Back to Authors

Caldera, Freddy

0000-0003-1960-6611

Mayo Clinic

University of Wisconsin School of Medicine and Public Health, Department of Medicine, Division of Gastroenterology and Hepatology, Madison, WI, United States.

Citations 37

Utility of a Third Heplisav-B Dose in Patients With Inflammatory Bowel Disease Without Immunity After 2-Dose Heplisav-B Vaccination
Karime, Christian , Black, Cecily N., Cortés, Pedro , Kwon, Joshua , Caldera, Freddy , Crosby, Sheena , Picco, Michael F., Kinnucan, Jami , Farraye, Francis A. , Kwon, Joshua Y , Crosby, Sheena K , Kinnucan, Jami A., Farraye, Francis A , Caldera, Freddy , Cortés, Pedro , Hashash, Jana G.

American Journal of Gastroenterology | May 8, 2024 | Volume: 119 | Issue: 10 | Pages: 2079-2085

10.14309/ajg.0000000000002863 Get It

INTRODUCTION: Hepatitis B virus (HBV) vaccination is recommended in patients with inflammatory bowel disease (IBD). Although the 2-dose Heplisav-B vaccine has proven effective, more than 20% of patients with IBD do not seroconvert. We prospectively evaluated the effectiveness of a third Heplisav-B dose in patients with IBD lacking HBV immunity despite 2-dose vaccination. METHODS: Adults with IBD who had received 2-dose Heplisav-B vaccination between 2018 and 2023 were identified. Seroconversion was defined as hepatitis B surface antibody (HBsAb) ≥ 10 IU/L measured at ≥4 weeks after vaccination. Patients who did not seroconvert were prospectively offered a third Heplisav-B dose, followed by repeat HBsAb measurement. Demographic, clinical, medication, and vaccination data were compared between those who did and did not seroconvert. RESULTS: Of 192 patients identified, 71.9% (138/192) seroconverted after 2-dose Heplisav-B vaccination. The 54 patients (28.1%) who did not seroconvert were more likely to be male, have diabetes, chronic kidney disease, or elevated Charlson Comorbidity Index. Of the 54 patients, 30 (55.6%) elected to receive a third Heplisav-B dose, with 56.7% (17/30) achieving seroconversion (median HBsAb titer 376 IU/L, IQR 47–1,000 IU/L) despite a median intervaccination time of 416 days (IQR 90.8–667.8). No differences were noted between patients who did vs did not seroconvert after third-dose vaccination. DISCUSSION: In patients with IBD lacking HBV immunity despite 2-dose Heplisav-B vaccination, administration of a third dose resulted in a 56.7% seroconversion rate. Our results suggest that administration of an additional Heplisav-B dose may be an effective strategy in patients lacking immunity despite primary 2-dose vaccination.
Higher and Sustained Cell-Mediated Immune Responses After 3 Doses of mRNA COVID-19 Vaccine in Patients With Inflammatory Bowel Disease on Anti–Tumor Necrosis Factor Therapy
Caldera, Freddy , Rolak, Stacey , Necela, Brian M. , Cogen, Davitte , Zona, Emily E., Schell, Trevor , Ramirez, Oscar Ramirez , Almasry, Mazen, Chun, Kelly , Knutson, Keith L. , Caldera, Freddy , Schell, Trevor L , Ramirez Ramirez, Oscar , Farraye, Francis A. , Hayney, Mary S. , Knutson, Keith L.

Clinical and Translational Gastroenterology | February 13, 2024 | Volume: 15 | Issue: 4 | Pages: e00688

