Maintenance with rituximab is safe and not associated with severe or uncommon infections in patients with follicular lymphoma: results from the phase IIIb MAXIMA study

Abstract

Previous randomized trials have demonstrated that rituximab maintenance (R-maintenance) can prolong time to progressive disease in patients with follicular lymphoma (FL). The phase IIIb MAXIMA study (NCT00430352) was a large prospective evaluation of R-maintenance in a daily care setting. The primary objective was safety. Secondary objectives included progression-free survival, overall survival, time to next lymphoma treatment, and partial response (PR) to complete response/unconfirmed (CR/CRu) conversion rate. Patients (n = 545) with first-line or relapsed FL who responded to 8 cycles of rituximab-based induction received R-maintenance every 2 months for 2 years. At study entry, 380 patients had CR or CRu, and 165 had PR. The median age was 57.0 years. The most common non-hematologic adverse events (AEs, excluding infusion-related reactions) were cough (9.9 % of patients), fatigue (7.5 %), nasopharyngitis (7.1 %), back pain (6.5 %), diarrhea (6.9 %), arthralgia (6.0 %), headache and hypertension (5.2 % each), and pyrexia (5.1 %). The majority of AEs were grade 1 or 2. Grade 3, 4, and 5 infections occurred in 21 (3.9 %), 2 (0.4 %), and 1 (0.2 %) patient, respectively. Fifty-one hematologic AEs occurred in 6.6 % (n = 35) of patients. Grade 3/4 prolonged neutropenia and hypogammaglobulinemia occurred in 13 (2.4 %) and 5 (0.9 %) patients, respectively. All cases of prolonged neutropenia or hypogammaglobulinemia were manageable and resolved. Fast infusion did not alter the safety profile. Efficacy was comparable with results from previous trials. R-maintenance is safe in a daily care setting for patients with first-line or relapsed FL.

Infection risks of rituximab versus non‐rituximab treatment for rheumatoid arthritis: A systematic review and meta‐analysis

“…The use of RTX may further increase chances of infection risks due to its immune suppressive effect . Although there are several studies addressing the infection issue when using RTX in patients with RA, there is still controversy about an increased risk of serious infections in RA patients treated with RTX . This question is even more complicated when we assess patients with RA who have already received other biologic DMARDs such as tumor necrosis factor inhibitors (TNFi), since TNFi alone can increase infection risk in RA patients .…”

Action and resistance of monoclonal CD20 antibodies therapy in B-cell Non-Hodgkin Lymphomas

“…The amount of circulating immunoglobulin (Ig) may decrease after the treatment with rituximab. Almost every hypogammaglobulinemia case has been described to be manageable and to do not produce severe associated infections [3].…”

“…The amount of circulating immunoglobulin (Ig) may decrease after the treatment with rituximab. Almost every hypogammaglobulinemia case has been described to be manageable and to do not produce severe associated infections [3].There are evidences of multiple mechanisms of action of rituximab, some of them involved in drugs' effect in the patients, although this still remains unclear, in part due to the lack of in vivo studies. After rituximab binding to its target, CD20, there are three main mechanisms of action: antibody-dependent cell-mediated cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC) and induction of apoptosis [4] (see Table 1).…”

Rituximab Maintenance Strategy in Advanced Follicular Lymphoma: Facts and Controversies

“…Also, the incidence of transformation to aggressive diff use large B cell lymphoma did not diff er between the groups and no other safety risks were observed 38 . Safety of rituximab maintenance treatment was investigated in MAXIMA, a phase IIIb trial, including 545 patients with previously untreated or relapsed FL 50 . Hematologic adverse events equal and greater than 3 occurred in 4.4% of subjects with the most prominent event being neutropenia (2.4%), but only 4 cases of febrile neutropenia were recorded.…”