Abstract | BACKGROUND: METHODS: Clinical trial-like criteria were applied to an IBM MarketScan® claims database population-based cohort (n = 22,967) of patients with UC (October 2010 to September 2015) to identify a UC trial-like cohort treated with tumor necrosis factor inhibitors (TNFi; n = 6366) to compare with the tofacitinib UC clinical trial cohort (n = 1157). RESULTS: Incidence rates (events per 100 patient-years; [95% confidence interval]) in the UC trial-like cohort were as follows: serious infections, 3.33 (2.73-4.02); opportunistic infections (OIs; excluding herpes zoster [HZ]), 1.45 (1.06-1.93); HZ, 1.77 (1.34-2.29); malignancies (excluding nonmelanoma skin cancer [NMSC]), 0.63 (0.43-0.90); NMSC, 1.69 (1.35-2.10); major adverse cardiovascular events ( MACE), 0.51 (0.31-0.79); pulmonary embolism (PE), 0.54 (0.30-0.89); deep vein thrombosis (DVT), 1.41 (1.00-1.93); and gastrointestinal perforations, 0.31 (0.16-0.54). Compared with the UC trial-like cohort, tofacitinib-treated patients had numerically lower incidence rates for serious infections (1.75 [1.27-2.36]), OIs (excluding HZ; 0.16 [0.04-0.42]), NMSC (0.78 [0.47-1.22]), PE (0.16 [0.04-0.41]), and DVT (0.04 [0.00-0.23]), and a higher rate for HZ (3.57 [2.84-4.43]); rates for malignancies (excluding NMSC), MACE, and gastrointestinal perforations were similar. CONCLUSIONS: When acknowledging limitations of comparing claims data with controlled clinical trial data, incidence rates for HZ among TNFi-treated patients in the UC trial-like cohort were lower than in the tofacitinib UC clinical trial cohort; rates for serious infections, OIs, NMSC, PE, and DVT were numerically higher. CLINICALTRIALS.GOV: NCT00787202, NCT01465763, NCT01458951, NCT01458574, NCT01470612.
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Authors | Jeffrey R Curtis, Miguel Regueiro, Huifeng Yun, Chinyu Su, Marco DiBonaventura, Nervin Lawendy, Chudy I Nduaka, Nana Koram, Joseph C Cappelleri, Gary Chan, Irene Modesto, Gary R Lichtenstein |
Journal | Inflammatory bowel diseases
(Inflamm Bowel Dis)
Vol. 27
Issue 9
Pg. 1394-1408
(08 19 2021)
ISSN: 1536-4844 [Electronic] England |
PMID | 33324993
(Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
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Copyright | © 2020 Crohn’s & Colitis Foundation. Published by Oxford University Press on behalf of Crohn’s & Colitis Foundation. |
Chemical References |
- Piperidines
- Pyrimidines
- tofacitinib
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Topics |
- Colitis, Ulcerative
(drug therapy, epidemiology)
- Humans
- Neoplasms
- Opportunistic Infections
- Piperidines
(therapeutic use)
- Product Surveillance, Postmarketing
- Pyrimidines
(therapeutic use)
- Randomized Controlled Trials as Topic
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