Infectious complications of bispecific antibody therapy in patients with multiple myeloma

We identified 39 MM patients who received BsAb therapy at our centre with median follow-up of 152 (IQR 51–277) days. The median age was 62 years (IQR 56–70), 24 (62%) were male and had received a median of 6 (IQR 4–7) prior lines of therapy. The majority of patients (38, 97%) had prior haematopoeitic stem cell transplant.

Patients completed a median of 5 (IQR 2–11) cycles of BsAb therapy and CRS occurred in 28 (72%) and ICANS in 2 (5%) patients. The median duration of neutropenia and lymphopenia <1.0 × 109/L was 1 (IQR 0–3) and 22 (13–61) days respectively. Hypogammaglobulinemia was documented in 34 (87%) patients, with immunoglobulin replacement in 18 (53%). Further details are summarised in Table 1.

Table 1 Baseline characteristics of the 39 MM patients on BsAb therapy.

Of the 39 patients, 35 (90%) had at least 1 episode of infection (MDI, CDI, FUF). A total of 15 (38%) had an MDI and 16 (41%) had at least one grade 3 or higher infection episode (Table 2).

Table 2 Characteristics and outcomes of infection episodes.

A total of 111 infection episodes occurred during the study period at a median of 2 (IQR 1–7) BsAb cycles. Median (IQR) nadir neutrophil and lymphocyte counts in the preceding fortnight were 1.8 (1.1–2.3) × 109/L and 0.3 (0.1–0.7)) × 109/L respectively. Prophylactic valaciclovir had been administered in 104 (94%), trimethoprim/sulfamethoxazole in 104 (94%) and antifungal prophylaxis (most commonly mould-active) in 38 (34%) infection episodes. Median cumulative prednisone-equivalent dose received by patients in the 30 days prior to infection was 266.7 mg (IQR 106.7–266.7).

Of the 111 infective episodes, 33 (30%) were MDI, 43 (39%) were CDI, and 35 (32%) were FUF (Table 2). The most common site of infection was the respiratory system (46, 41%) followed by gastrointestinal (8, 7%). Of the MDI, 22 (58%) viruses were isolated, 15 (39%) bacteria, and 1 (3%) acid-fast bacilli. Two organisms were isolated in 5 infective episodes. The most common viral infection was rhinovirus/enterovirus (8, 36%), followed by cytomegalovirus (4, 18%) and adenovirus (4, 18%). Majority of bacterial infections were associated with the gastrointestinal tract (Salmonella sp., Escherichia coli, Pseudomonas aeruginosa, Clostridium difficile, Enterococcus faecalis). There were no episodes of invasive fungal disease. MDI episodes occurred a median of 79 (IQR 29–289) days after BsAb commencement. Majority of FUF were likely CRS (31, 89%).

Sixty three (57%) infective episodes, in 30 patients, resulted in hospital admission with a median length of stay of 4 (3–7) days. Intensive care admission was required in 4 (4%) episodes and all-cause mortality was 3%. Patients required a median (IQR) of 5 (3–9) days of intravenous or oral antibiotics.

Baseline clinical variables age, functional status, international staging system stage, prior lines of therapy, number of BsAb cycles, CRS, and its treatment were not associated with increased risk for MDI on univariate analysis. Therefore multivariate logistic regression was not performed.

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