Serum sickness secondary to treatment with the murine-human chimeric antibody IDEC-C2B8 (rituximab)

D'Arcy, Christopher A.; Mannik, Mart

doi:10.1002/1529-0131(200107)44:7<1717::aid-art299>3.0.co;2-c

Cited by 86 publications

(53 citation statements)

References 5 publications

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“…Three patients developed serum sickness-like symptoms, with HACAs. Only 6 cases of serum sickness after rituximab treatment have been reported to date in the literature (23,(34)(35)(36), including 1 case in a patient with primary SS and associated MALT-type lymphoma (23). Most of the toxicities associated with rituximab are infusion related, presumably due to cytokine release (37).…”

Section: Discussionmentioning

confidence: 99%

Rituximab treatment in patients with primary Sjögren's syndrome: An open‐label phase II study

Pijpe

Imhoff²,

Spijkervet

et al. 2005

Arthritis & Rheumatism

448

300

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Objective. To investigate the safety and efficacy of B cell depletion treatment of patients with active primary Sjögren's syndrome of short duration (early primary SS) and patients with primary SS and mucosaassociated lymphoid tissue (MALT)-type lymphoma (MALT/primary SS).Methods. Fifteen patients with primary SS were included in this phase II trial. Inclusion criteria for the early primary SS group were B cell hyperactivity (IgG >15 gm/liter), presence of autoantibodies (IgM rheumatoid factor, anti-SSA/SSB), and short disease duration (<4 years). Inclusion criteria for the MALT/ primary SS group were primary SS and an associated MALT-type lymphoma (Ann Arbor stage IE) localized in the parotid gland. Patients were treated with 4 infusions of rituximab (375 mg/m 2 ) given weekly after pretreatment with prednisone (25 mg) and clemastine. Patients were evaluated, using immunologic, salivary/ lacrimal function, and subjective parameters, at baseline and at 5 and 12 weeks after the first infusion.Results. Significant improvement of subjective symptoms and an increase in salivary gland function was observed in patients with residual salivary gland function. Immunologic analysis showed a rapid decrease of peripheral B cells and stable levels of IgG. Human antichimeric antibodies (HACAs) developed in 4 of 15 patients (27%), all with early primary SS. Three of these patients developed a serum sickness-like disorder. Of the 7 patients with MALT/primary SS, complete remission was achieved in 3, and disease was stable in 3 and progressive in 1.Conclusion. Findings of this phase II study suggest that rituximab is effective in the treatment of primary SS. The high incidence of HACAs and associated side effects observed in this study needs further evaluation.

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Section: Discussionmentioning

confidence: 99%

Rituximab treatment in patients with primary Sjögren's syndrome: An open‐label phase II study

Pijpe

Imhoff²,

Spijkervet

et al. 2005

Arthritis & Rheumatism

448

300

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“…Anti-drug antibodies (ADA) have been implicated in infusion reactions and anaphylaxis (6,7) as well as immune complex-mediated diseases (8,9). ADA have also caused secondary treatment failures (loss of efficacy) (10)(11)(12) and, in rare occasions, more serious adverse events such as deficiency syndromes for instance thrombocytopenia and pure red cell aplasia (13,14).…”

Section: Introductionmentioning

confidence: 99%

Assessment and Reporting of the Clinical Immunogenicity of Therapeutic Proteins and Peptides—Harmonized Terminology and Tactical Recommendations

Shankar

Arkin

Cocea

et al. 2014

AAPS J

260

264

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Abstract. Immunogenicity is a significant concern for biologic drugs as it can affect both safety and efficacy. To date, the descriptions of product immunogenicity have varied not only due to different degrees of understanding of product immunogenicity at the time of licensing but also due to an evolving lexicon that has generated some confusion in the field. In recent years, there has been growing consensus regarding the data needed to assess product immunogenicity. Harmonization of the strategy for the elucidation of product immunogenicity by drug developers, as well as the use of defined common terminology, can benefit medical practitioners, health regulatory agencies, and ultimately the patients. Clearly, understanding the incidence, kinetics and magnitude of anti-drug antibody (ADA), its neutralizing ability, cross-reactivity with endogenous molecules or other marketed biologic drugs, and related clinical impact may enhance clinical management of patients treated with biologic drugs. To that end, the authors present terms and definitions for describing and analyzing clinical immunogenicity data and suggest approaches to data presentation, emphasizing associations of ADA development with pharmacokinetics, efficacy, and safety that are necessary to assess the clinical relevance of immunogenicity.

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“…Other chimeric molecules used to treat various conditions, such as abciximab for acute coronary syndromes, trastuzumab for breast cancer, and rituximab for certain lymphomas, contain components that are candidates to produce serum sickness-like reactions as well (20). Although data are limited for most monoclonal antibodies, it is reasonable to expect that murine monoclonal antibodies would be more likely to be associated with serum sickness-like reactions than humanized or human monoclonal antibodies.…”

Section: Discussionmentioning

confidence: 99%

Serum sickness-like reactions in patients receiving intravenous infliximab

Gamarra

McGraw

Drelichman

et al. 2006

The Journal of Emergency Medicine

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Serum sickness secondary to treatment with the murine-human chimeric antibody IDEC-C2B8 (rituximab)

Cited by 86 publications

References 5 publications

Rituximab treatment in patients with primary Sjögren's syndrome: An open‐label phase II study

Rituximab treatment in patients with primary Sjögren's syndrome: An open‐label phase II study

Assessment and Reporting of the Clinical Immunogenicity of Therapeutic Proteins and Peptides—Harmonized Terminology and Tactical Recommendations

Serum sickness-like reactions in patients receiving intravenous infliximab

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