Impact of biologics and small molecules for inflammatory bowel disease on COVID ‐19‐related hospitalization and mortality: A systematic review and meta‐analysis
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Abstract
Background and Aim
The use of biologics and small molecules has been a concern for patients with inflammatory bowel disease (IBD) during the COVID‐19 pandemic. We aimed to assess the association between the risk of COVID‐19‐related hospitalization and these agents.
Methods
We made a systematic review and meta‐analysis of all published studies from December 2019 to September 2021 to identify studies that reported COVID‐19‐related hospitalization in IBD patients receiving biologic therapies or tofacitinib. We calculated the risk ratio (RR) to compare the relative risk of COVID‐19‐related hospitalization in patients receiving these medications to those who were not, at the time of the study.
Results
Eighteen studies were included. The relative risk of hospitalization was significantly lower in patients with IBD and COVID‐19 who were receiving biologic therapy (RR = 0.47 [95% confidence interval, CI: 0.42–0.52, P < 0.00001]) compared to patients not receiving biologics. The RR was lower in patients receiving anti‐tumor necrosis factors (TNFs) compared to those who were not (RR = 0.48 [95% CI: 0.41–0.55, P < 0.00001]). A similar finding was observed in patients taking ustekinumab (RR = 0.55 [95% CI: 0.43–0.72, P < 0.00001]). Combination therapy involving anti‐TNF and an immunomodulator did not lower the risk of COVID‐19‐related hospitalization (RR = 0.98 [95% CI: 0.82–1.18, P = 0.84]). The use of vedolizumab (RR = 1.13 [95% CI: 0.75–1.73, P = 0.56]) or tofacitinib (RR = 0.81 [95% CI: 0.49–1.33, P = 0.40]) was not associated with a lower risk of COVID‐19‐related hospitalization.
Conclusion
Regarding COVID‐19‐related hospitalization in IBD, anti‐TNFs and ustekinumab were associated with decreased risk of hospitalization. In addition, vedolizumab and tofacitinib were not associated with COVID‐19‐related hospitalization.
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SciScore for 10.1101/2021.10.24.21265344: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics not detected. Sex as a biological variable not detected. Randomization In terms of types of studies, we included randomized, controlled trials, observational studies, and editorial were included. Blinding not detected. Power Analysis not detected. Table 2: Resources
Software and Algorithms Sentences Resources Search Strategy: MEDLINE, Embase, Scopus, and Cochrane Central Register of Controlled Trials databases were searched from December 1st, 2019, to September 1st, 2021, using predetermined search terms (Supplementary file table 1). MEDLINEsuggested: (MEDLINE, RRID:SCR_002185)Embasesuggested: (EMBASE, RRID:SCR_001650)Cochrane Central Register of Controlled Trialssuggested: (Cochrane Central Register of …SciScore for 10.1101/2021.10.24.21265344: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics not detected. Sex as a biological variable not detected. Randomization In terms of types of studies, we included randomized, controlled trials, observational studies, and editorial were included. Blinding not detected. Power Analysis not detected. Table 2: Resources
Software and Algorithms Sentences Resources Search Strategy: MEDLINE, Embase, Scopus, and Cochrane Central Register of Controlled Trials databases were searched from December 1st, 2019, to September 1st, 2021, using predetermined search terms (Supplementary file table 1). MEDLINEsuggested: (MEDLINE, RRID:SCR_002185)Embasesuggested: (EMBASE, RRID:SCR_001650)Cochrane Central Register of Controlled Trialssuggested: (Cochrane Central Register of Controlled Trials, RRID:SCR_006576)Furthermore, Google scholar was also searched for unindexed studies. Google scholarsuggested: (Google Scholar, RRID:SCR_008878)Statistical analysis was conducted using Review Manager (RevMan) version 5.3.5 (The Cochrane Collaboration). RevMansuggested: (RevMan, RRID:SCR_003581)Cochrane Collaborationsuggested: NoneResults from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:Inclusion of good quality studies with detailed extraction of data, and rigorous evaluation of study quality lend great credibility and strength to our systematic review and meta-analysis Our study limitations include the observational nature of included studies with risk of confounding and selection bias. Furthermore, patient level data were lacking, and insufficient data is available to stratify patients by different factors, including age, disease activity, and socio-economic assessments of the patients. Additional research is needed to ascertain which risk factors play significant roles in causing COVID-19 related hospitalization. Finally, the majority of patients included in our study were extracted from the SECURE-IBD database. One disadvantage of this database is that it may be subject to reporting bias, which means that physicians tend to document severe cases, while the milder cases may remain underreported. Additional research is needed to further evaluate causality between the use of biologic therapies and COVID-19 outcomes. In conclusion, Regarding COVID-19 related hospitalization in IBD, Anti-TNFs and ustekinumab were associated with favorable outcomes. In addition, vedolizumab and tofacitinib were not associated with COVID-19 related hospitalization.
Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04425538 Completed A Phase 2 Trial of Infliximab in Coronavirus Disease 2019 (C… Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
Results from scite Reference Check: We found no unreliable references.
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