
36.8 |
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Golimumab
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10.5 |
4.2 |
11.6 |
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Certolizumab
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0.6 |
0 |
2.1 |
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Co-Medication (%)
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62.3 |
54.8 |
51.7 |
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Disease duration (yrs)
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6.0 (1.5-12.4) |
4.7 (1.3-13.8) |
6.5 (2.7-14.2) |
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Current smoker (%)
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29.9 |
30.9 |
32.6 |
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Previous DMARDs
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1.5 (1.1) |
1.7 (1.1) |
1.7 (1.1) |
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CRP (median(IQR))
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9 (5-20) |
8 (4.27) |
5 (2-19) |
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Swollen joints (median(IQR))
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3 (1-6) |
3 (1-6) |
2 (0-4) |
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DAS28
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4.1 (1.3) |
4.4 (1.3) |
4.2 (1.5) |
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Physician global
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36.5 (17.5) |
39.5 (18.4) |
34.7 (18.6) |
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Patient global
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53.2 (22.9) |
57.4 (21.2) |
55.3 (22.7) |
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MHAQ score
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0.68 (0.45) |
0.77 (0.47) |
0.74 (0.48) |
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SF6D
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0.59 (0.12) |
0.58 (0.11) |
0.59(0.13)
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Mean (SD) unless otherwise indicated. VAS (0-100), MHAQ = Modified health assessment questionnaire (0-3), SF-6D = Short form -6 dimensions (0-1). |
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Table 2: 3-month response
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Non-switchers N=259
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Switchers
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P-value
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1st TNFi N=74
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2nd TNFi N=63
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Non-switcher vs. 1st TNFi (switchers)
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Non-switchers vs. 2nd TNFi (switchers)
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ACR20 (%)
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63.0 |
49.3 |
40.7 |
0.05 |
0.003 |
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ACR50 (%)
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40.0 |
30.4 |
24.1 |
0.16 |
0.03 |
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ACR70 (%)
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31.5 |
23.2 |
13.0 |
0.23 |
0.007 |
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EULAR response (%)
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53.4 |
49.0 |
19.5 |
0.63 |
<0.001 |
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DAS28 <2.6 (%)
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61.6 |
39.0 |
31.1 |
0.003 |
<0.001 |
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DAS28 ≤3.2 (%)
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74.7 |
57.6 |
37.8 |
0.014 |
<0.001 |
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DAS28
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2.4 (1.3) |
3.2 (1.6) |
3.5 (1.6) |
<0.001 |
<0.001 |
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DAS28 Δ
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-1.7 (1.3) |
-1.4 (1.5) |
–0.6 (1.4)
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0.17 |
<0.001 |
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Physician global(0-100)
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13.8 (12.9) |
23.5 (18.9) |
22.0 (17.3) |
<0.001 |
<0.001 |
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Physician global Δ
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-22.7 (19.9) |
-16.9 (27.3) |
-14.3 (23.6) |
0.05 |
0.01 |
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Patient global (0-100)
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27.8 (23.7) |
34.2 (22.9) |
38.2 (23.9) |
0.04 |
0.003 |
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Patient global Δ
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-25.5 (25.5) |
-20.8 (28.5) |
-14.9 (27.6) |
0.19 |
0.006 |
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MHAQ (0-3)
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0.36 (0.39) |
0.50 (0.44) |
0.50 (0.45) |
0.01 |
0.017 |
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MHAQ Δ
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–0.32 (0.42)
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–0.27 (0.45)
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–0.23 (0.42)
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0.40 |
0.15 |
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SF6D (0-1)
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0.71 (0.15) |
0.66 (0.13) |
0.65 (0.12) |
0.01 |
0.002 |
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SF6D Δ
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0.11 (0.14) |
0.07 (0.12) |
0.06 (0.13) |
0.02 |
0.003 |
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Mean (SD) unless otherwise indicated. MHAQ = Modified health assessment questionnaire SF-6D = Short form -6 dimensions.
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Disclosure:
K. M. Fagerli,
Abbott Immunology Pharmaceuticals,
8,
Pfizer Inc,
8,
Merck Pharmaceuticals,
8,
Roche Pharmaceuticals,
8;
E. Lie,
None;
D. van der Heijde,
Abbott Laboratories; Amgen; AstraZeneca; BMS; Centocor: Chugai; Eli-Lilly; GSK; Merck; Novartis; Pfizer; Roche; Sanofi-Aventis; Schering-Plough; UCB; Wyeth,
5,
Imaging Rheumatology,
4;
M. S. Heiberg,
None;
S. Lexberg,
Abbott Immunology Pharmaceuticals,
8,
Pfizer Inc,
8,
Roche Pharmaceuticals,
8,
Merck Pharmaceuticals,
8;
K. Mikkelsen,
None;
E. Rødevand,
None;
S. Kalstad,
None;
T. K. Kvien,
Abbott Immunology Pharmaceuticals,
8,
AstraZeneca,
8,
Merck Pharmaceuticals,
8,
NiCox, S.A.,
8,
Pfizer Inc,
8,
Roche Pharmaceuticals,
8,
UCB,
8,
BMS,
5,
Abbott Immunology Pharmaceuticals,
5,
Merck Pharmaceuticals,
5,
NiCox, S.A.,
5,
Pfizer Inc,
5,
Roche Pharmaceuticals,
5,
UCB,
5.
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