10.14309/ctg.0000000000000688 Get It

INTRODUCTION: Studies suggest that the generation of durable T-cell immunity following coronavirus disease 2019 (COVID-19) vaccination protects against severe disease. The aim of this study was to measure cell-mediated immune response (CMIR) 1–2 months and 6 months after a third dose of a COVID-19 mRNA vaccine. METHODS: This prospective study (HumoRal and CellULar initial and Sustained immunogenicity in patients with inflammatory bowel disease [IBD]) evaluated CMIR at 28–65 days (t 1 ) after dose 2, 28–65 days (t 2 ) (n = 183) and 6 months (±45 days) (t 3 ) (n = 167) after a third dose of an mRNA COVID-19 vaccine. A small cohort had blood sample available 28–65 days (t 4 ) (n = 55) after a fourth dose. Primary outcomes were CMIR at (t 2 ) and (t 3 ). Secondary outcomes included the effect of immunosuppressing IBD medications on CMIR and response at (t 4 ). RESULTS: All patients had measurable CMIR at all time points. CMIR increased at t 2 compared with that at t 1 (median 1,467 responding cells per million (interquartile range [IQR] 410–5,971) vs 313 (94–960) P < 0.001). There was no significant waning in t 2 vs t 3 or significant boosting at t 4 . Those on anti–tumor necrosis factor monotherapy had a higher CMIR compared with those not on this therapy at t 2 (4,132 [IQR 1,136–8,795] vs 869 [IQR 343–3,221] P < 0.001) and t 3 (2,843 [IQR 596–6,459] vs 654 [IQR 143–2,067] P < 0.001). In univariable analysis, anti–tumor necrosis factor monotherapy was associated with a higher CMIR at t 2 ( P < 0.001) and t 3 ( P < 0.001) and confirmed in a multivariable model ( P < 0.001). DISCUSSION: A third dose of a COVID-19 vaccine boosts CMIR, and the response is sustained in patients with IBD.
Patients With Inflammatory Bowel Disease Are at Increased Risk of Hospitalization Due to Respiratory Syncytial Virus
Smith, Ryan A. , Desai, Aakash , Barnes, Edward L. , Hayney, Mary S. , Kochhar, Gursimran , Farraye, Francis A. , Caldera, Freddy , Hayney, Mary , Farraye, Francis A , Caldera, Freddy , Barnes, Edward L , Desai, Aakash , Hashash, Jana G.

American Journal of Gastroenterology | February 6, 2024 | Volume: 119 | Issue: 8 | Pages: 1545-1554

10.14309/ajg.0000000000002682 Get It

INTRODUCTION: Patients with inflammatory bowel disease (IBD) are at increased risk of developing respiratory infections. Respiratory syncytial virus (RSV) is a common respiratory virus with adverse outcomes in older adults. This study aimed to determine whether patients with IBD are at increased risk of a serious infection due to RSV. METHODS: We conducted a retrospective study using the multi-institutional research network TriNetX to assess the risk of hospitalization in a cohort of patients with IBD compared with that in a non-IBD control cohort with RSV infection from January 1, 2007, to February 27, 2023. One-to-one (1:1) propensity score matching was performed for demographic variables and RSV risk factors between the 2 cohorts. Risk was expressed as adjusted odds ratio (aOR) with 95% confidence interval (CI). RESULTS: There were 794 patients in the IBD-RSV cohort and 93,074 patients in the non–IBD-RSV cohort. The mean age of the IBD-RSV cohort was 55.6 ± 20 years, 59% were female, 80% were White, and 56.9% had Crohn's disease. The IBD-RSV cohort was at an increased risk of hospitalization (aOR 1.30, 95% CI 1.06–1.59). There was no difference in the risk (aOR 0.83, 95% CI 0.58–1.19) of a composite outcome of hospitalization-related complications between the 2 cohorts. Recent systemic corticosteroid use (<3 months) was associated with an increased risk of hospitalization (aOR 1.86, 95% CI 1.30–2.59) in the IBD-RSV cohort. DISCUSSION: We found that adult patients with IBD and RSV infection are at an increased risk of hospitalization and may benefit from the new RSV vaccine recommended for adults aged 60 years and older.
Recombinant Zoster Vaccine [RZV] is Effective in Patients with Inflammatory Bowel Disease: A US Propensity Matched Cohort Study
Desai, Aakash , Kochhar, Gursimran , Caldera, Freddy , Caldera, Freddy , Desai, Aakash , Hashash, Jana G. , Hayney, Mary S. , Farraye, Francis A.

Journal of Crohn's and Colitis | January 15, 2024 | Volume: 18 | Issue: 6 | Pages: 828-835

