ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 1526

Sustained Clinical Efficacy after Multiple Courses of Rituximab in Rheumatoid Arthritis Patients with Inadequate Response to Tumor Necrosis Factor Inhibitors: 3-Year Data 

Catalin Codreanu1, Ruxandra Ionescu2, Ioan Ancuta3, Corina Mogosan4, Simona Rednic5, Paulina Ciurea6, Maria Suta7, Magda Parvu8, Andra Balanescu2, Mihai Bojinca3, Dan Nemes9, Codrina Ancuta10 and Elena Rezus11, 15 Thomas Masaryk Street, 'Dr. Ion Stoia' Clinical Center of Rheumatic Diseases, Bucharest, Romania, 2Rheumatology, Sfanta Maria Clinical Hospital, UMF Carol Davila, Bucharest, Romania, 3Internal Medicine and Rheumatology, Carol Davila University of Medicine and Pharmacy & Cantacuzino Hospital, Bucharest, Romania, 4'Dr. Ion Stoia' Clinical Center of Rheumatic Diseases, Bucharest, Romania, 5Rheumatology, University of Medicine and Pharmacy, Cluj-Napoca, Romania, 6Clinical County Hospital,Craiova, Craiova, Romania, 7317 Tomis Str. , Bl. 4A, ap. 3, Constanta Municipal Hospital, Constanta, Romania, 8Rheumatology, Colentina Clinical Hospital, Bucuresti, Romania, 9Rehabilitation and Rheumatology, ”Victor Babes” University of Medicine and Pharmacy, Timisoara, Romania, 10G.T.Popa Center for Biomedical Research, Iasi, Romania, 11Rheumatology, Recovering Clinical Hospital, Iasi, Romania

Meeting: 2014 ACR/ARHP Annual Meeting

Keywords: , ,

Session Information

Title: Rheumatoid Arthritis - Small Molecules, Biologics and Gene Therapy: Novel therapies, Biosimilars, Strategies and Mechanisms in Rheumatoid Arthritis

Session Type: Abstract Submissions (ACR)

Background/Purpose

Efficacy and safety of multiple courses of biologics used over extended periods of time in rheumatoid arthritis (RA) is still a medical debate. The purpose: to assess clinical efficacy of subsequent courses with Rituximab (RTX) in patients with active RA despite treatment with a TNF inhibitor in routine clinical practice in Romania.

Methods

Open-label, multicenter, prospective observational study started in 2010,using RTX every 6 months. Clinical efficacy included DAS-28, SDAI and CDAI at baseline and at  6, 12, 18, 24, 30 and 36 months. Δ DAS-28, Δ SDAI and Δ CDAI were calculated based on two consecutive evaluations.  Statistical analyses: STATA SE/11.  

Results

1087 patients with active RA and inadequate response to at least one TNF inhibitor who received an initial RTX treatment were included. Their average age at entry was  56.2 ± 11.2 yrs (mean ± SD) and  86% were women.  The mean values of disease activity scores steadily decreased after each retreatment indicating significant improvement.

 

Evaluation

DAS-28 (mean±SD)

SDAI (mean± SD)

CDAI (mean ±SD)

Baseline

5.57 ± 1.48(n=1071)*

29.5±15.98(n=1057)**

27.33±15.07(n=1071)

6 months

4.03 ± 1.13 (n=1060)

13.84±9.33(n=1041)

12.5±8.82(n=1060)

12 months

3.4 2 ± 0.96 (n=968)

9.16±7.48(n=938)

7.83±6.69(n=968)

18 months

3.02 ± 0.86 (n=775)

6.58±5.63(n=761)

5.45±5.12(n=775)

24 months

2.8 ± 0.76 (n=585)

5.43±5.07(n=574)

4.21±4.22(n=585)

30 months

2.69 ± 0.85 (n=386)

5.55±5.49(n=379)

4.15±4.78(n=386)

36 months

2.56 ± 0.83 (n=164)

5.27±5.1(n=159)

3.92±4.2(n=164)

*Patient’s number (n) decreases in time because of the enrolment timeframe and represents the number of patients who reached each evaluation ** SDAI patient’s /number is lower as CRP was not determined in all patients. Remission rate progressively increased after each retreatment course: 9.43% (100/1060 pts), 19.32% (187/968 pts), 31.48% (244/775 pts), 41.54% (243/585 pts), 44.56% (172/386 pts) and 51.83% (85/164 pts), whereas initial percentage of patients showing high disease activity (HDA) (66.2%=709/1071 pts) decreased to 18.02% (191/1060 pts), 4.44% (43/968 ps), 1.81% (14/775 pts), 0.68% (4/585 pts), 1.04% (4/386 pts) and 1.22% (2/164 pts) at 6, 12, 18, 24, 30 and 36 months, respectively. Similar trends were observed in SDAI and CDAI scores. All Δ DAS-28, Δ SDAI and Δ CDAI changes, as well as DAS-28 vs. SDAI and DAS-28 vs. CDAI comparisons were statistically significant (p<0.0001).

Conclusion

Our study showed a sustained improvement of clinical response after each retreatment course with RTX.

Disclosure:

C. Codreanu,
None;

R. Ionescu,
None;

I. Ancuta,
None;

C. Mogosan,
None;

S. Rednic,
None;

P. Ciurea,
None;

M. Suta,
None;

M. Parvu,
None;

A. Balanescu,
None;

M. Bojinca,
None;

D. Nemes,
None;

C. Ancuta,
None;

E. Rezus,
None.

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