Biologic therapies may expose patients to an increased risk for contracting infections, including this from live-attenuated vaccines.
Novel biologic therapies have become the preferred treatment for patients with moderate-to-severe psoriasis and atopic dermatitis (AD). However, due to the immunomodulatory and/or immunosuppressive effects, biologic therapies may expose patients to an increased risk for contracting certain infections—including those stemming from live-attenuated vaccines.
Jeffery M. Cohen, MD, and his colleague addressed this concern and provide guidance in their review in the Yale Journal of Biology and Medicine. As explained by Dr. Cohen, “Biologics have revolutionized the treatment of psoriasis and AD. While these therapies are generally safe, they are immunomodulatory. Therefore, certain vaccinations are recommended, and others are contraindicated for patients on these treatments.”
CDC Provides Guidelines for Patients on Specific Medications
The Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) provides best practices guidelines separately for patients who are on medications that can affect their immune system, such as biologics (Table).
Inactivated vaccines such as Haemophilius influenzae type b, hepatitis A and B, human papillomavirus (HPV), inactivated influenza, meningococcal, pneumococcal 13- and 23-valent (PCV13 and PPSV23), tetanus and diphtheria toxoids and acellular pertussis (TDAP), and recombinant zoster vaccines (RZV), do not carry any risk of causing infection in patients taking biologics and can, therefore, be administered in accordance with standard practice.
For Some, Live-Attenuated Vaccines Run the Risk for Severe Complications
Live-attenuated vaccines such as mumps, measles, rubella (MMR), oral poliomyelitis, oral typhoid fever, yellow fever, and varicella zoster vaccines run the risk for severe complications, including reactivation of the viruses, and are, therefore, contraindicated in patients who are on biologics. If these vaccines need to be administered, they must be given 14-30 days prior to initiation of biologics therapy or 3 months after the biologics therapy has concluded.
Recommendations for vaccinations against SARS-CoV-2 are constantly being updated as new information is being uncovered. Currently, all three approved COVID-19 vaccinations (ie, Pfizer-BioNTech, Moderna, and Johnson & Johnson’s Janssen) are considered safe and effective for patients on biologics. On November 17, 2021, the ACIP expanded the eligibility for the third dose of the Pfizer or Moderna vaccine for adults 6 months after receiving the second dose. Also, a second dose of the Johnson & Johnson’s vaccine is recommended to all adults for a booster dose 2 months after the initial dose. On February 17, 2022, boosters were recommended by the CDC for those on biologics; a third dose of the Pfizer and Moderna vaccines is recommended more than 28 days after the completion of the second dose followed by an additional booster dose administered 3 months after the third dose.
As for the Johnson & Johnson’s vaccine, patients should receive a second dose of either the Pfizer or Moderna vaccine more than 28 days after the initial dose and an additional booster at least 2 months following the second dose. Biologic medications should be continued during and after the administration of the vaccines.
Influenza Vaccinations Found Safe & Effective for Patients Taking TNF
Tumor necrosis factor-α (TNFα) inhibitors have had many clinical studies examine their safety and efficacy regarding vaccinations. Influenza vaccinations, for example, have been found to be safe and effective in patients who are taking TNFα inhibitors. This is applicable to combination therapies as well.
Studies have shown that patients prescribed an interleukin-12/23 (IL-12/23) inhibitor are able to safely and effectively be vaccinated with inactivated vaccines. However, live-attenuated vaccines are contraindicated. A phase III placebo-controlled study comparing 60 patients with psoriasis on an IL-12/23 inhibitor for 3 or more years with control subjects showed no difference in immune response between the two groups when they were administered pneumococcal and tetanus vaccinations. Other studies with different vaccines produced similar results.
IL-23 Inhibitors Need to Be Investigated for Safety
No clinical studies have evaluated IL-23 inhibitors. However, as with other biologics, live-attenuated vaccinations are contraindicated, and inactivated vaccinations are considered safe and may still be administered. Further studies are needed to understand the effect of this treatment on vaccinations.
Although some limited studies have examined IL-17 inhibitors and IL-4 receptor α/IL-4/IL-13 inhibitors, further studies are needed to determine the impact of these treatments on vaccinations. Currently, the recommendations specify that live attenuated vaccines are contraindicated with these biologics and inactivated vaccines can be used according to standard recommendations.