Antibody responses to Influenza vaccination are diminished in patients with inflammatory bowel disease on infliximab or tofacitinib

Background and Aims: We sought to determine whether six commonly used immunosuppressive regimens were associated with lower antibody responses after seasonal influenza vaccination in patients with inflammatory bowel disease [IBD]. Methods: We conducted a prospective study including 213 IBD patients and 53 healthy controls: 165 who had received seasonal influenza vaccine and 101 who had not. IBD medications included infliximab, thiopurines, infliximab and thiopurine combination therapy, ustekinumab, vedolizumab, or tofacitinib. The primary outcome was antibody responses against influenza/A H3N2 and A/H1N1, compared to controls, adjusting for age, prior vaccination, and interval between vaccination and sampling. Results: Lower antibody responses against influenza A/H3N2 were observed in patients on infliximab (geometric mean ratio 0.35 [95% confidence interval 0.20–0.60], p = 0.0002), combination of infliximab and thiopurine therapy (0.46 [0.27–0.79], p = 0.0050), and tofacitinib (0.28 [0.14–0.57], p = 0.0005) compared to controls. Lower antibody responses against A/H1N1 were observed in patients on infliximab (0.29 [0.15–0.56], p = 0.0003), combination of infliximab and thiopurine therapy (0.34 [0.17–0.66], p = 0.0016), thiopurine monotherapy (0.46 [0.24–0.87], p = 0.017), and tofacitinib (0.23 [0.10–0.56], p = 0.0013). Ustekinumab and vedolizumab were not associated with reduced antibody responses against A/H3N2 or A/H1N1. Vaccination in the previous year was associated with higher antibody responses to A/H3N2. Vaccine-induced anti-SARS-CoV-2 antibody concentration weakly correlated with antibodies against H3N2 [r = 0.27; p = 0.0004] and H1N1 [r = 0.33; p < 0.0001]. Conclusions: Vaccination in both the 2020–2021 and 2021–2022 seasons was associated with significantly higher antibody responses to influenza/A than no vaccination or vaccination in 2021–2022 alone. Infliximab and tofacitinib are associated with lower binding antibody responses to influenza/A, similar to COVID-19 vaccine-induced antibody responses

COVID-19 vaccine-induced antibody responses in immunosuppressed patients with inflammatory bowel disease (VIP): a multicentre, prospective, case-control study.

BACKGROUND: The effects that therapies for inflammatory bowel disease (IBD) have on immune responses to SARS-CoV-2 vaccination are not yet fully known. Therefore, we sought to determine whether COVID-19 vaccine-induced antibody responses were altered in patients with IBD on commonly used immunosuppressive drugs. METHODS: In this multicentre, prospective, case-control study (VIP), we recruited adults with IBD treated with one of six different immunosuppressive treatment regimens (thiopurines, infliximab, a thiopurine plus infliximab, ustekinumab, vedolizumab, or tofacitinib) and healthy control participants from nine centres in the UK. Eligible participants were aged 18 years or older and had received two doses of COVID-19 vaccines (either ChAdOx1 nCoV-19 [Oxford-AstraZeneca], BNT162b2 [Pfizer-BioNTech], or mRNA1273 [Moderna]) 6-12 weeks apart (according to scheduling adopted in the UK). We measured antibody responses 53-92 days after a second vaccine dose using the Roche Elecsys Anti-SARS-CoV-2 spike electrochemiluminescence immunoassay. The primary outcome was anti-SARS-CoV-2 spike protein antibody concentrations in participants without previous SARS-CoV-2 infection, adjusted by age and vaccine type, and was analysed by use of multivariable linear regression models. This study is registered in the ISRCTN Registry, ISRCTN13495664, and is ongoing. FINDINGS: Between May 31 and Nov 24, 2021, we recruited 483 participants, including patients with IBD being treated with thiopurines (n=78), infliximab (n=63), a thiopurine plus infliximab (n=72), ustekinumab (n=57), vedolizumab (n=62), or tofacitinib (n=30), and 121 healthy controls. We included 370 participants without evidence of previous infection in our primary analysis. Geometric mean anti-SARS-CoV-2 spike protein antibody concentrations were significantly lower in patients treated with infliximab (156·8 U/mL [geometric SD 5·7]; p<0·0001), infliximab plus thiopurine (111·1 U/mL [5·7]; p<0·0001), or tofacitinib (429·5 U/mL [3·1]; p=0·0012) compared with controls (1578·3 U/mL [3·7]). There were no significant differences in antibody concentrations between patients treated with thiopurine monotherapy (1019·8 U/mL [4·3]; p=0·74), ustekinumab (582·4 U/mL [4·6]; p=0·11), or vedolizumab (954·0 U/mL [4·1]; p=0·50) and healthy controls. In multivariable modelling, lower anti-SARS-CoV-2 spike protein antibody concentrations were independently associated with infliximab (geometric mean ratio 0·12, 95% CI 0·08-0·17; p<0·0001) and tofacitinib (0·43, 0·23-0·81; p=0·0095), but not with ustekinumab (0·69, 0·41-1·19; p=0·18), thiopurines (0·89, 0·64-1·24; p=0·50), or vedolizumab (1·16, 0·74-1·83; p=0·51). mRNA vaccines (3·68, 2·80-4·84; p<0·0001; vs adenovirus vector vaccines) were independently associated with higher antibody concentrations and older age per decade (0·79, 0·72-0·87; p<0·0001) with lower antibody concentrations. INTERPRETATION: For patients with IBD, the immunogenicity of COVID-19 vaccines varies according to immunosuppressive drug exposure, and is attenuated in recipients of infliximab, infliximab plus thiopurines, and tofacitinib. Scheduling of third primary, or booster, doses could be personalised on the basis of an individual's treatment, and patients taking anti-tumour necrosis factor and tofacitinib should be prioritised. FUNDING: Pfizer

