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Evaluation and prevention of infections associated with C1s and C3 complement inhibitors

Evaluation and prevention of infections associated with C1s and C3 complement inhibitors
Medication Associated infections* Pre-treatment management Medical prophylaxis

Pegcetacoplan
(C3 inhibitor)

Sutimlimab
(C1s inhibitor)		 Serious infections due to encapsulated bacteria:
  • Neisseria meningitidis (any serogroup, including nongroupable strains)
  • Streptococcus pneumoniae
  • Haemophilus influenzae type b
  • Meningococcal vaccination (against serotypes A, B, C, W, and Y): Complete primary vaccine series or administer booster vaccine (if indicated) at least 2 weeks prior to starting treatment, unless the risk of delaying treatment outweighs the risk of developing meningococcal disease
  • Pneumococcal vaccination: Administer pneumococcal vaccine (as indicated for patients at high risk of disease) at least 2 weeks prior to starting treatment, unless the risk of delaying treatment outweighs the risk of developing pneumococcal disease¶Δ
  • Update all routine age-appropriate vaccinations (especially Hib) before initiating C5 inhibitor or once the patient is clinically stable if treatment is needed urgently◊
  • Ensure control/resolution of any serious active infections with an encapsulated bacteria (eg, N. meningitidis) prior to initiating therapy

If meningococcal and/or pneumococcal vaccination is not completed 2 weeks prior to initiating a C1s or C3 inhibitor, antibiotic prophylaxis (eg, penicillin) against meningococcal and/or pneumococcal disease must be provided until 2 weeks after vaccination series has been completed.Δ§

Many experts also suggest prophylaxis against meningococcal disease for the duration of C1s or C3 complement inhibitor treatment, in addition to vaccination.[1,2]

This table serves as an overview of how to evaluate for and prevent infections in patients starting and/or taking C1s and C3 complement inhibitors. These complement inhibitors reduce the number of terminal complement components (C5b-9) that form the membrane attack complex, leading to impaired cytolysis of encapsulated bacteria.

Since neither vaccination nor antimicrobial prophylaxis can be expected to prevent all cases of infection in complement inhibitor recipients, patients should be educated about the risk of infection and encouraged to seek medical care immediately if any symptoms of meningococcal disease (eg, fever, headache, altered mentation, rash) or other infections occur.[1]

ACIP: United States Advisory Committee on Immunization Practices; FDA: Food and Drug Administration; Hib: Haemophilus influenzae type b.

* In addition to the infections listed, typical, common bacterial and viral infections should also be considered in the differential when infection is suspected in a patient taking the specified agent.

¶ Vaccination should be completed in accordance with current ACIP recommendations for patients receiving a complement inhibitor. For such patients, ACIP recommendations differ from the vaccine schedules included in United States prescribing information.[2-4] Tables of meningococcal and pneumococcal vaccine recommendations for persons at increased risk of disease are available separately in UpToDate. If vaccination cannot occur at least 2 weeks prior to therapy, it should be completed as soon as possible.

Δ The US FDA package insert for pegcetacoplan recommends pneumococcal vaccination in addition to meningococcal vaccination and to administer antibiotic prophylaxis if vaccine series is not completed prior to initiation of agent. Similar recommendations may apply to sutimlimab although these recommendations are not mentioned in the FDA package insert. Infectious diseases consultation is reasonable to determine the best course of action in these cases.

◊ Other vaccines indicated for immunocompromised individuals (eg, recombinant zoster vaccine) should also be administered once the individual is clinically stable.

§ For specific recommendations, refer to UpToDate content on prevention of meningococcal and pneumococcal disease.
References:
  1. McNamara LA, Topaz N, Wang X, et al. High risk for invasive meningococcal disease among patients receiving eculizumab (Soliris) despite receipt of meningococcal vaccine. MMWR Morb Mortal Wkly Rep 2017; 66:734.
  2. Mbaeyi SA, Bozio CH, Duffy J, et al. Meningococcal vaccination: Recommendations of the Advisory Committee on Immunization Practices, United States, 2020. MMWR Recomm Rep 2020; 69:1.
  3. Vaccine recommendations and guidelines of the ACIP: Altered immunocompetence. Centers for Disease Control and Prevention. https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/immunocompetence.html (Accessed on February 19, 2024).
  4. Kobayashi M, Pilishvili T, Farrar JL, et al. Pneumococcal vaccine for adults aged ≥19 years: Recommendations of the Advisory Committee on Immunization Practices, United States, 2023. MMWR Recomm Rep 2023; 72:1.

With additional data from:

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