One-year risk of serious infection in patients treated with certolizumab pegol as compared with other TNF inhibitors in a real-world setting: data from a national U.S. rheumatoid arthritis registry
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Registry comparison of infection risk across TNF inhibitors that applies propensity matching to reduce channeling bias; bias adjustment is used as a tool and the knowledge produced is about drug safety.
The registry study estimates medication safety in rheumatoid arthritis patients rather than studying research practice.
Real-world drug safety comparison in RA; uses propensity methods to answer a clinical question, not to study methods.
Résumé
BACKGROUND: Registry studies provide a valuable source of comparative safety data for tumor necrosis factor inhibitors (TNFi) used in rheumatoid arthritis (RA), but they are subject to channeling bias. Comparing safety outcomes without accounting for channeling bias can lead to inaccurate comparisons between TNFi prescribed at different stages of the disease. In the present study, we examined the incidence of serious infection and other adverse events during certolizumab pegol (CZP) use vs other TNFi in a U.S. RA cohort before and after using a methodological approach to minimize channeling bias. METHODS: Patients with RA enrolled in the Corrona registry, aged ≥ 18 years, initiating CZP or other TNFi (etanercept, adalimumab, golimumab, or infliximab) after May 1, 2009 (n = 6215 initiations), were followed for ≤ 12 months. A propensity score (PS) model was used to control for baseline characteristics associated with the probability of receiving CZP vs other TNFi. Incidence rate ratios (IRRs) of serious infectious events (SIEs), malignancies, and cardiovascular events (CVEs) in the CZP group vs other TNFi group were calculated with 95% CIs, before and after PS matching. RESULTS: Patients were more likely to initiate CZP later in the course of therapy than those initiating other TNFi. CZP initiators (n = 975) were older and had longer disease duration, more active disease, and greater disability than other TNFi initiators (n = 5240). After PS matching, there were no clinically important differences between CZP (n = 952) and other TNFi (n = 952). Before PS matching, CZP was associated with a greater incidence of SIEs (IRR 1.53 [95% CI 1.13, 2.05]). The risk of SIEs was not different between groups after PS matching (IRR 1.26 [95% CI 0.84, 1.90]). The 95% CI of the IRRs for malignancies or CVEs included unity, regardless of PS matching, suggesting no difference in risk between CZP and other TNFi. CONCLUSIONS: After using PS matching to minimize channeling bias and compare patients with a similar likelihood of receiving CZP or other TNFi, the 1-year risk of SIEs, malignancies, and CVEs was not distinguishable between the two groups.
Conservé avec la notice de tri, où il sert de preuve aux étiquettes ci-dessus.
La notice
- Revue
- Arthritis Research & Therapy
- Thématique
- Rheumatoid Arthritis Research and Therapies
- Domaine
- Medicine
- Établissements canadiens
- —
- Organismes subventionnaires
- UCB PharmaGenentechHorizon PharmaMomenta PharmaceuticalsValeant Pharmaceuticals InternationalGilead SciencesAmgenPfizerEli Lilly and CompanyBristol-Myers Squibb
- Mots-clés
- Certolizumab pegolMedicineGolimumabEtanerceptAdalimumabRheumatoid arthritisInfliximabInternal medicineAbataceptIncidence (geometry)Propensity score matchingCohortRheumatologyTNF inhibitorAdverse effectDiseaseRituximabLymphoma
- Résumé présent dans OpenAlex
- oui