BACKGROUND
Tumor necrosis factor-alpha inhibitors, including infliximab and adalimumab, are effective medical treatments for perianal fistulising Crohn’s disease (CD), but not all patients achieve fistula healing.
AIM
To determine the correlation between perianal fistula healing and closure with infliximab and adalimumab trough levels.
METHODS
In this multicentre retrospective study conducted across four tertiary inflammatory bowel disease centres in Australia, we identified CD patients with perianal fistulae on maintenance infliximab or adalimumab who had a trough level within twelve weeks of clinical assessment. Data collected included demographics, serum infliximab and adalimumab trough levels (mg/L) within 12 wk before or after their most recent clinical assessment and concomitant medical or surgical therapy. The primary outcome was fistula healing, defined as cessation in fistula drainage. The secondary outcome was fistula closure, defined as healing and closure of all external fistula openings. Differences between patients who did or did not achieve fistula healing were compared using the chi-square test,
t
test or Mann-Whitney
U
test.
RESULTS
One hundred and fourteen patients (66 infliximab, 48 adalimumab) were included. Forty-eight (72.7%) patients on maintenance infliximab achieved fistula healing and 18 (27.3%) achieved fistula closure. Thirty-seven (77%) patients on maintenance adalimumab achieved fistula healing and 17 (35.4%) achieved fistula closure. Patients who achieved fistula healing had significantly higher infliximab and adalimumab trough levels than patients who did not [infliximab: 6.4 (3.8-9.5)
vs
3.0 (0.3-6.2) mg/L,
P
= 0.003; adalimumab: 9.2 (6.5-12.0)
vs
5.4 (2.5-8.3) mg/L,
P
= 0.004]. For patients on infliximab, fistula healing was associated with lower rates of detectable anti-infliximab antibodies and younger age. For patients on adalimumab, fistula healing was associated with higher rates of combination therapy with an immunomodulator. Serum trough levels for patients with and without fistula closure were not significantly different for infliximab [6.9 (4.3-10.2)
vs
5.5 (2.5-8.3) mg/L,
P
= 0.105] or adalimumab [10.0 (6.6-12.0)
vs
7.8 (4.2-10.0) mg/L,
P
= 0.083].
CONCLUSION
Higher maintenance infliximab and adalimumab trough levels are associated with perianal fistula healing in CD.
Background: The aim of the present study was to evaluate safety and efficacy of Sri Sri TattvaTM immunity products, a combination of single herb and poly herb formulations in COVID-19 patients by assessing their clinical features and immune markers. The products when administered orally for a period of 14 days in COVID-19 patients demonstrated significant improvement in clinical symptoms.Methods: Patients with fever, cough, sore throat started responding to the treatment from day 3 and most of the patients were clinically free of symptoms by day 7. Early recovery from signs and symptoms was observed in most of the patients. Sri Sri TattvaTM immunity products has also demonstrated an excellent clinical improvement and immune markers including tumor necrosis factor (TNF-alfa), interleukin (IL-6), interferon (IFN-beta), D-dimer, ferritin, lactate dehydrogenease (LDH) and C-reactive protein (CRP) in COVID-19 patients.Results: The final results of this study showed that Sri Sri TattvaTM immunity products reduced the time to clinical cure and number of days in achieving negative real time polymerase chain reaction (RT-PCR) by early viral clearance when given along with standard of care thus reduced the duration of hospitalization.Conclusions: In the present study, 82% of COVID-19 patients cleared the virus within 10-14 days of study period reducing the duration of hospitalization. None of the patients progressed to severe COVID-19 and succumbed to the disease. This clearly indicates that Sri Sri TattvaTM immunity products when administered orally along with standard of care has definitive role in the management of COVID-19 patients.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.