Flu Vaccine Response in Patients on Biologic Therapies

Patients receiving immunosuppressive therapies for rheumatologic diseases and inflammatory bowel disease (IBD) are at increased risk of serious infections, including influenza. Infections can also trigger flares of the underlying disease. Although newer biologic treatments are improving disease outcomes, these medications reduce vaccine responses, placing patients at high risk for vaccine-preventable illnesses. In a case-cohort study by Flannery et al. looking at influenza vaccine effectiveness from 2010-2014, only one in four children who died of laboratory-confirmed influenza were vaccinated, while a high prevalence (53%) had an underlying condition that put them at risk for severe influenza-related complications. Yearly influenza vaccination is recommended for all patients with rheumatologic diseases and IBD. However, these recommendations are based on studies that did not include patients receiving newer biologic therapies. Recent studies in organ transplant recipients, a group known to have suboptimal vaccine responses, have suggested a booster influenza vaccine strategy as a way of enhancing vaccine responses.

SPECIFIC AIMS:

The primary aim of this study is to assess the immunogenicity of booster dose influenza vaccine strategy in patients with rheumatologic diseases and IBD who are receiving immunosuppressive therapies.

Secondary aims of this study include assessment of the safety and clinical efficacy, of booster dose influenza vaccine in the prevention of influenza-like illnesses (ILI) in this patient population.

Inclusion criteria

• Children ages 3-22 years
• Rheumatologic condition (JIA, Uveitis, SLE and other rheumatologic disorders) or inflammatory bowel disease (Crohn's disease or ulcerative colitis) and who are receiving immunosuppressive therapies as follows:

• TNF inhibitors [etanercept (Enbrel), adalimumab (Humira®), infliximab (Remicade®)]
• anti IL -1 [anakinra (Kineret®) or canakinumab (Ilaris®)]
• IL-6 tocilizumab (Actemra®)
• anti IL-12/23 ustekinumab (Stelara®)
• anti CTLA-4 [abatacept (Orencia®)]
• vedolizumab (Entyvio®)
• azathioprine (Imuran®)
• 6 mercaptopurine (Purinethol®)
• Cyclosporine
• Leflunomide
• Mycophenolate
• methotrexate (Otrexup® or Rasuvo®)

Exclusion criteria

• Prior allergic reaction to any vaccine components
• Other contraindication to influenza vaccination
• Severe egg allergy
• Pregnancy
• Prior Guillain-Barre syndrome
• Therapy with oral corticosteroids ≥2 mg/mg/day within 4 weeks of study entry
• Prior rituximab
• Prior cyclophosphamide
• Prior IVIG within 8 weeks
• Acute febrile illness at time of study evaluation
• No prior history of two doses of influenza in the past for ages 3-8 years