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Abstract Details

Characterization of Antibiotic Prophylaxis Risk Mitigation Practices Across Eculizumab and Ravulizumab Adult, Phase III Clinical Trials for Paroxysmal Nocturnal Hemoglobinuria, Atypical Hemolytic Uremic Syndrome, Generalized Myasthenia Gravis, and Neuromyelitis Optica Spectrum Disorder
Autoimmune Neurology
P2 - Poster Session 02 (3:00 PM-4:00 PM)
1-056
To describe the antibiotic prophylaxis (AB-PPx) durations of exposure and classes by indication in Alexion C5 inhibitor therapies (ALXN-C5ITs) adult pivotal studies.

ALXN-C5ITs, eculizumab and ravulizumab, are indicated for paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), generalized myasthenia gravis (gMG), and neuromyelitis optica spectrum disorder (NMOSD). As with inherited complement deficiencies, ALXN-C5ITs carry risk for Neisseria meningitidis infection and AB-PPx is advised in patients not up to date with vaccinations. Data gaps exist, however, in AB-PPx drug selection and duration for ALXN-C5IT patients.
ALXN-C5IT–exposed patients during PNH, aHUS, gMG, or NMOSD adult trials who received at least 1 dose of AB-PPx against meningococcal infection were included. AB-PPx patterns were stratified by geography and indication for ALXN-C5IT–exposed patients. Demographics, frequencies of AB-PPx durations, and classes utilized were calculated with descriptive statistics.
The 946 patients enrolled were primarily White (58.7%), female (59%), and on ALXN-C5IT for a mean of 2.81±1.52 years (y). Overall, 38.3% (362/946) received AB-PPx, notably in Europe (64.9%, 235/362), Asia-Pacific (59/362, 16.3%), and the U.S. (32/362, 8.8%). AB-PPx was most utilized in PNH (210/362, 58%), then aHUS (122/362, 33.7%), NMOSD (18/362, 5%), and gMG (12/362, 3.3%). Among U.S. patients, 65.6% (21/32) received AB-PPx ≤30 days, whereas 53% (175/330) of ex-U.S. patients received AB-PPx >1y. Among the AB-PPx classes investigated, penicillins were most used (U.S.: 43.8%; ex-U.S.: 66.4%).
AB-PPx durations varied at ALXN-C5IT initiation, with the majority of patients receiving either 1-30 days (U.S.) or >1y (ex-U.S.). Penicillin-class AB-PPx was most utilized, regardless of geography, consistent with inherited-complement-deficiency recommendations.
Authors/Disclosures
Ukwen Akpoji, PharmD (Alexion, AstraZeneca Rare Disease)
PRESENTER 		Dr. Akpoji has received personal compensation for serving as an employee of Alexion, AstraZeneca Rare Disease. Dr. Akpoji has or had stock in Alexion, AstraZeneca Rare Disease.
Shirali Pandya, PhD (Alexion Pharmaceuticals) Dr. Pandya has received personal compensation for serving as an employee of Alexion, Astra Zeneca Rare Disease. Dr. Pandya has received personal compensation for serving as an employee of Rhythm Pharmaceuticals. Dr. Pandya has stock in Sanofi. Dr. Pandya has stock in Alexion, Astra Zeneca Rare Disease.
Rasha Aguzzi (Alexion) Rasha Aguzzi has received personal compensation for serving as an employee of Alexion Pharmaceutical. Rasha Aguzzi has or had stock in AstraZeneca.
Jeannette Stankowski, PhD (Alexion) Dr. Stankowski has nothing to disclose.
Sami Fam Sami Fam has received personal compensation for serving as an employee of Alexion Pharmaceuticals. Sami Fam has or had stock in Astra Zeneca.
Arshad Mujeebuddin, MBBS Dr. Mujeebuddin has received personal compensation for serving as an employee of Alexion AstraZeneca Rare Disease. Dr. Mujeebuddin has stock in AstraZeneca.
Lokesh Jha, MD Dr. Jha has received personal compensation for serving as an employee of Alexion Pharmaceuticals. Dr. Jha has or had stock in Alexion Pharmaceuticals.