ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 500

Fixed Versus On-Flare Retreatment With Rituximab In RA – Results From The Cererra Collaboration

Katerina Chatzidionysiou1, Elisabeth Lie2, Evgeny Nasonov3, Galina Lukina3, Merete Lund Hetland4, Ulrik Tarp5, Karel Pavelka6, Cem Gabay7, Dan Nordström8, Helena Canhao9, Matija Tomsic10, Piet van Riel11, Juan Gomez-Reino12, Ioan Ancuta13, Tore Kvien14 and Ronald van Vollenhoven15, 1Dept of Medicine, Unit for Clinical Research Therapy. Inflammatory Diseases (ClinTrid), Karolinska Institute, Stockholm, Sweden, 2Dept. of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway, 3ARBITER, Institute of Rheumatology, Moscow, Russia, 4DANBIO, Department of Rheumatology, Copenhagen University Hospital at Glostrup, Copenhagen, Denmark, 5Department of Rheumatology, Aarhus University Hospital, Aarhus, Denmark, 6Department of Clinical and Experimental Rheumatology, Charles University, Prague, Czech Republic, 7SCQM registry, University Hospitals of Geneva, Geneva, Switzerland, 8ROB-FIN, Helsinki University Central Hospital, Helsinki, Finland, 9Rheumatology Research Unit, Rheumatology Research Unit, on behalf of the Rheumatic Diseases Portuguese Register, Instituto de Medicina Molecular, Rheumatology Research Unit, Rheumatology Research Unit, on behalf of the Rheumatic Diseases Portuguese Register, Lisbon, Portugal, 10Department of Rheumatology, BioRx.si, University Medical Centre Ljubjana, Ljubljana, Slovenia, 11Rheumatology, Radboud University Nijmegen Medical Centre, Nijmegen, Netherlands, 12Hospital Clinico Universitario de Santiago, Santiago de Compostela, Spain, 13Internal Medicine, Cantacuzino Hospital, Bucharest, Romania, 14Rheumatology, Diakonhjemmet Hospital, Oslo, Norway, 15Unit for Clinical Research Therapy. Inflammatory Diseases (ClinTrid), Karolinska Institute, Stockholm, Sweden

Meeting: 2013 ACR/ARHP Annual Meeting

Keywords:

Session Information

Title: Rheumatoid Arthritis Treatment - Small Molecules, Biologics and Gene Therapy I

Session Type: Abstract Submissions (ACR)

Background/Purpose: The data on how to optimally retreat patients with RA with rituximab (RTX) have been limited so far. The aim of this analysis was to compare two common retreatment strategies: A fixed retreatment approach (before flare) and retreatment when a flare occurs

Methods: Pooled data from the Collaborating European Registries for Rituximab in RA (CERERRA) project were used. RA patients who received at least 2 retreatments (3 courses) with RTX and for whom information about the strategy for retreatment was available (according to the physician’s opinion) were identified. The two retreatment strategies were compared by applying an adjusted mixed model analysis with DAS28 improvement as the dependent variable.

Results: A total of 800 patients were retreated at least 2 times: 616 retreated because of a flare (442 at 1st and 174 at 2nd retreatment) and 184 receiving fixed retreatment (128 at 1st and  56 at 2nd retreatment). Baseline characteristics (incl. age, sex, seropositivity, disease duration, number of prior DMARDs and biologics) at first course of RTX did not differ significantly between the two groups. However, patients retreated on flare had a significantly higher DAS28-ESR at the time of 1st retreatment (5.1±1.3 vs. 4.1±1.4, p<0.0001), and a higher HAQ (1.5±0.7 vs. 1.3±0.8, p=0.001), as expected. They had also a higher baseline (at the time of RTX start) DAS28 (6.3±1.0 vs. 6.1±1.2, p=0.03). Those retreated on flare were also more likely to be treated with corticosteroids (58% vs. 46%, p=0.01) but less likely to receive concomitant DMARDs (82% vs. 92%, p=0.005).

In figure 1 the baseline (=start of each cycle) DeltaDAS28 (compared to the DAS28 at the time of RTX start) for the two groups is shown. Patients receiving fixed retreatment had a significantly higher (in absolute number) DeltaDAS28 (p<0.0001) at the start of each cycle, compared to those retreated on-flare. In the adjusted mixed model analysis, we compared the two retreatment groups for the 1st and the 2nd retreatment separately using estimated marginal means. For the 1st retreatment a fixed retreatment yielded significantly better results than the “on-flare”: mean DeltaDAS28=-2.4 (95% CI: -3.0; -1.7) vs. -1.8 (95% CI: -3.6; -0.03), p<0.0001. Similar results were found for the 2nd retreatment: mean DeltaDAS28=-2.6 (95% CI: -3.1; -2.2) vs. -1.6 (95% CI: -1.8; -1.4), p<0.0001.

Conclusion: A fixed retreatment strategy with RTX in RA seems to be more effective than the retreat ‘on-flare’ strategy.

Disclosure:

K. Chatzidionysiou,
None;

E. Lie,

Pfizer Inc,

5,

Roche Pharmaceuticals,

5,

Abbott Immunology Pharmaceuticals,

5,

Bristol-Myers Squibb,

5;

E. Nasonov,
None;

G. Lukina,
None;

M. L. Hetland,

Pfizer, ROche og MSD.,

5;

U. Tarp,
None;

K. Pavelka,

Roche, BMS, Pfizer, MSD, AbbVie,

8;

C. Gabay,

Roche Pharmaceuticals,

2,

Roche, Abbvie, Pfizer, UCB, BMS, MSD,

5;

D. Nordström,
None;

H. Canhao,
None;

M. Tomsic,
None;

P. van Riel,
None;

J. Gomez-Reino,
None;

I. Ancuta,
None;

T. Kvien,
None;

R. van Vollenhoven,
None.

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