10.1093/ecco-jcc/jjae008 Get It

Abstract Background Recombinant zoster vaccine [RZV] reduces the short-term risk of herpes zoster [HZ] in patients with inflammatory bowel disease [IBD]. However, there is lack of data regarding the long-term effectiveness in this population. Methods A retrospective cohort study was conducted in adults ≥50 years old using TriNetX database between patients with IBD who received two doses of RZV [IBD-RZV cohort] and patients who did not receive RZV [IBD control cohort]. The primary outcome was risk of incident HZ. One-to-one propensity score matching was performed for demographic parameters, comorbid conditions, and IBD medications. Risk was expressed as adjusted odds ratio [aOR] with 95% confidence intervals [CI]. Results The IBD-RZV cohort [n = 5489; mean age 63.2 ± 9.1 years; 57.2% females] was identified with a mean follow-up of 900.9 days. IBD-RZV cohort had a lower risk of HZ [aOR 0.44, 95% CI 0.32-0.62] compared with IBD control cohort. The risk of HZ was lower in patients aged 50–65 years [aOR 0.41, 95% CI 0.25-0.68] and patients &gt;65 years [aOR 0.64, 95% CI 0.42-0.96]. There was a lower risk of HZ in patients with ulcerative colitis [aOR 0.41, 95% CI 0.27-0.63] and Crohn’s disease [aOR 0.44, 95% CI 0.26-0.74] in the IBD-RZV cohort compared with IBD control cohort. Conclusion RZV is associated with a lower long-term risk of HZ in patients ≥50 years old with IBD. Given the widespread availability and safety of RZV, more effective vaccination strategies are needed to improve RZV use in this high-risk population.
Racial, Ethnic, and Geographic Disparities in Immunization Rates Among Patients With Inflammatory Bowel Disease
Beniwal‐Patel, Poonam , Waclawik, Gabrielle, Browning, Keely, Urmat, Aijan, Schell, Trevor , Smith, Ryan C. , Huerta, Antonio, Hipp, Lauren E. , Davé, Sonya , Shah, Neemit , Dillon, Kayla E, Reiter-Schreurs, Katelyn, Russ, Rachel K., Mailig, Miguel, Osman, Fauzia , Weiss, Jennifer , Caldera, Freddy , Caldera, Freddy , Schell, Trevor L , Huerta, Antonio, Dillon, Kayla , Farraye, Francis A. , Hayney, Mary S.

Crohn's & Colitis 360 | December 15, 2023 | Volume: 5 | Issue: 4 | Pages: No page available

10.1093/crocol/otad078 Get It

Abstract Background and Aims Racial and ethnic disparities exist in the treatment of IBD. These disparities exist in adult vaccine uptake among the general population and may extend to patients with IBD. The primary aim of this study was to determine whether racial, ethnic, or geographic disparities existed in influenza vaccine uptake among patients with IBD. Methods We performed a multicenter, retrospective cohort study evaluating adult vaccine uptake among patients with IBD seen at two tertiary referral centers between September 2019 and February 2020. The primary outcome was to determine if racial/ethnic and geographic disparities existed in influenza vaccine uptake for the two prior seasons. Our secondary outcomes were to determine if disparities existed for pneumococcal, zoster, or hepatitis B vaccines. Results Among the 2453 patients who met the inclusion criteria, most identified as non-Hispanic White (89.9%), were on immunosuppressive therapy (74.5%), and received the influenza vaccine in both seasons (56.0%). Older age (prevalence ratio (PR) 0.98; 95% confidence interval (95%CI) 0.98-0.99; P &lt; .001) and non-Hispanic White patients (PR 0.76, 95%CI 0.59–0.98, P &lt; 0.03) were significantly more likely to be immunized. Black patients (PR 1.37; 95%CI 1.18–1.59; P &lt; .001) and those living in underserved geographic areas (PR 1.35; 95%CI 1.17–1.56; P &lt; 0.001) were less likely to be immunized. Racial/ethnic and geographic disparities were identified for pneumococcal, zoster, and hepatitis B vaccine uptake. Conclusions Racial and ethnic vaccination uptake disparities exist among patients with IBD; patients from medically underserved areas are also vulnerable to these disparities Studies identifying patient, provider, and system-level opportunities to address these disparities are needed.
Addressing the Risks of Respiratory Syncytial Virus for Patients With Inflammatory Bowel Disease in the Era of Novel Vaccines
Smith, Ryan A. , Desai, Aakash , Farraye, Francis A. , Caldera, Freddy , Caldera, Freddy , Farraye, Francis A , Desai, Aakash , Hashash, Jana G. , Hayney, Mary S.

Inflammatory Bowel Diseases | September 20, 2023 | Volume: 29 | Issue: 11 | Pages: 1842-1845

10.1093/ibd/izad233 Get It

Increased Risk of Herpes Zoster in Adult Patients with Inflammatory Bowel Disease After SARS-CoV2 Infection: A Propensity-Matched Cohort Study
Desai, Aakash , Soni, Aakriti, Hashash, Jana G. , Kochhar, Gursimran , Caldera, Freddy , Hashash, Jana G , Caldera, Freddy , Desai, Aakash , Hayney, Mary S. , Farraye, Francis A.

