ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 365

Improvement of Health-Related Quality of Life in RA Patients Treated with Biologics – One-Year Follow-up Data of the German Biologics Register Rabbit

Kerstin Gerhold1, Adrian Richter2, Matthias Schneider3, Hans Joachim Bergerhausen4, Winfried Demary5, Anke Liebhaber6, Joachim Listing7, Angela Zink8 and Anja Strangfeld9, 1Programme Area of Epidemiology, German Rheumatism Research Center, a Leipniz Institute, Berlin, Germany, 2German Rheumatism Research Center, Berlin, Germany, 3Rheumatology, Heinrich-Heine-University, Düsseldorf, Germany, 4Klinik für Rheumatologie, Wedau Kliniken - Klinikum Duisburg, Duisburg, Germany, 5Private Practice, Hildesheim, Germany, 6Private Practice, Halle, Germany, 7German Rheumatism Research Center, a Leipniz Institute, Berlin, Germany, 8Epidemiology Unit, German Rheumatism Research Center, a Leipniz Institute, Berlin, Germany, 9Programme Area Epidemiology, German Rheumatism Research Center, a Leipniz Institute, Berlin, Germany

Meeting: 2012 ACR/ARHP Annual Meeting

Keywords: ,

Session Information

Title: Rheumatoid Arthritis - Clinical Aspects I: Drug Studies/Drug Safety/Drug Utilization/Disease Activity & Remission

Session Type: Abstract Submissions (ACR)

Background/Purpose: Health‐related quality of life (HRQoL) has been increasingly recognized as a crucial indicator of disease burden in chronic diseases such as rheumatoid arthritis (RA). To measure the effectiveness of biologic disease modifying anti-rheumatic drugs (bDMARDs) on patient-assessed disease burden, we investigated the one-year course of HRQoL in a cohort of RA patients treated with bDMARDs or synthetic DMARDs (sDMARDs) after failure of at least one DMARD.

 

Methods: Patients enrolled in the German biologics register RABBIT from 2006 up to 2010 with a minimal observation period of one year were included. SF-36 questionnaire was used to capture patient-assessed mental and physical health at baseline and after one year of follow-up. Disease activity was measured by means of DAS28, patient-assessed functional capability by means of the FFbH (Funktionsfragebogen Hannover) score. We applied last-observation-carried-forward (LOCF) method for patients discontinuing initial therapy and patients who were lost to follow-up from the ITT-population. Level of statistical significance for differences between baseline and one-year follow-up values of physical and mental health subscales was set at a=0.00625 using Bonferroni correction for multiple testing of the 8 subscales (paired t-test for pre-treatment versus post-treatment comparisons, two-sided).

Results : Data of 804 patients treated with TNF inhibitors (anti-TNF), 234 patients treated with tocilizumab (TOC), 450 patients treated with rituximab (RTX), 124 patients treated with abatacept (ABA), and of 816 patients treated with sDMARDs were included in the analysis. LOCF was used in 226 anti-TNF patients, 58 TOC, 57 RTX, 43 ABA and 158 sDMARD patients. Mean disease duration at baseline was between 10.1 and 13.9 years in the bDMARD groups, and 6.0 years in the sDMARD group. At baseline all bDMARD groups showed higher disease activity, lower functional capacity and poorer values for all subscales of physical and mental health than the sDMARD group. At one-year follow-up, disease activity, functional capacity as well as all SF-36 scales had improved in all treatment groups. However, bDMARD patients developed greater improvement, especially in the mental health subscales, compared to sDMARD patients.

Conclusion : Patients treated with bDMARDs had a worse disease state due to disease activity and functional capacity at enrollment, compared to patients on sDMARDs, which reflects treatment choices in daily care. All bDMARDs improved patientsx HRQoL beyond control of disease activity and physical function. Benefit of treatment with bDMARDs was particularly noticeable in the mental health subscales of the SF-36.

Disclosure: RABBIT is supported by unconditional grants from Abbott, Amgen/Biovitrum, Bristol Myers Squibb, MSD SHARP & DOHME, Pfizer, Roche, and UCB.

Table 1. Mean values of SF36 scales and improvement after one year (D=mean(1-year)-mean(baseline))

 

 

Anti-

TNF

TOC

RTX

ABA

s-

DMARD

Anti-

TNF

TOC

RTX

ABA

s-

DMARD

SF36 scales

Mean values at baseline

Improvement [D]

Physical

Health

Scales

Physical Function

45.1

39.7

37.5

37.5

55.0

5.9*

7.0*

4.6*

4.5

1.7

Physical Role

24.4

19.6

18.1

17.9

33.7

11.8*

17.9*

10.9*

4.8

9.1*

Body Pain

31.2

29.8

30.0

26.1

39.1

12.3*

13.9*

9.8*

8.8*

7.7*

General Health

40.8

40.0

39.3

35.0

46.9

5.1*

7.6*

4.6*

3.4

2.3*

Mental

Health

Scales

Vitality

37.2

37.1

32.5

32.5

44.2

5.7*

7.0*

4.5*

4.3*

3.3*

Social Function

61.9

56.9

56.9

55.5

68.3

6.1*

7.8*

6.1*

6.6*

2.8*

Role Emotional

50.3

48.2

44.4

41.7

54.1

7.8*

9.2*

7.8*

9.4

4.0

Mental Health

57.2

59.9

56.5

54.3

59.9

4.9*

4.4*

3.1*

5.2*

1.9*

 

 

 

 

 

 

 

 

 

 

 

 

Disease activity

DAS28 (ESR)

5.2

5.6

5.5

5.6

4.6

-1.4*

-2.1*

-1.2*

-1.2*

-1.0*

Functional capability

FFbH

65.1

60.0

53.5

53.8

72.1

4.4*

3.9*

7.1*

4.8*

2.8*

 

Disclosure:

K. Gerhold,
None;

A. Richter,
None;

M. Schneider,
None;

H. J. Bergerhausen,
None;

W. Demary,
None;

A. Liebhaber,
None;

J. Listing,

Abbott, Amgen/Biovitrum, Bristol Myers Squibb, MSD SHARP & DOHME, Pfizer, Roche, and UCB,

2;

A. Zink,

Abbott, Amgen/Biovitrum, Bristol Myers Squibb, MSD SHARP & DOHME, Pfizer, Roche, and UCB,

2;

A. Strangfeld,

Abbott, Amgen/Biovitrum, Bristol Myers Squibb, MSD SHARP & DOHME, Pfizer, Roche, and UCB,

2.

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