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Abstract Number: 383

2002-04 Vs.2007-09: Initiation of Combination, and Tapering/Discontinuation (DC) Patterns of TNFi and MTX in a US (RA) Patient Registry: Analysis with CDAI Scores

Deborah Wenkert1, Shannon Grant2, David H. Collier3, Andrew S. Koenig4 and Joel M. Kremer5, 1Inflammation TA, Amgen Inc., Thousand Oaks, CA, 2Axio Research LLC, Seattle, WA, 3Amgen Inc., Thousand Oaks, CA, 4Specialty Care, Pfizer Inc, Collegeville, PA, 5Center for Rheumatology, Albany Medical College, Albany, NY

Meeting: 2012 ACR/ARHP Annual Meeting

Keywords: combination therapies and rheumatoid arthritis (RA)

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Session Information

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

Session Type: Abstract Submissions (ACR)

Background/Purpose:

We compared patient (pt) characteristics, for initiating, tapering and DC of TNFi/MTX combination therapy (CT), among RA pts seen during 02-04 vs. 07-09 to detect changes in practice.

Methods:

In the Consortium of Rheumatology Researchers of North America (CORRONA), a rheumatoid arthritis (RA) registry, the relationship between maximum CDAI(Clinical Disease Activity Index)  and the use of CT during the 2 time intervals was compared using all RA pts in CORRONA and those with >=2 yrs of follow-up (f/u) (N=4955; N= 6847).  DC’ing/tapering MTX, TNFi, or both and reasons for DC’ing were compared among the subset who initiated CT (n=315; n=697 respectively).

Results:

Among pts receiving CT, age, gender and patterns of adding TNFi to MTX vs. MTX to TNFi were similar in the 2 time periods; The mean CDAI at CT initiation (for all pts and pts with >=2 yr f/u) was lower in 07-09 (18.6 and 18.3 vs. 14.6 and 14.0, p<0.001). 35% of all pts starting CT were on prednisone at initiation during the 02-04 interval vs. 30.4% during 07-09, p=0.084.  Among all RA pts with 2 yrs of f/u a higher percentage of patients initiated CT in 07-09 than 02-04 in each maximum CDAI category.  Although MTX DCing rates were similar between the 2 time periods, tapering was more frequent in the 07-09 (51%) vs 02-04 cohort (38.8%), p = 0.029. DCing (or switching) the TNFi occurred among 37% of pts initiating CT  during 07-09 vs. 31.7% (02-04) p=0.105. Baseline CDAI did not predict DC patterns. The mean CDAI at time of DC was higher in the 02-04 cohort for MTX, TNFi or both with overall mean CDAIs (02-04 vs. 07-09) at the time of DC of CT of 19.4 vs. 13.2 p<0.001. The mean CDAI at time of DC of prednisone, was similar between the two time periods (15.2 vs. 15.0) p=NS.

Physician-recorded reasons for DC’ing MTX or TNFi were consistent across time intervals.

Conclusion:

We found lower CDAIs among those initiating CT between 07-09 and lower CDAIs among those weaning or stopping CT in 2 yrs of f/u, perhaps reflecting stricter definition and implementation of aggressive treatment goals in the later time periods.

RA pts with 2 yr F/U after a visit in

2002-2004

2007-2009

Total

N

4955

6847

11,802

% of pts with a max CDAI during the 2 yr F/U who DID NOT receive CT anytime during the 2yr

p-value

   Max CDAI 10-22

80.8 %

74.3 %

<0.001

   Max CDAI >22

74.2 %

71.1%

0.038

RA pts with 2 yr F/U after initiating CT

2002-2004

2007-2009

Total

N

315

697

1012

% of RA pts DCing CT during 2 yrs F/U

p-value

   DC only MTX (continuing TNFi)

15.2 %

13.1 %

0.350

   DC only TNFi (continuing MTX)

31.7 %

37.0 %

0.105

   DC both MTX + TNFi

7.9 %

6.5 %

0.390

   DC Prednisone

33.6 %

43.5 %

0.085

CDAI (SD) at time of DC of RA pts who DC

p-value

   MTX only

14.2 (11.0)

10.6 (12.2)

0.088

   TNFi only

20.5 ( 14.0)

14.5 ( 13.0)

<0.001

   both MTX + TNFi

25.1 (17.2)

10.9 (10.1)

<0.001

   DC Prednisone

15.2 (12.7)

15.0 (15.0)

0.951

 


Disclosure:

D. Wenkert,

Amgen,

1,

Amgen,

3;

S. Grant,

Axio Research LLC,

3;

D. H. Collier,

Amgen Inc.,

1,

Amgen Inc.,

3;

A. S. Koenig,

Pfizer Inc,

3,

Pfizer Inc,

1;

J. M. Kremer,

Bristol-Myers Squibb, Genentech, Pfizer, UCB, HGS,

2,

Amgen, Abbott, Genetech, Pfizer,

5,

Amgen, Abbott, BMS ,

8,

Corrona ,

4.

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