Safety
HYPOALBUMINEMIA, EVENT, ADVERSE EVENT
Batoclimab was generally well tolerated throughout the study. The frequencies of patients experiencing any AEs and treatment‐related AEs (TRAEs) were well balanced between treatment arms, including the placebo arm, in the double‐blind phase (Table Safety profile.AE, adverse event; OLE, open‐label extension; q2w, once every 2 weeks; qw, once weekly; RBC, red blood cell; TRAE, treatment‐related AE.
Grade 3 Worsening of MG in a patient who received placebo in the double‐blind period and batoclimab 340 mg q2w in the OLE. The patient discontinued early from the OLE follow‐up (Week 16). The event was considered unrelated to therapy.One patient experienced a serious AE of During the follow‐up phase, a serious AE (worsening of MG) leading to early study discontinuation was reported in a patient who received placebo during the double‐blind phase and batoclimab 340 mg every 2 weeks during the OLE; the patient was hospitalized, and the event resolved. This event was considered unrelated to study drug.Reductions in serum albumin were observed during the study, with maximum mean reductions from baseline observed at Week 4 in the batoclimab 680‐mg group (mean [±SD] concentration, 31.6 [±3.1] g/L; mean [SD] change from baseline, −12.0 [±2.6] g/L) and at Week 5 in the 340‐mg group (mean [±SD] concentration, 35.2 [±1.3] g/L; mean [SD] change from baseline, −11.2 [±3.4] g/L). Low albumin concentrations (defined as <32 g/L) were observed in 4 out of 11 patients receiving batoclimab (all in the 680‐mg group) during the double‐blind phase, including 2 patients with nadirs of 27 g/L. At the end of the follow‐up period (i.e., 6 weeks after the last dose of batoclimab), mean albumin concentrations returned back toward baseline levels. No patients had an AE related to hypoalbuminemia.The impact of batoclimab treatment on lipids was examined in a post hoc analysis using a limited number of available samples. Results indicated a dose‐dependent increase in total cholesterol, LDL‐C, and HDL‐C, with greater increases observed in patients receiving batoclimab 680 mg. In all instances, the lipid values in patients who had received batoclimab in the double‐blind treatment period returned to baseline values by the end of the follow‐up period at Week 17. While interpretation of these results is limited, given that data were only available for 1 or 2 patients at many timepoints, the findings are consistent with other studies of batoclimab.