Speech understandability of repaired cleft palate patients pre and post caregiver training

Background: Treating speech and language problems in repaired cleft palate patients in India is still an uphill task due to lack of facilities. This study attempted to use parents as team members for the speech management of cleft palate patients in Andhra Pradesh, India. Objectives: To investigate whether a positive change in speech understandability for individuals with cleft palate will result from a parent-administered intervention program. Materials and Methods: Twenty-eight parents had enrolled for the speech camp held in September 2004. The parent-training program at the speech camp ensured that parents were given adequate awareness. Out of the 28, 18 (64.28%) reported for one follow-up, referred to in this article as Group I. Ten (35.72%) out of the 28 came for two consecutive follow-ups, referred to in this article as Group II. Results: Pre and post training understandability scores obtained in the known context (reciting a familiar poem in the native language, counting 1 to 10) and unknown context (peer group names, family information, describing their journey from home to hospital) for Group I and Group II were evaluated. Results revealed that a higher percentage of cases showed significant improvement in understandability in the unknown context after treatment. Unknown context can be considered a measure to assess speech understandability after training. Further, it shows that parent training without practice at home may not show the desired results. Conclusion: This study reveals that parents can effect a positive change in the speech understandability of their children following training, provided the exercises are carried out regularly at home and the parents report for the follow-up assessments and guidance

Speech understandability of repaired cleft palate patients pre and post caregiver training

Background: Treating speech and language problems in repaired cleft palate patients in India is still an uphill task due to lack of facilities. This study attempted to use parents as team members for the speech management of cleft palate patients in Andhra Pradesh, India. Objectives: To investigate whether a positive change in speech understandability for individuals with cleft palate will result from a parent-administered intervention program. Materials and Methods: Twenty-eight parents had enrolled for the speech camp held in September 2004. The parent-training program at the speech camp ensured that parents were given adequate awareness. Out of the 28, 18 (64.28%) reported for one follow-up, referred to in this article as Group I. Ten (35.72%) out of the 28 came for two consecutive follow-ups, referred to in this article as Group II. Results: Pre and post training understandability scores obtained in the known context (reciting a familiar poem in the native language, counting 1 to 10) and unknown context (peer group names, family information, describing their journey from home to hospital) for Group I and Group II were evaluated. Results revealed that a higher percentage of cases showed significant improvement in understandability in the unknown context after treatment. Unknown context can be considered a measure to assess speech understandability after training. Further, it shows that parent training without practice at home may not show the desired results. Conclusion: This study reveals that parents can effect a positive change in the speech understandability of their children following training, provided the exercises are carried out regularly at home and the parents report for the follow-up assessments and guidance

Speech understandability of repaired cleft palate patients pre and post caregiver training

Background: Treating speech and language problems in repaired cleft palate patients in India is still an uphill task due to lack of facilities. This study attempted to use parents as team members for the speech management of cleft palate patients in Andhra Pradesh, India. Objectives: To investigate whether a positive change in speech understandability for individuals with cleft palate will result from a parent-administered intervention program. Materials and Methods: Twenty-eight parents had enrolled for the speech camp held in September 2004. The parent-training program at the speech camp ensured that parents were given adequate awareness. Out of the 28, 18 (64.28&#x0025;) reported for one follow-up, referred to in this article as Group I. Ten (35.72&#x0025;) out of the 28 came for two consecutive follow-ups, referred to in this article as Group II. Results: Pre and post training understandability scores obtained in the known context (reciting a familiar poem in the native language, counting 1 to 10) and unknown context (peer group names, family information, describing their journey from home to hospital) for Group I and Group II were evaluated. Results revealed that a higher percentage of cases showed significant improvement in understandability in the unknown context after treatment. Unknown context can be considered a measure to assess speech understandability after training. Further, it shows that parent training without practice at home may not show the desired results. Conclusion: This study reveals that parents can effect a positive change in the speech understandability of their children following training, provided the exercises are carried out regularly at home and the parents report for the follow-up assessments and guidance