Efficacy of Nirmatrelvir/Ritonavir (Paxlovid) for COVID-19 in Vaccinated Patients With Inflammatory Bowel Disease
Background:
Subsets of patients with inflammatory bowel disease (IBD) especially those on certain immunosuppressive drugs are at increased risk for developing complications if they develop COVID-19 infection. We have previously demonstrated that in unvaccinated patients with IBD, use of Nirmatrelvir with Ritonavir (Paxlovid) was associated with a decreased risk of hospitalization (adjusted odds ratio [aOR], 0.35; 95% CI, 0.17–0.74) compared with the IBD control cohort. No patients died, required ICU care, or intubation/respiratory support in the Paxlovid arm while as many as 1.8% of patients in the IBD control arm died (Clin Gastroenterol Hepatol. 2023 Mar;21(3):841-843). Paxlovid efficacy has yet to be evaluated in vaccinated patients with IBD and therefore the aim of our study was to assess the efficacy of Paxlovid in reducing hospitalization and improving COVID-19 outcomes in vaccinated patients with IBD.
Methods:
We conducted a retrospective cohort study using TriNetX, a multi-institutional database in patients with IBD who developed COVID-19 after 2 or more doses of COVID-19 vaccine and received Paxlovid compared to patients who did not receive Paxlovid (control cohort). The primary aim was risk of hospitalization after 48 hours and within 30 days from diagnosis of COVID-19. One to one propensity score matching was performed for demographics, co-morbid conditions and IBD medications. The secondary aim was a composite outcome of ICU admission, intubation and any-cause mortality. Subgroup analysis was performed for age >65, IBD sub-type, IBD patients on immunomodulators and/or advanced therapies, vaccination timing and recent (< 6 months) steroid use. Risk was expressed adjusted odds ratio with 95% confidence interval (CI).
Results:
Among the 2773 vaccinated patients with IBD and COVID-19 infection, 1,166 (%) received Paxlovid (mean age 61 ± 16.2 years old, female sex 51.9%, White 77.5%, Crohn’s disease 40.3%). There was no difference in the risk hospitalization between the Paxlovid cohort and control cohort (2.3% vs 3.36%; aOR 0.67, 95% CI 0.40-1.14, P= 0.14). Regarding the secondary composite outcome of ICU admission, intubation or mortality, the rates were very low in both groups and there was no clinical or statistical difference (aOR 1, 95% CI 0.4-2.41, <italic>P =</italic> 0.97). After sub-group analysis, there was no difference in the risk of hospitalization based on age ≥ 65, ulcerative colitis, Crohn’s disease, immunosuppressive therapy, last vaccine dose >6 months and recent steroid use.
Conclusions:
Nirmatrelvir/ Ritonavir (Paxlovid) use was not associated with a decreased risk of hospitalization in vaccinated patients with IBD diagnosed with COVID-19 infection. Continued administration of COVID-19 vaccines to patients with IBD remains an effective method to reduce morbidity and mortality and should be recommended to all patients with IBD. The impact of Paxlovid on time to symptom resolution needs to be further explored in future prospective studies.
