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Abstract Number: 851

A Tailored Approach to Reduce Dose of Anti-TNF Drugs Is Equally Effective, but Substantially Less Costly Than Standard Dosing in Patients with Ankylosing Spondylitis over One Year: A Propensity Score-Matched Cohort Study

Jakub Zavada1, Michal Uher2, Katarina Sisol3, Sarka Forejtova4, Katerina Jarosova5, Herman F. Mann6, Jiri Vencovsky7 and Karel Pavelka8, 1Charles University, Prague, Czech Republic, 2Institute of Biostatistics and Analyses, Masaryk University, Brno, Czech Republic, 3rheumatology, Institute of Rheumatology, Prague, Czech Republic, 4Rheumatology, Institute of Rheumatology, Prague, Czech Republic, 5Na Slupi 4, Institute of Rheumatology, Prague, Czech Republic, 6Institute of Rheumatology and Department of Rheumatology, 1st Faculty of Medicine, Charles University, Prague, Prague, Czech Republic, 7Institute of Rheumatology and Clinic of Rheumatology, 1st Faculty of Medicine, Charles University in Prague, Prague, Czech Republic, 8Institute of Rheumatology, Praha, Czech Republic

Meeting: 2014 ACR/ARHP Annual Meeting

Keywords: Ankylosing spondylitis (AS) and anti-TNF therapy

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Session Information

Session Title: Spondyloarthropathies and Psoriatic Arthritis I - Novel Treatments Axial Spondyloarthritis

Session Type: Abstract Submissions (ACR)

Background/Purpose: To compare effectiveness, safety and costs of standard versus individually tailored reduced doses of anti-TNF drugs in patients with Ankylosing Spondylitis (AS) after achieving low disease activity.
Methods:
This was a single center prospective observational study performed within the national biologics registry. The anti-TNF dose tapering strategy was chosen by treating physicians, without pre-specified protocol.  We used propensity score (PS) methodology to identify 2 cohorts of patients matched for relevant baseline characteristics (table 1) who were treated with either reduced (n=53) or standard (n=83) doses of TNF inhibitors. One year outcomes and costs of anti-TNF drugs were compared between both PS-matched cohorts.

Results: In the reduced dosing group the median dose of TNF inhibitor corresponded to 0.67, and 0.5 of the standard dose initially, and at 12 months resp., and 21% of patients required return to standard dosing regimen.  The mean change per year in BASDAI, CRP, HAQ and BASFI, as well as QALY area under the curve were no different between both groups (table 2).  The hazard ratio (95% confidence interval) of reduced versus standard dosing group for relapse and any adverse event was 1.46 (0.66; 3.19), and 0.56 (0.22; 1.44) resp. (Figure 1)  Mean difference (95% confidence interval) in cost of anti-TNF drugs was -4214 (-4707; -3701) € per year of treatment in favor of reduced dosing strategy.

Conclusion: In AS patients after reaching low disease activity, a tailored approach to reduce doses of anti-TNF drugs produced similar clinical outcomes at 1 year, but was substantially less costly.

Acknowledgements: This work was supported by project of MHCR for conceptual development of research organization 023728

 

 

Table 1 Baseline characteristics

 

 

 

Standard dosing group

Reduced dosing group

p-value

 

n=83

n=53

 

Female

n (%)

19 (22.9 %)

13 (24.5 %)

0.840

Age (years)

Mean (SD)

39.5 (9.3)

41.0 (10.8)

0.585

Weight (kg)

Mean (SD)

75.3 (13.5)

75.5 (14.9)

0.927

HLA B27 positive

n (%)

76 (91.6 %)

48 (90.6 %)

0.919

Disease duration prior to the start of anti-TNF therapy (years)

Mean (SD)

8.1 (7.0)

9.2 (8.5)

0.582

Duration of anti-TNF therapy (months)

Mean (SD)

37.4 (20.0)

34.8 (18.6)

0.443

Peripheral joint involvement

n (%)

29 (34.9 %)

18 (34.0 %)

0.911

CRP (mg/l)

Mean (SD)

4.4 (5.6)

4.3 (7.8)

0.713

BASDAI

Mean (SD)

1.4 (0.9)

1.4 (1.1)

0.796

HAQ

Mean (SD)

0.4 (0.5)

