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Abstract Number: 744

Relationship Between Infectious Side Effects and Immunoglobulin Levels In The Maintenance Rituximab Vs Azathioprine For ANCA-Associated Vasculitides Trial

Loic Guillevin1, Christian Pagnoux2, Alexandre Karras3, Chahera Khouatra4, Olivier Aumaître5, Pascal Cohen6, Olivier Decaux7, Hélène Desmurs-Clavel8, Pierre Gobert9, Thomas Quemeneur10, Claire Blanchard-Delaunay11, Pascal Godmer12, Xavier Puechal13, Pierre-Louis Carron14, Pierre-Yves Hatron15, Nicolas Limal16, Mohamed Hamidou17, Francois Maurier18, Thomas Papo19, Matthias Büchler20, Bernard Bonnotte21, Philippe Ravaud22 and Luc Mouthon23, 1Internal Medicine, Division of Internal Medicine, Hôpital Cochin, University Paris Descartes, Paris, France, 2Internal Medicine, Hôpital Cochin, PARIS, France, 3Nephrology, Hôpital Européen Georges Pompidou, APHP, Paris, France, 4CHU Lyon, Lyon, France, 5Division of internal Medicine, Centre Hospitalier Universitaire, Hôpital Gabriel Montpied, Clermont–Ferrand, Clermont–Ferrand, France, 6National Referral Center for Rare Systemic Autoimmune Diseases, Hôpital Cochin, AP–HP, Université Paris Descartes, Paris, Paris, France, 7Department of Internal Medicine, Rennes University Hospital, Rennes, France, 8University of Lyon, LYON, France, 9Nephrology, Centre Hospitalier d'Avignon, Avignon, France, 10Internal medicine, CHR de Valenciennes, Valenciennes, France, 11Internal Medicine, Hôpital de Niort, Niort, France, 12Department of Internal Medicine, Centre Hospitalier Bretagne Atlantique de Vannes, Vannes, France, 13Department of Internal Medicine, Referral Center for Rare Autoimmune and Systemic Diseases, Hôpital Cochin, AP–HP, Université Paris Descartes, Paris, France, 14Internal Medicine, Centre Hospitalier de Grenoble, Grenoble, France, 15Department of Internal Medicine, Claude Huriez University Hospital, Lille, France, 16Department of Internal Medicine, Hôpital Henri Mondor, APHP, Creteil, France, 17Internal Medicine Department, Nantes University Hospital, Nantes, France, 18HP Metz Belle Isle Hospital, Department of Internal Medicine, Metz, France, 19Internal Medicine, University Paris-7, INSERM U699, APHP, Bichat Hospital, Paris, France, 20Nephrology, University Hospital of Tours, TOURS, France, 21Department of Internal Medicine, Centre Hospitalier de Dijon, Dijon, France, 22Epidemiology, Hopital Hotel Dieu, Paris Descartes University, Paris, France, 23Department of Internal Medicine, Referral Center for Rare Autoimmune and Systemic Diseases, Hôpital Cochin, AP–HP, Université Paris Descartes, Paris, France, Paris, France

Meeting: 2013 ACR/ARHP Annual Meeting

Keywords: azathioprine, Infection, rituximab and vasculitis

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Session Information

Session Title: Vasculitis I

Session Type: Abstract Submissions (ACR)

Background/Purpose: MAINRITSAN trial (NCT 00748644) results demonstrated that 500 mg of rituximab (RTX) every 6 months was superior to azathioprine (AZA) to maintain ANCA-associated–vasculitis (AAV) remission. Infection frequencies were comparable in the 2 arms, and other SAE were infrequent and resolved in most patients. This study aimed to determine whether globulin levels could be associated with infectious side effects .


Methods: Once remission was obtained with a conventional regimen, patients with newly diagnosed or relapsing AAV were randomly assigned to receive a 500-mg RTX infusion on D1, D15, 5.5 months later, then every 6 months for a total of 5 infusions over 18 months, or AZA (initial dose 2 mg/kg/d) for 22 months. The primary endpoint was the major relapse rate (EULAR/ACR criteria) at 28 months. Other outcome measures were the severe adverse event (SAE) rate (WHO definition) associated with each maintenance regimen. Infectious SAE occurring in both groups were one of the study’s secondary endpoints, as were gammaglobulin, IgG and IgM levels (1/3 missing data for valid reasons).

Results:

Among the 115 patients (50 men/65 women; mean age, 55±13 years; 92 newly diagnosed and 23 relapsers) study participants (57 RTX arm, 58 AZA arm): 87 had granulomatosis with polyangiitis, 23 microscopic polyangiitis and 5 kidney-limited diseases. The main clinical involvements at diagnosis or last relapse were: 89 (77.4%) ENT, 71 (61.7%) lung and 81 (70.4%) kidney. Major relapses occurred in 20 (17.3%) patients: 3 (3.5%) in the RTX arm and 17 (29.3%) in the AZA arm, with 3 AZA-arm deaths (1 sepsis, 1 pancreatic cancer, 1 mesenteric ischemia). Seven infectious SAE (12.2%) were recorded in the RTX arm and 8 (13.7%) in the AZA arm (Table). Respective RTX- and AZA-arm mean levels (g) of gammaglobulin were: 8.04 (±6.05) and 7.21 (±2.18) at M0, and 7.41 (±2.16) and 8.1 (±2.89) at M28; IgG were 6.06 (±2.66) and 5.44 (±1.58) at M0, and 6.87 (±2.50) in the RTX arm and 6.71 (±1.05) at M28; IgM were 0.64 (± 0.5) and 0.58 (± 0.51) at M0, and 0.44 (±0.62) and 0.6 (±0.32) at M28.

 

Infection

RTX 57 patients

AZA 58 patients

Bronchitis

2

0

Tuberculosis

1

0

Bacterial pneumonia

0

1

Pneumocystis jiroveci pneumonia

1

0

Bacterial endocarditis

0

1

Mycobacterial infection

0

1

Prostatitis

0

1

Herpes zoster

1

1

Angiocholitis

0

1

Septicemia

0

1 (died)

Esophageal candidiasis

1

0

Campylobacter jejuni diarrhea

1

1

Conclusion: These trial results demonstrated that 500 mg of RTX every 6 months was not only superior to AZA to maintain AAV remission but as safe as AZA. At the chosen dose, RTX did not significantly decrease gammaglobulin, IgG and IgM levels. The rare infections, observed in both groups, were reflected causes and mechanisms other than Ig levels.


Disclosure:

L. Guillevin,

Roche Pharmaceuticals,

9;

C. Pagnoux,

Roche Pharmaceuticals,

9;

A. Karras,
None;

C. Khouatra,
None;

O. Aumaître,
None;

P. Cohen,
None;

O. Decaux,
None;

H. Desmurs-Clavel,
None;

P. Gobert,
None;

T. Quemeneur,
None;

C. Blanchard-Delaunay,
None;

P. Godmer,
None;

X. Puechal,
None;

P. L. Carron,
None;

P. Y. Hatron,
None;

N. Limal,
None;

M. Hamidou,
None;

F. Maurier,
None;

T. Papo,
None;

M. Büchler,
None;

B. Bonnotte,
None;

P. Ravaud,
None;

L. Mouthon,
None.

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