Corticosteroid Sparing Effect of Non-TNF Targeted Biologics, Rituximab, Abatacept and Tocilizumab in Common Practice: Data from 3183 Patients Enrolled in the French Society of Rheumatology Registries

Jacques-Eric Gottenberg¹, Jacques Morel², Arnaud Constantin³, Thomas Bardin⁴, Alain Cantagrel⁵, Bernard Combe², Maxime Dougados⁶, René-Marc Flipo⁷, Alain Saraux⁸, Thierry Schaeverbeke⁹, Jean Sibilia¹⁰, Martin Soubrier¹¹, Olivier Vittecoq^12,13, Gabriel Baron¹⁴, Elodie Perrodeau¹⁵, Philippe Ravaud¹⁴ and Xavier Mariette¹⁶, ¹CNRS, Immunopathologie et Chimie Thérapeutique/Laboratory of Excellence Medalis, Institut de Biologie Moléculaire et Cellulaire, Strasbourg, France, ²Rheumatology, CHU Lapeyronie and Montpellier University, Montpellier, France, ³Rheumatology, CHU Purpan - Hopital Pierre-Paul Riquet, Toulouse, France, ⁴Clinique de Rhumatologie, Hopital Lariboisiere, Paris Cedex 10, France, ⁵Department of Rheumatology, Purpan Hospital, Toulouse III University, Toulouse, France, Toulouse, France, ⁶Rheumatology, Paris Descartes University, Paris, France, ⁷Rheumatology, Department of Rheumatology, CHU Teaching Hospital Lille, France., Lille, France, ⁸Rheumatology, Brest University Hospital, Brest, France, ⁹Department of Rheumatology, Bordeaux University Hospital, BORDEAUX, France, ¹⁰Department of Rheumatology, Strasbourg University Hospital, Strasbourg, France, ¹¹Rheumatology, Department of Rheumatology, CHU Gabriel Montpied, Clermont-Ferrand, France, ¹²INSERM U905 & Normandy University, Institute for Research and Innovation in Biomedicine, Rouen, France, ¹³Rheumatology Department and INSERM U 905, CHU Rouen, Rouen, France, ¹⁴Hôpital Hôtel Dieu, Paris, France, ¹⁵Epidemiology, Hopital Hotel Dieu, Paris Descartes University, Paris, France, ¹⁶Université Paris-Sud, AP-HP, Hôpitaux Universitaires Paris-Sud, Paris, France

Meeting: 2017 ACR/ARHP Annual Meeting

Date of first publication: September 18, 2017

Keywords: corticosteroids, registries and rheumatoid arthritis (RA)

Session Information

Date: Monday, November 6, 2017

Session Title: Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy Poster II: Prognostic Factors, Imaging and Miscellaneous Reports

Session Type: ACR Poster Session B

Session Time: 9:00AM-11:00AM

Background/Purpose:

Little is known regarding the corticosteroid sparing effect of non-TNF biologics in rheumatoid arthritis (RA).

Objectives : To compare the corticosteroid sparing effect of non-TNF biologics in daily practice in RA.

Methods:

Autoimmunity and Rituximab (AIR), Orencia and Rheumatoid arthritis (ORA) and REGistry–RoAcTEmra (REGATE) are three prospective registries promoted by the French Society of Rheumatology for patients who initiate rituximab (RTX), abatacept (ABA), or tocilizumab (TCZ), as intravenous drugs.

The observational data were used to emulate a target trial with 3 groups: patients receiving rituximab, abatacept and tocilizumab. A propensity-score approach was used to adjust for differences in observed factors that might affect both treatment assignment and outcome and to emulate randomization.

Change in oral corticosteroid dosage was analyzed by 3 different approaches regardless of drug discontinuation: delta decrease ≥ 5 mg/d compared to baseline dose, final daily dose ≤ 5 mg/d, and total discontinuation of corticosteroids in patients receiving the drug at baseline. To compare these outcomes, we used logistic regression with weighted GEEs, with drug as the only covariate.

