- Due to its mechanism of action, eculizumab (Soliris) may increase the risk for life-threatening disseminated gonococcal infection (DGI).
Why this matters
- Remain vigilant for meningococcal and DGI among patients receiving eculizumab.
- Familiarity with/adherence to CDC guidelines for gonorrhea screening, patient education on heightened severe infection risk is essential.
- Include DGI in differentials of patients on eculizumab presenting with gram-negative diplococcal infections (especially with skin, joint involvement).
- Avoid macrolide prophylaxis if possible.
- 9 FDA Adverse Event Reporting System pre-, postmarketing Neisseria gonorrhoeae (N gonorrhoeae) infection safety reports.
- 89% (8/9) were classified as disseminated; all were hospitalized.
- 87.5% (7/8) had positive blood culture, 1 with positive cervical culture, subsequent joint pain, and DGI diagnosis, leading to mortality.
- 2 patients had septic shock, requiring vasopressors during acute period of illness.
- 3/6 patients were on concomitant antibiotic prophylaxis; definitive antibiotics for N gonorrhoeae included: ceftriaxone (n=4), azithromycin (n=2), meropenem (n=1), and ciprofloxacin (n=1).
- Case series describing N gonorrhoeae infection among patients receiving eculizumab, particularly among those progressing to DGI.
- Funding: FDA, CDC.
- Database inconsistencies.
- Reporting bias.
- Small case numbers.
- Majority of cases under age 25 years, increasing baseline risk regardless of eculizumab therapy.