Prospective Follow-up of Tocilizumab Treatment in 764 Patients with Refractory Rheumatoid Arthritis: Tolerance and Efficacy Data From the French Registry Regate (REGistry –RoAcTEmra)

Jacques Morel¹, Marie-Odile Duzanski², Thomas Bardin³, Alain G. Cantagrel⁴, Bernard Combe⁵, Maxime Dougados⁶, Rene-Marc Flipo⁷, Jacques-Eric Gottenberg⁸, Xavier Mariette⁹, Martin Soubrier¹⁰, Olivier Vittecoq¹¹, Alain Saraux¹², Thierry Schaeverbeke¹³ and Jean Sibilia¹⁴, ¹Dpartment of Rheumatology, Lapeyronie Hospital, Montpellier, France, ²Service Pharmacie - Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg, Strasbourg, France, ³Rheumatology, Hôpital Lariboisière, Paris, France, ⁴Dept of Rheumatology, Centre Hospitalier Universitaire de Toulouse, Toulouse, France, ⁵Rheumatology, Hopital Lapeyronie, Montpellier, France, ⁶Rheumatology B Department, Paris-Descartes University, APHP, Cochin Hospital, Paris, France, ⁷Rheumatology, Hopital R Salengro CHRU, Lille, France, ⁸Rheumatology, Strasbourg University Hospital, Strasbourg, France, ⁹Rheumatology, Université Paris-Sud, Le Kremlin Bicetre, France, ¹⁰Rheumatology, CHU CLERMONT-FERRAND, Clermont-Ferrand, France, ¹¹Rheumatology, Rouen University Hospital & Inserm905, University of Rouen, Rouen Cedex, France, ¹²Rhumatologie, CHU de la Cavale Blanche, Brest Cedex, France, ¹³Service de Rhumatologie, Groupe Hospitalier Pellegrin, Bordeaux, France, ¹⁴Rhumatologie, CHU Hautepierre, Strasbourg, France

Meeting: 2012 ACR/ARHP Annual Meeting

Keywords: Rheumatoid arthritis (RA), tocilizumab and tolerance

Session Information

Title: Rheumatoid Arthritis - Clinical Aspects I: Drug Studies/Drug Safety/Drug Utilization/Disease Activity & Remission

Session Type: Abstract Submissions (ACR)

Background/Purpose: To assess tolerance and safety of rheumatoid arthritis (RA) treatment by tocilizumab (TCZ) in real life

Methods: The French Society of Rheumatology and the Club Rheumatism and Inflammation set up the REGATE registry to prospectively collect, every 6 months for 5 years, data from 1500 patients treated with TCZ for refractory rheumatoid arthritis.

Results:

From January 13^th 2011 to April 2^nd 2012, RA patients treated by TCZ initiated after January 1^st2010 have been prospectively included from 76 French centres in the REGATE registry. Among the 764 included patients (women: 80.1%, mean age 57.2±13.4 years, mean disease duration: 14.1 years (9.57), mean number of prior DMARD: 2.6 (±1.6), 76.3% RF-positive, 77.9% ACPA positive), 5.4% of patients had a history of cancer and 6.15% of severe infection, 19.1% of cardiovascular events and 24.2% of dyslipidemia before TCZ. 16.2% had not received any anti-TNF prior to TCZ and the mean number of biologics before TCZ was 2.1±1.5. The last biologic prescribed before initiation of TCZ was an anti-TNF for 59.1% of patients, rituximab for 17.7%, abatacept for 22.2% and others (kineret, ocrelizumab) for 1%. The median time between the last dose of the previous biologic and the first infusion of TCZ was 1.83 months (0-120).

Before TCZ, mean DAS28 was 5.18±1.3. 68.7% of the patients received corticosteroids with a mean dose of 12.93 ± 41.4 mg/day. 38.3% of patients were treated with TCZ as monotherapy, and 61.7% with a concomitant DMARD mainly methotrexate (83%). After 1.3 years, the drug was stopped for 79 patients: 39 of them (51.9%) for non response and in 33 of them (44%) for safety reasons. 440 patients have already had at least 1 follow-up visit with mean current follow-up duration of 7.5 (±4.6) months corresponding to an exposure of 274 patients/year (PY). Ten patients discontinued TCZ for infusion-reactions (2.3%).. Twenty two severe infections (11 soft tissues, 4 gastrointestinal, 3 articular, 3 respiratory tract and 1 genital) were reported in 20 patients corresponding to a rate of severe infections of 8.0/100 PY. The other SAE were 3 gut perforations (1/100 PY), 2 lymphoma (0.7/100 PY), 1 skin cancer (0.36 /100 PY), but no cardiovascular event and death were recorded.

Conclusion: These first and preliminary results of the REGATE registry show that a high proportion of patients treated with TCZ was previously treated by anti-TNF (87%) even though it can be prescribed as a first line biologic. In addition, TCZ is not infrequently prescribed in monotherapy in clinical practice (38%). Severe infections are in the higher range observed with biologics but deserve to be confirmed after longer exposure duration.

Disclosure:

J. Morel,

Roche CHUGAI,

Roche Pharmaceuticals,

Bristol-Myers Squibb,

UCB,

Pfizer Inc,

Abbott Laboratories,

Merck Pharmaceuticals,

Amgen,

M. O. Duzanski,
None;

T. Bardin,
None;

A. G. Cantagrel,

Chugai, BMS, Roche, UCB, Abbott, Pfizer,

UCB, Pfizer,

B. Combe,
None;

M. Dougados,
None;

R. M. Flipo,
None;

J. E. Gottenberg,
None;

X. Mariette,
None;

M. Soubrier,
None;

O. Vittecoq,
None;

A. Saraux,
None;

T. Schaeverbeke,
None;

J. Sibilia,
None.

« Back to 2012 ACR/ARHP Annual Meeting

ACR Meeting Abstracts - https://acrabstracts.org/abstract/prospective-follow-up-of-tocilizumab-treatment-in-764-patients-with-refractory-rheumatoid-arthritis-tolerance-and-efficacy-data-from-the-french-registry-regate-registry-roactemra/