Safety Results
treatment-related, injection-site reactions, eyelid edema, swelling, upper respiratory tract infection, TEAEs, Treatment-emergent adverse, optic neuritis, pruritus, eyelid ptosis, urticaria chronica, eczema
UPPER RESPIRATORY TRACT INFECTIONS, EYELID EDEMA, HYPERSENSITIVITY REACTION, INVASIVE BREAST CARCINOMA, OPTIC NEURITIS, URTICARIA CHRONIC, EYELID PTOSIS, ECZEMA
No new safety signals for aboBoNT-A were reported in this study. The proportion of patients who experienced at least one TEAE during the double-blind cycle was similar between aboBoNT-A and active comparator treatment groups (46.6% and 44.9%, respectively), and the most frequently reported TEAEs were upper respiratory tract infection (URTI; 8.9% and 11.2%, respectively) and viral URTI (4.6% and 3.7%, respectively) (Table Treatment-emergent adverse eventsData are shown for all randomized patients who received aboBoNT-A 50 U in at least one injection site regardless of the amount administered (safety population). In the open-label period, there was a trend toward a decreased incidence of TEAEs and treatment-related TEAEs with repeated cycles of aboBoNT-A 50 U received over a total treatment duration of 15 months. The incidence of treatment-related eyelid ptosis (1.9%, 1.6%, 0.4%, and 0% of patients in cycles 2, 3, 4, and 5, respectively) and eyelid edema (0.6%, 0.5%, 0.0%, and 1.0% of patients in cycles 2, 3, 4, and 5, respectively) decreased overall with repeated treatment of aboBoNT-A.During cycle 1, two patients (1.9%) withdrew from the active comparator group (one case of mild eyelid ptosis [non-serious, treatment-related TEAE] and one case of mild eczema [non-serious, unrelated TEAE]). During the open-label phase, two patients (0.4%) treated with aboBoNT-A 50 U withdrew as a result of TEAEs, both unrelated to study treatment (one case of invasive breast carcinoma [serious; cycle 2], and one case of optic neuritis [non-serious; cycle 3]).No TEAEs suggestive of remote spread of toxin effects were identified during the study. One patient experienced swelling of the face suggestive of a hypersensitivity reaction in cycle 1, which may have been confounded by concomitant urticaria chronica. The majority of injection-site reactions occurred during cycle 1, the most common being injection-site pruritus (four patients [1.2%] in the aboBoNT-A group and two patients [1.9%] in the active comparator group), with the incidence decreasing after subsequent treatment cycles with aboBoNT-A. The majority of injection-site reactions occurred on the day of injection or the day following injection and resolved quickly within 1–3 weeks.No patient showed a seroconversion for binding antibodies or neutralizing antibodies to BoNT-A during the study. Both binding and neutralizing antibodies were detected at baseline in one patient who received aboBoNT-A 50 U; the patient tested negative at cycle 1, day 85, and then positive again at end of study for binding and neutralizing antibodies. The latter finding was unexpected but was not considered to be related to administration of the active product.