- Romão VC et al. Hepatitis B vaccination associated with low response in patients with rheumatic diseases treated with biologics. RMD Open 2023;9:e003597. doi:10.1136/rmdopen-2023-003597
The Portuguese researchers wanted to remedy this. They recruited a total of 100 test subjectsfor their prospective cohort study (DOI.org/10.1136/rmdopen-2023-003597):
All patients had not previously been vaccinated against HBV and had negative serology for anti-Hbs and anti-HBc. Around 80 per cent were treated with tumour necrosis factor inhibitors (TNFi), around two thirds additionally with csDMARDs. Most were in remission or showed low disease activity.
Both groups were vaccinated with Engerix-B 20 μg according to the basic immunisation schedule after 0.1 and 6 months. The immune response was checked at least one month after the last dose, and an anti-Hbs titre ≥10 IU/L was considered a success. In addition to the response to the vaccination as the primary endpoint, disease relapses, serious adverse events and immune-related disorders were recorded.
The alarming result: only 20 of the 62 patients (32 per cent) showed a positive response to the vaccination, compared to 36 of the 38 controls (95 per cent). In those who responded to the vaccination, the mean anti-HBs titre was also significantly lower than in the responding controls.
A closer look at the individual active substances showed that almost 40 per cent of patients treated with TNFi responded to the vaccination, although the range was wide. It ranged from 18 per cent for infliximab to 57 per cent for etanercept. In contrast, only around 10 per cent of those who received other bDMARDs responded. It was already known that rituximab impairs the vaccination response. Accordingly, none of the patients treated with it responded to the HBV vaccination. But even with the interleukin inhibitor tocilizumab, which has shown comparatively good response rates in studies to date, just 17 per cent developed a sufficient immune response.
In view of these sobering results, the authors argue in favour of vaccinating unprotected rheumatism patients before starting treatment with biologics, preferably immediately after diagnosis. Especially as the vaccination was well tolerated, and no relevant safety problems directly related to it occurred.
Further studies on this topic, which has so far been the subject of little research, must show whether a double dose of vaccine might even be useful, as recommended for renal insufficiency.