Hepatitis B vaccination associated with low response in patients with rheumatic diseases treated with biologics

• Published in: Rheumatic & musculoskeletal diseases open 2023-12, Vol.9 (4), p.e003597
• Main Authors: Romão, Vasco C, Ávila-Ribeiro, Pedro, Gonçalves, Maria João, Cruz-Machado, Rita, Guerreiro, André Bento, Teixeira, Vítor, Valido, Ana, Silva-Dinis, Joana, Vieira-Sousa, Elsa, Saavedra, Maria João, Sacadura-Leite, Ema, Marinho, Rui Tato, Fonseca, João Eurico
• Format: Article
• Language: English
• Subjects: Antirheumatic Agents - adverse effects; Arthritis; Biological Products - adverse effects; Biological Therapy; Hepatitis B; Hepatitis B - complications; Hepatitis B - drug therapy; Hepatitis B - prevention & control; Hepatitis B Antibodies; Humans; Immunization; Inflammatory bowel disease; Outcome Assessment, Health Care; Prospective Studies; Rheumatic Diseases - complications; Rheumatic Diseases - drug therapy; TNF inhibitors; Treatments; Tumor Necrosis Factor Inhibitors; Tumor necrosis factor-TNF; Vaccination
• ISSN: 2056-5933; 2056-5933
• DOI: 10.1136/rmdopen-2023-003597

BackgroundHepatitis B virus (HBV) vaccination is recommended for non-immunised patients with rheumatic diseases starting biological disease-modifying antirheumatic drugs (bDMARDs). There is some evidence that HBV vaccination is effective in patients under conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs), but it is currently unclear whether this also applies to bDMARDs.ObjectivesTo assess the efficacy and safety of HBV vaccination in patients with inflammatory arthritides treated with bDMARDs.MethodsA prospective cohort with inflammatory arthritides treated with bDMARDs, negative for anti-HBs and anti-HBc and never vaccinated for HBV was recruited. Engerix B was administered at 0, 1 and 6 months and anti-HBs was reassessed ≥1 month after last dose. Response was defined as anti-HBs≥10 IU/L and compared against vaccinated healthy controls. Disease flare, serious adverse events and immune-related disorders not previously present were recorded.Results62 patients, most treated with TNF inhibitors (TNFi), and 38 controls were recruited. Most patients were taking csDMARDs (67.7%) and were in remission/low disease activity (59.4%). Only 20/62 patients (32.3%) had a positive response to vaccination, in comparison to 36/38 age-matched controls (94.7%, p