0.4 (0.4)

0.833

BASFI

Mean (SD)

1.9 (1.4)

1.8 (1.5)

0.644

Concomitant glucocorticoids

n (%)

4 (4.8 %)

1 (1.9 %)

0.460

Concomitant DMARD

n (%)

9 (10.8 %)

6 (11.3 %)

0.954

Anti-TNF agents

Etanercept, n (%)

31 (37.3 %)

25 (47.2 %)

0.515

 

Adalumumab, n (%)

19 (22.9 %)

11 (20.8 %)

 

Infiliximab, n (%)

33 (39.8 %)

17 (32.1 %)

First anti-TNF treatment

n (%)

68 (81.9 %)

46 (86.8 %)

0.466

Mann-Whitney U test and unconditional z-pooled test are used when comparing continuous and categorical variables, respectively (Fisherxs exact test is used when comparing anti-TNF agents).

 

 

Table 2 Measures of activity/function, quality of life, and costs of anti-TNF therapy over one year of observation

 

 

Standard dosing group

Reduced dosing group

p-value

 

 

n=83

n=53

 

BASDAI at baseline

Mean (SD)

1.4 (1.0)

1.4 (1.1)

0.796

BASDAI at 12 M

Mean (SD)

1.9 (1.5)

1.7 (1.3)

0.453

Change in BASDAI (per year)

Mean (95% CI)

0.47 (0.18; 0.76)

0.36 (0.01; 0.71)

0.615

Difference of mean change (per year)

Mean (95% CI)

reference

-0.12 (-0.57; 0.34)

CRP at baseline

Mean (SD)

4.4 (5.9)

4.3 (7.9)

0.713

CRP at 12 M

Mean (SD)

7.5 (15.6)

5.4 (7.9)

0.992

Change in CRP (per year)

Mean (95% CI)

3.42 (-0.16; 7.01)

2.19 (-2.09; 6.47)

0.663

Difference of mean change (per year)

Mean (95% CI)

reference

-1.23 (-6.81; 4.35)

HAQ at baseline

Mean (SD)

0.4 (0.4)

0.4 (0.4)

0.833

HAQ at 12 M

Mean (SD)

0.4 (0.4)

0.4 (0.5)

0.479

Change in HAQ (per year)

Mean (95% CI)

0.07 (0.00; 0.14)

0.08 (-0.01; 0.17)

0.942

Difference of mean change (per year)

Mean (95% CI)

reference

0.00 (-0.11; 0.12)

BASFI at baseline

Mean (SD)

1.9 (1.7)

1.8 (1.7)

0.644

BASFI at 12 M

Mean (SD)

2.1 (1.8)

1.9 (1.7)

0.481

Change in BASFI (per year)

Mean (95% CI)

0.07 (-0.21; 0.35)

0.09 (-0.24; 0.43)

0.907

Difference of mean change (per year)

Mean (95% CI)

reference

0.03 (-0.41; 0.46)

EQ-5D* utility at baseline

Mean (SD)

0.80 (0.09)

0.79 (0.11)

0.667

EQ-5D* utility at 12 months

Mean (SD)

0.78 (0.14)

0.78 (0.11)

0.901

QALY area under the curve**

Mean (SD)

0.78 (0.12)

0.76 (0.14)

0.436

Annual cost of anti-TNF therapy (€)

Mean (SD)

12 000 (-)

7 784 (2 254)

<0.001

Incremental effectiveness***

Mean (95% CI)

reference

-0.020 (-0.057; 0.016)

 

Incremental cost (€)***

Mean (95% CI)

reference

-4 214 (-4 707; -3 701)

 

Mann-Whitney U test was used when comparing continuous variables. Change (per year) was estimated using linear mixed effects regression model and restricted maximum likelihood method.

* EQ-5D utility was derived from BASDAI and BASFI. ** QALY was calculated as area under the curve of linearly interpolated values of EQ-5D utility. ***Incremental cost and effectiveness are differences between groups estimated from 10000 bootstrap samples.

Figure 1


Disclosure:

J. Zavada,
None;

M. Uher,
None;

K. Sisol,
None;

S. Forejtova,
None;

K. Jarosova,
None;

H. F. Mann,
None;

J. Vencovsky,
None;

K. Pavelka,
None.

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