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Abstract Number: 416

Changes In Body Composition On Two Different Glucocorticoid Regimens In Early RA: Experience From The Cobra-Light Trial

Nicole P.C. Konijn1, Karin Britsemmer2, Marieke M. ter Wee1, Debby den Uyl1, Birgit S. Blomjous1, Maarten Boers3,4, Dirkjan van Schaardenburg5,6, Willem F. Lems1,6 and Michael T Nurmohamed5,7, 1Rheumatology, VU University Medical Center, Amsterdam, Netherlands, 2Jan van Breemen Research Institute | Reade, Amsterdam, Netherlands, 3Epidemiology & Biostatistics, VU University Medical Center, Amsterdam, Netherlands, 4Deapartment of Epidemiology and Biostatistics, Jan van Breemen Research Institute/Reade, Amsterdam, Netherlands, 5VU University Medical Center, Amsterdam, Netherlands, 6Jan van Breemen Research Institute/Reade, Amsterdam, Netherlands, 7Rheumatology, Jan van Breemen Research Institute/Reade, Amsterdam, Netherlands

Meeting: 2013 ACR/ARHP Annual Meeting

Keywords: adipose tissue, body mass, Early Rheumatoid Arthritis, glucocorticoids and obesity

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Session Information

Title: Rheumatoid Arthritis - Clinical Aspects I: Comorbidities in Rheumatoid Arthritis

Session Type: Abstract Submissions (ACR)

Background/Purpose:

Prednisolone improves joint inflammation and disease severity in rheumatoid arthritis (RA), but is associated with multiple cardiovascular, metabolic and endocrine side effects and may negatively influence body composition (BC) [1,2]. Rheumatoid cachexia (i.e. loss of lean mass [LM] and gain in fat mass [FM]) is often observed among RA patients, with deleterious effects on morbidity and functional capacity [2]. The net effect of prednisolone on BC in active RA is unknown. The aim of this study was to determine if different dosages of prednisolone have different effects on BC in early RA patients.

 

Methods:

In total, 164 patients with early, active RA were randomised to either COBRA therapy (prednisolone starting at 60 mg/day tapered to 7.5 mg/day in 6 weeks, methotrexate 7.5 mg/week and sulfasalazine 2 g/day; cumulative prednisolone dose at 26 weeks 2.3 g, mean dose: 12.5 mg/day; n = 81) or COBRA light therapy (prednisolone starting at 30 mg/day tapered to 7.5 mg/day in 9 weeks and methotrexate escalated to 25 mg/week in 9 weeks; cumulative prednisolone dose 1.8 g, mean dose: 9.6 mg/day) (n = 83) [3]. Of these, 40 resp. 42 had BC assessments by whole body DXA scans at baseline (BL) and after 26 weeks of treatment. These patients were similar to the other patients with respect to demographics and baseline disease severity (data not shown). Main outcomes of the trial included disease activity (DAS44) and physical functioning (HAQ).

 

Results:

Mean age was 51 years, 67 % were female, median symptom duration was 16 weeks. At baseline, median BMI was above the upper limit of normal in both groups (Table 1); 48% (COBRA) vs. 36% (COBRA light) were classified as overweight, and 15% vs. 19% as obese.

In both groups, DAS44 and HAQ decreased significantly after 26 weeks of treatment. In the COBRA group the effect on HAQ was more prominent at week 13 (data not shown). Both groups gained weight (median 1-2 kg) with slight but significant deterioration in BC parameters: increases in BMI, total FM, truncal FM, FM of arms and legs and BF%, without significant differences between treatment groups. Interestingly, in the COBRA treatment group, total LM and LM of arms and legs increased significantly, with a trend for significant difference between both groups (p=0.058 and p=0.070, resp.).

 

Conclusion:

This study suggests a potentially negative effect of intermediate dose prednisolone treatment on body composition in RA patients, as multiple fat mass parameters indicated a more unfavourable body composition after 26 weeks. The increase of lean mass in the COBRA treatment group also suggests positive effects, possibly explained by a rapid improvement in physical functioning. Results have to be interpreted with caution as most patients were overweight, and body composition before the onset of RA was not recorded.

 

Reference 1: Townsend & Saag, Clin Exp Rheumatology 2004

Reference 2: Engvall et al, Scand J Rheumatology 2011

Reference 3: den Uyl et al, ARD 2013

 

Table 1. Changes in disease activity, physical functioning and body composition parameters after 26 weeks prednisolone treatment

 

 

COBRA group (n=40)

COBRA light group (n=42)

 

(mean pred 12,5 mg/d)

(mean pred 9,6 mg/d)

 

Week 0

Δ after 26 weeks

Week 0

Δ after 26 weeks

 

 

 

 

 

Disease Activity Score (DAS44)

3.87 (0.75)

-2.37 (1.17)*

3.95 (0.91)

-2.22 (1.11)*

Health Assessment Questionnaire (HAQ)

1.25 [0.75]

-0.94 [1.03]*

1.13 [1.12]

-0.57 [0.90]*

Body Weight (Total Body Mass, kg)

76.4 [15.1]

2.4 [2.8]*

72.6 [22.8]

1.3 [4.5]*

Body Mass Index (kg/m2)

25.7 [4.5]

0.7 [1.2]*

25.1 [7.1]

0.4 [1.8]*

Fat Mass (kg)

23.4 [12.4]

1.5 [2.6]*

23.3 [15.2]

1.8 [3.3]*

– on trunk (kg)

13.0 [8.4]

1.0 [1.8]*

11.3 [10.8]

0.5 [2.4]*

– on arms & legs (kg)

10.0 [4.9]

0.7 [1.3]*

10.5 [4.8]

0.4 [1.1]*

– trunk/arms & legs (truncal distribution) FM (kg)

1.19 [0.70]

0.01 [0.13]

1.10 [0.53]

-0.01 [0.16]

– Fat Mass/Total Mass (% Body Fat)

32% [14%]

1% [3%]*

35% [13%]

1% [3%]*

Lean Mass (kg)

45.4 [10.2]

0.3 [1.6]*

43.7 [15.4]

0.1 [1.3]

– on arms & legs (kg)

20.5 [6.4]

0.2 [1.2]*

19.0 [8.7]

0.1 [0.8]

Data are presented as mean (SD) for normally distributed variables and as median [IQR] for non-parametric variables;*significant difference between week 0 and 26 within treatment group (p<0.05);

 

 

 

 

 

 

 


Disclosure:

N. P. C. Konijn,
None;

K. Britsemmer,
None;

M. M. ter Wee,
None;

D. den Uyl,
None;

B. S. Blomjous,
None;

M. Boers,

Roche, Celgene, Horizon, Mundifarma, UCB, BMS,

5, 9,

Novartis Pharmaceutical Corporation,

9;

D. van Schaardenburg,
None;

W. F. Lems,

Abbott, Mercke and Roche,

5;

M. T. Nurmohamed,

Roche, Schering-Plough, BMS, UCB, Wyeth, Pfizer and MSD,

5,

Abbott, Roche, Pfizer, BMS,

9,

Abbot, Roche, Pfizer, UCB,

9.

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