Safety outcomes.
bleeding, nausea, polyarthritis, WHIM syndrome, friable, psoriasis, weight gain, hyperuricemia, headache, arthralgia
BLEEDING, RECURRENCE, TRANSIENT ISCHEMIC ATTACK, ADVERSE EVENTS, POLYARTHRITIS, MINOR, WHIM SYNDROME, PSORIASIS, HYPERURICEMIA, INJECTION SITE REACTION, EVENTS, URETHRA
Seven serious adverse events (SAEs) occurred among 6 patients, 1 during the open-label G-CSF posttreatment phase and 6 during a treatment phase (1 during plerixafor treatment only, 4 during G-CSF treatment only, and 1 during both plerixafor and G-CSF treatment) (A sixth SAE that was unanticipated and probably related to both study drugs was new onset reactive additive polyarthritis occurring in the wrists, hands, and knees of patient M14 on both plerixafor and G-CSF. He first noticed mild arthralgia in his hands 10 days after beginning open-label G-CSF during the screening phase. After starting plerixafor as study drug number 1, symptoms intensified and spread to involve the other joints. Plerixafor was stopped after 18 days. Workup revealed a friable urethra that was painful on gentle dacron swabbing, with bleeding and a yellowish discharge. One unanticipated noninfectious SAE occurred on G-CSF and was judged unrelated to the drug: a transient ischemic attack in patient M05 during outpatient gynecologic surgery. There was no prior history of cerebrovascular events, and she has had no recurrence through June 2023.Another 207 noninfectious adverse events in 58 descriptor categories occurred during the trial (an average of 0.33 versus 0.40 noninfectious adverse events/patient-month on G-CSF versus plerixafor, respectively) (Patient M09, who had a family history of psoriasis, dropped out during the plerixafor equilibration phase because of extensive new onset psoriasis. The lesions completely resolved when plerixafor was discontinued and after a short course of topical corticosteroids and did not flare during treatment with G-CSF, which was given second. She subsequently experienced one other psoriasis flare over 5 years since the end-of-study visit, during a phase II clinical trial for WHIM syndrome of the chemically distinct small-molecule CXCR4 antagonist mavorixafor (A second group of less frequent, transient, and tolerated grade 1 or 2 adverse events that were considered probably or possibly related to a study drug and were not significantly different in frequency on the 2 drugs included headache in 9 patients, hyperuricemia in 7 patients, weight gain in 7 patients, nausea in 7 patients, and injection site reactions in 4 patients. The remaining adverse events were transient minor laboratory abnormalities or were mild and affected only a few patients.