Results:

At enrollment, 77.7, 74.4 and 66.5% of patients treated with RTX (n= 1619), ABA (n= 623) and TCZ (n= 941) had daily oral corticosteroid (mean (SD dose): 11.8 (8.8), 11.2 (8.3), 10.3 (7.2) mg/ day, respectively).

– Delta decrease ≥ 5 mg of the daily dose compared to enrollment

At 6 months, such a decrease was observed in 31.6, 41.6 and 48.4% of RTX, ABA and TCZ-treated patients respectively (p=0.003 for the comparison between TCZ and RTX, no significant difference between ABA and TCZ) . At 12 months, such a decrease was observed in 43.1, 51.9 and 62.2% of RTX, ABA and TCZ-treated patients respectively (p< 0.001 between TCZ and RTX). At 24 months, it was observed in 58.3, 62 and 71% of patients, respectively.

– Daily dose ≤ 5 mg/d

At 6 months, a daily dose ≤ 5 mg/d was observed in 26.4, 37.8 and 52.9% of patients, treated with RTX, ABA and TCZ respectively( p< 0.001 between TCZ and RTX). At 12 months, it was observed in 44.7, 53.5 and 72.2% of patients, respectively ( p< 0.001 between TCZ and RTX). At 24 months, a daily dose ≤ 5 mg/d was observed in 66.1, 67.1% and 75.8% of patients, respectively (p=0.001 between TCZ and RTX).

– Discontinuation of oral corticosteroids

At 6 months, in patients initially treated with steroids, oral corticosteroids were discontinued in 9.7, 13.7 and 15.6% of patients respectively treated with RTX, ABA and TCZ. At 12 months, they were discontinued in 11.5, 23.4 and 24.9% of patients, respectively (p= 0.003 between ABA and RTX, p< 0.001 between TCZ and RTX). At 24 months, steroids were discontinued in 20.5, 31.5 and 38% of patients, respectively.

Conclusion:

These results demonstrate a corticosteroid-sparing effect for all 3 of the non-TNF targeted biologics in around half of the patients at 12 months. However, only 21% to 38% of patients with baseline oral corticosteroids use could discontinue corticosteroids at 24 months, which emphasizes the need to continue to enlarge the armamentarium of new biologic and targeted DMARDs in RA.

Disclosure: J. E. Gottenberg, BMS, Gilead, Medimune,Pfzer SanofiAventis, Roche, Ucb, 2; J. Morel, None; A. Constantin, None; T. Bardin, None; A. Cantagrel, None; B. Combe, None; M. Dougados, AbbVie, Lilly, Merck, Novartis, Pfizer, Sanofi, and UCB., 2,AbbVie, Lilly, Merck, Novartis, Pfizer, Sanofi, and UCB., 5; R. M. Flipo, Chugai Pharma France, 5,Roche SAS, 5; A. Saraux, None; T. Schaeverbeke, None; J. Sibilia, None; M. Soubrier, None; O. Vittecoq, None; G. Baron, None; E. Perrodeau, None; P. Ravaud, None; X. Mariette, None.

To cite this abstract in AMA style:

Gottenberg JE, Morel J, Constantin A, Bardin T, Cantagrel A, Combe B, Dougados M, Flipo RM, Saraux A, Schaeverbeke T, Sibilia J, Soubrier M, Vittecoq O, Baron G, Perrodeau E, Ravaud P, Mariette X. Corticosteroid Sparing Effect of Non-TNF Targeted Biologics, Rituximab, Abatacept and Tocilizumab in Common Practice: Data from 3183 Patients Enrolled in the French Society of Rheumatology Registries [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/corticosteroid-sparing-effect-of-non-tnf-targeted-biologics-rituximab-abatacept-and-tocilizumab-in-common-practice-data-from-3183-patients-enrolled-in-the-french-society-of-rheumatology-registries/. Accessed November 13, 2019.

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