Inflammatory Bowel Diseases | August 4, 2023 | Volume: 30 | Issue: 7 | Pages: 1094-1102

10.1093/ibd/izad162 Get It

Abstract Background There is evidence that SARS-CoV2 infection can increase the risk of herpes zoster (HZ) in the general population. However, the risk in patients with inflammatory bowel disease (IBD) is not known. Methods The TriNetX database was utilized to conduct a retrospective cohort study in patients with IBD after SARS-CoV2 infection and patients without a SARS-CoV2 infection (IBD control cohort). The primary outcome was to evaluate the risk of HZ between the 2 cohorts. One-to-one (1:1) propensity score matching was performed for demographic parameters, HZ risk factors and IBD medications between the 2 cohorts. Adjusted odds ratio (aOR) with 95% confidence interval (CI) were calculated. Results After propensity score matching, patients with IBD with a SARS-CoV2 infection were at an increased risk for HZ (aOR, 2.16; 95% CI, 1.53-3.04) compared with IBD control cohort in the pre-COVID-19 vaccine era. There was no difference in the risk (aOR, 0.87; 95% CI, 0.44-1.75) of a composite outcome of HZ complications (hospitalization, post-herpetic neuralgia, and neurologic complications) between the 2 cohorts. The IBD SARS-CoV2 cohort was also at an increased risk for HZ (aOR, 3.04; 95% CI, 1.48-6.24) compared with IBD control cohort in the postvaccine era. However, the risk of HZ in the postvaccine era was decreased (aOR, 0.45; 95% CI, 0.27-0.76) compared with IBD SARS-CoV2 cohort in the prevaccine era. Conclusions Our study showed that SARS-CoV2 infection is associated with an increased risk of HZ in patients with IBD.
Editorial: adjuvanted recombinant zoster vaccine in adults with inflammatory bowel disease—time for universal recommendation? Authors' reply
Caldera, Freddy , Spaulding, Aaron , Spaulding, Aaron C. , Spaulding, Aaron , Caldera, Freddy , Hayney, Mary S. , Farraye, Francis A.

Alimentary Pharmacology & Therapeutics | May 11, 2023 | Volume: 57 | Issue: 11 | Pages: 1345-1346

10.1111/apt.17519 Get It

LINKED CONTENTThis article is linked to Caldera et al papers. To view these articles, visit https://doi.org/10.1111/apt.17454 and https://doi.org/10.1111/apt.17490
Additional COVID-19 Booster Doses Increase Anti-spike Serum Antibody Concentrations Among Patients With Inflammatory Bowel Disease
Schell, Trevor , Almasry, Mazen, Caldera, Freddy , Ramirez, Oscar Ramirez , Caldera, Freddy , Schell, Trevor L , Ramirez Ramirez, Oscar , Ramirez, Oscar, Farraye, Francis A. , Hayney, Mary S.

Inflammatory Bowel Diseases | April 18, 2023 | Volume: 29 | Issue: 10 | Pages: e38-e39

10.1093/ibd/izad068 Get It

Cost‐effectiveness of an adjuvanted recombinant zoster vaccine in adults with inflammatory bowel disease
Caldera, Freddy , Spaulding, Aaron , Moriarty, Jim, Zhu, Ye , Spaulding, Aaron C. , Spaulding, Aaron , Caldera, Freddy , Borah, Bijan J. , Hayney, Mary S. , Farraye, Francis A.

Alimentary Pharmacology & Therapeutics | March 10, 2023 | Volume: 57 | Issue: 11 | Pages: 1326-1334

10.1111/apt.17454 Get It

Summary Background Recombinant zoster vaccine (RZV) is recommended for all adults ≥19 years of age who are at increased risk for HZ, including patients with inflammatory bowel disease (IBD). Methods A Markov model was constructed to compare the RZV cost‐effectiveness with no vaccination in patients with Crohn's Disease (CD) and ulcerative colitis (UC). A simulated cohort of 1 million patients was used for each IBD group at ages 18, 30, 40, and 50. The primary objective of this analysis was to compare RZV cost‐effectiveness in patients with CD and UC, comparing vaccination to no vaccination. Results Overall, vaccination is cost‐effective for both CD and UC, with the incremental cost‐effectiveness ratio (ICERs) below $100,000/quality‐adjusted life years (QALY) for all age cohorts. For patients with CD, 30 years of age and older, and those with UC 40 years and older, vaccination was both more effective and less expensive than the non‐vaccinated strategy (CD ≥30: ICERs $6183–$24,878 and UC ≥40: ICERs $9163–$19,655). However, for CD patients under 30 (CD 18: ICER $2098) and UC patients under 40 (UC = 18: ICER $11,609, and UC = 30: $1343), costs were greater for vaccinated patients, but there was an increase in QALY. One‐way sensitivity analysis of age indicates that cost break‐even occurs at age 21.8 for the CD group and 31.5 for the UC group. In probabilistic sensitivity analysis, 92% of both CD and UC simulations indicated that vaccination was preferred. Conclusion In our model, vaccination with RZV was cost‐effective for all adult patients with IBD.