Long-term efficacy and safety of pre-emptive maintenance therapy with rituximab in granulomatosis with polyangiitis: results from a single centre

Rituximab (RTX) is an anti-CD20 antibody used successfully in granulomatosis with polyangiitis (GPA) for induction and maintenance of remission. Our study aims to evaluate the long-term efficacy and safety of chronic pre-emptive RTX therapy in GPA. Retrospective study of 35 GPA patients treated with...

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Bibliographic Details
Published in:Rheumatology (Oxford, England) England), 2013-11, Vol.52 (11), p.2041-2047
Main Authors: Besada, Emilio, Koldingsnes, Wenche, Nossent, Johannes C
Format: Article
Language:English
Subjects:
Adolescent
Adult
Aged
Antibodies, Monoclonal, Murine-Derived - administration & dosage
Antibodies, Monoclonal, Murine-Derived - adverse effects
Antibodies, Monoclonal, Murine-Derived - therapeutic use
CD4 Lymphocyte Count
Clinical medical disciplines: 750
Drug Administration Schedule
Drug Evaluation - methods
Female
Granulomatosis with Polyangiitis - complications
Granulomatosis with Polyangiitis - drug therapy
Granulomatosis with Polyangiitis - immunology
Humans
Immunocompromised Host
Immunosuppressive Agents - administration & dosage
Immunosuppressive Agents - adverse effects
Immunosuppressive Agents - therapeutic use
Klinisk medisinske fag: 750
Male
Medical disciplines: 700
Medisinske Fag: 700
Middle Aged
Opportunistic Infections - complications
Opportunistic Infections - immunology
Remission Induction
Retrospective Studies
Reumatologi: 759
Rheumatology: 759
Risk Factors
Rituximab
Treatment Outcome
Vaskulitt
VDP
Young Adult
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Summary:Rituximab (RTX) is an anti-CD20 antibody used successfully in granulomatosis with polyangiitis (GPA) for induction and maintenance of remission. Our study aims to evaluate the long-term efficacy and safety of chronic pre-emptive RTX therapy in GPA. Retrospective study of 35 GPA patients treated with RTX between April 2004 and September 2011 for active disease and maintenance. RTX was initiated as two 1 g infusions 2 weeks apart and thereafter 2 g of RTX was readministered annually. Patients were followed for 47 (2-88) months. They received a median RTX dose of 8 g (2-13) over 5 (1-10) rounds. All patients had a clinical response, but nine relapses were recorded (flare rate of 6.6/100 patient-years). At last visit, 13 patients (37%) had discontinued RTX mainly due to hypogammaglobulinaemia (57%). Nine patients (26%) had severe infections (infection rate of 6.6/100 patient-years) and 10 patients (29%) had chronic infections. Risks factors for severe infections are a high cumulative dose of CYC, low CD4 cell count and a significant drop in total immunoglobulins after the first RTX round. Risks factors for chronic infections are low IgG level during RTX maintenance and possibly the cumulative RTX dose. Long-term pre-emptive RTX maintenance was efficacious in reducing the risk for relapse but was discontinued in one-third of the patients. The patients' net state of immunodeficiency under RTX changes over time as low immunoglobulin serum levels increased the risk for infections.
ISSN:1462-0324
1462-0332
DOI:10.1093/rheumatology/ket257