Correlation Between Time to Switch and Clinical Response Amplitude to Rituximab in Second Line Treatment in Rheumatoid Arthritis Patients with Treatment Failure to Tumor Necrosis Factor Inhibitors: 3-Year Data from Repeat Observational Study

Ioan Ancuta¹, Ruxandra Ionescu², Catalin Codreanu³, Andra Balanescu², Elena Rezus⁴, Maria Suta⁵, Paulina Ciurea⁶, Mihaela Milicescu⁷, Dan Nemes⁸, Codrina Ancuta⁹, Mihai Bojinca¹⁰, Magda Parvu¹¹ and Horatiu Popoviciu¹², ¹“Dr. I. Cantacuzino” Hospital, Bucharest, Romania, ²Rheumatology, Sfanta Maria Clinical Hospital, UMF Carol Davila, Bucharest, Romania, ³5 Thomas Masaryk Street, 'Dr. Ion Stoia' Clinical Center of Rheumatic Diseases, Bucharest, Romania, ⁴Rheumatology, Recovering Clinical Hospital, Iasi, Romania, ⁵317 Tomis Str. , Bl. 4A, ap. 3, Constanta Municipal Hospital, Constanta, Romania, ⁶Clinical County Hospital,Craiova, Craiova, Romania, ⁷Rheumatology, "Dr. I. Cantacuzino" Clinical Hospital, Bucharest, Romania, ⁸Rehabilitation and Rheumatology, ”Victor Babes” University of Medicine and Pharmacy, Timisoara, Romania, ⁹G.T.Popa Center for Biomedical Research, Iasi, Romania, ¹⁰Internal Medicine, “Dr. I. Cantacuzino” Hospital, Bucharest, Romania, ¹¹Rheumatology, Colentina Clinical Hospital, Bucuresti, Romania, ¹²Rheumatology, University of Medicine and Pharmacy Targu Mures, Tg Mures, Romania

Meeting: 2014 ACR/ARHP Annual Meeting

Keywords: Biologics, rheumatoid arthritis (RA) and rituximab

Session Information

Title: Rheumatoid Arthritis - Small Molecules, Biologics and Gene Therapy: Therapeutic Strategies, Biomarkers and Predictors of Outcomes in Rheumatoid Arthritis

Session Type: Abstract Submissions (ACR)

Background/Purpose:

In recent years we assist to an increasing interest to get more clinical data to improve the control of disease course in rheumatoid arthritis (RA) patients. According to treat to target principle, best practice still needs to be better defined in patients that encounter inadequate response after a variable period of time to anti-TNF treatment.To investigate the clinical impact of switching to rituximab (RTX) according to the length of previous anti-TNF treatment in routine practice setting in patients suffering from RA and failure to TNF inhibitors.

Methods:

REPEAT is an open-label, multicenter, prospective observational local study, 1087 patients with active RA and inadequate response to at least one TNF inhibitor received initial RTX (2×1000 mg IV, at 2 weeks apart) and subsequent RTX courses have been enrolled from 2010 to 2013. The patients were stratified according to the length of anti-TNF treatment before switch: <12 months (group A=260), 12-24 months (group B=278) and >24 months (group C=526). Clinical assessments including 28-joint disease activity score (DAS-28) were performed at baseline (switch moment) and after each retreatment course at 6, 12, 18, 24, 30 and 36 months. For the purpose of this analysis, median DAS-28 values were calculated for each group (A,B and C)and followed by median Delta Δ DAS-28 values calculation, as differences between values found at two successive evaluations and also from baseline to each evaluation. Statistical analyses were performed with STATA SE 11.0 software. Comparison between all previous treatments and evaluations for disease activity were performed using Nptrend and ANOVA tests.

Results:

Median values for Δ DAS-28 obtained for group A, group B and group C from baseline to 6 months were -1,65;-1,35;-1,33 (P=0.01), from baseline to 12 months: -2,43;-2,05;-2,17 (P=0.02), from baseline to 18 months: -2,96;-2,59;-2,49 (P=0.009), from baseline to 24 months: -3,26;-2,83;-2,57 (P=0.01), from baseline to 30 months: -2,58;-2,7;-2,66 (P=0.15) and from baseline to 36 months: -2,56;-2,54;-2,83 (P=0.9). The median Δ DAS-28 achieved in group A at 1 year (-2.43) is comparable with Δ DAS-28 obtained at 18 month in group B (-2.59) and group C (-2.49). Across evaluations Nptrend test was P<0.0001 and ANOVA was P<0.0001.

Conclusion:

1. The median values of Δ DAS-28 as a measure of the amplitude of response to RTX show robust data that support the sustained clinical response to RTX across all 3 groups of patients over the 36 months treatment observation.

2. It is a significant difference between median values of Δ DAS-28 for group A and group B and C, showing a deeper and faster clinical response achieved in patients who were switched earlier to RTX in second line after anti-TNF treatment failure, with a pick at 24 months.

Disclosure:

I. Ancuta,
None;

R. Ionescu,
None;

C. Codreanu,
None;

A. Balanescu,
None;

E. Rezus,
None;

M. Suta,
None;

P. Ciurea,
None;

M. Milicescu,
None;

D. Nemes,
None;

C. Ancuta,
None;

M. Bojinca,
None;

M. Parvu,
None;

H. Popoviciu,
None.

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