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Abstract Number: 389

Oral Glucocorticoid Sparing Effects of Rituximab in Rheumatoid Arthritis Patients Who Have Switched from an Anti-TNF Therapy – an Administrative Claims Database Analysis

Stephen Johnston1, Tripthi Kamath2, Nianwen Shi3, Robert Fowler3, Bong-Chul Chu3 and William Reiss4, 1Truven Health Analytics, Bethesda, MD, 2Genentech, South San Francisco, CA, 3Truven Health Analytics, Washington, DC, 4Genentech Inc., South San Francisco, CA

Meeting: 2012 ACR/ARHP Annual Meeting

Keywords: glucocorticoids, rheumatoid arthritis, treatment and rituximab

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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: The current treatment paradigm in RA is to attempt to decrease concomitant use of oral glucocorticoids (OGC). This study examined the OGC-sparing effects of Rituximab in U.S. RA patients who had switched from an anti-TNF therapy.

Methods: Retrospective cohort study using a large U.S. administrative claims database. Patients selected for study were adults aged ≥18 years who had had been diagnosed with RA between 1/1/2004-3/31/2011 had initiated Rituximab treatment after treatment with anti-TNF therapy between 3/1/2006-3/31/2011, and had OGC use within 30 days prior to Rituximab initiation. Rituximab ‘exposure periods’ were constructed using Rituximab infusion dates and the recommended administration frequency schedule, equaling the duration of time from initiating Rituximab until the first occurrence of 1) switch to a different biologic disease modifying antirheumatic drug (BDMARD), 2) 90-day gap in treatment with Rituximab, 3) disenrollment from health insurance, 4) reaching 3/31/2011, or 5) reaching a maximum study follow-up of 36 months. Patients were excluded if within the 12-month period prior to Rituximab initiation they had been diagnosed with a non-RA indication for any BDMARD.

During the Rituximab exposure periods the study outcomes, proportion of patients using OGCs and average OGC dose expressed in prednisone equivalent, were measured in sequential 90-day intervals, the first of which commenced as of Rituximab initiation. A multilevel random coefficient model was used to test for statistically significant OGC-sparing effects over time.

Results: A total of 952 Rituximab exposure periods from 938 unique patients were included for study; average age 54.7 years, 79.2% female. Table displays the study results. The proportion of patients using OGCs decreased over time, with slight non-monotonic fluctuations, from 80.6% of patients in months 1-3 to 54.1% of patients remaining on therapy in months 34-36. The mean OGC dose also decreased over time, again with slight non-monotonic fluctuations, from 5.7 mg among patients in months 1-3 to 3.2 mg among patients remaining on therapy in months 34-36. The decreases in the proportion of patients using OGCs (P<0.0001) and the average OGC dose (P<0.0001) were both statistically significant. In sensitivity analysis subset to only patients remaining on therapy through months 34-36, the OGC use patterns were similar to those from among overall sample.

Conclusion: In this study, statistically significant OGC-sparing effects were observed in RA patients who had switched to Rituximab after treatment with anti-TNF therapy. The clinical implications of such OGC-sparing effects warrant further investigation.

Table. OGC use over time since Rituximab initiation

Month range

Sample N

% using OGCs

OGC dose*

 

 

 

Mean

SD

 

 

 

 

 

1-3

952

80.6%

5.7

7.4

4-6

864

79.3%

5.5

6.1

7-9

715

73.6%

5.0

5.9

10-12

594

67.7%

5.0

6.3

13-15

381

69.0%

4.5

5.4

16-18

313

64.2%

4.4

5.8

19-21

242

59.1%

4.3

7.1

22-24

191

58.1%

3.4

4.6

25-27

162

56.2%

3.5

5.8

28-30

129

55.8%

4.0

9.2

31-33

98

57.1%

3.1

3.5

34-36

74

54.1%

3.2

4.1

*Average daily dose, expressed in prednisone equivalent (mg), calculated among all patients


Disclosure:

S. Johnston,

Truven Health Analytics,

3;

T. Kamath,

Genentech, Inc,

3;

N. Shi,

Truven Health Analytics,

3;

R. Fowler,

Truven Health Analytics,

3;

B. C. Chu,

Truven Health Analytics,

3;

W. Reiss,

Genentech,

3.

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