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Impact of anaemia on infliximab concentrations and treatment outcomes in inflammatory bowel disease patients
Uticaj anemije na koncentracije infliksimaba i ishode lečenja kod pacijenata sa inflamatornim bolestima creva
aUniversity of Belgrade, Faculty of Pharmacy, Institute of Pharamcogenetics, Serbia bClinical Centre 'Zvezdara', Belgrade, Serbia
email: ana.homsek@pharmacy.bg.ac.rs
Project: optYmAb - Improving Clinical Outcomes with Precision Dosing in Patients with Inflammatory Bowel Disease Through Investigating Variability of Monoclonal Antibodies Based on Population Pharmacokinetic-Pharmacodynamic Modeling (ScienceFundRS_Prizma_BM - 6777)
Abstract
Up to 50% of patients with inflammatory bowel disease (IBD) experience extraintestinal manifestations, with anaemia being one of the most common (6-74% prevalence) [1]. Anaemia in IBD has previously been associated with poorer outcomes and reduced quality of life [2]. This research explored the relationship between anaemia and infliximab (IFX) concentrations, and its correlation with clinical and biochemical remission. Demographic characteristics, biochemical and clinical data were retrospectively collected for each patient at two time points: when IFX concentrations were measured during and in the absence of anaemia. Since the normality test indicated data were not normally distributed, non-parametric tests were implemented in IBM SPPS v29 (Wilcoxon - continuous variables; McNemar - categorical variables). Data were divided into two subsets by sex due to different HGB thresholds for diagnosing anaemia in men and women. The dataset included 52 patients (40.38% male, 46.15% Crohn's disease, median age 39 (18-65) years). Slightly, but significantly, lower median IFX concentrations were observed when anaemia was present in males (5.91 vs 11.48 mg/L) and females (3.26 vs 10.2 mg/L). Each marker of inflammation was significantly higher when patients were anaemic, with a significant increase in leukocyte count only in males (p=0.011). Also, male patients showed significantly (p<0.02) better treatment outcomes when anaemia was absent, whereas, in females, no significant difference in outcomes was observed. Slightly lower IFX concentrations suggest that clearance may be increased in anaemia. Findings related to treatment outcomes were inconclusive, indicating the need for further analysis in a larger patient population.
Sažetak
Do 50% pacijenata sa inflamatornom bolešću creva (IBC) ima ekstraintestinalne manifestacije, pri čemu je anemija jedna od najčešćih (prevalencija 6-74%) [1]. Anemija u IBC je prethodno povezana sa lošijim ishodima i smanjenim kvalitetom života [2]. Ovo istraživanje ispitivalo je povezanost anemije i koncentracije infliksimaba (IFX), kao i njenu korelaciju sa kliničkom i biohemijskom remisijom. Demografske karakteristike, biohemijski i klinički podaci su prikupljeni retrospektivno za svakog pacijenta u dve vremenske tačke: prilikom merenja koncentracije IFX tokom i u odsustvu anemičnog stanja. Pošto je test normalnosti pokazao da podaci nisu normalno distribuirani, neparametarski testovi su primenjeni u IBM SPPS v29 (Wilcoxon - kontinuirane varijable; McNemar - kategorijske varijable). Podaci su podeljeni u dva podskupa na osnovu pola zbog različitih nivoa hemoglobina za postavljanje dijagnoze anemije kod muškaraca i žena. Baza podataka sastojala se iz 52 pacijenta (40,38% muškaraca, 46,15% Kronova bolest, medijana starosti 39 (18-65) godina). Blago, ali značajno, niže medijane koncentracije IFX primećene su kada je anemija bila prisutna kod muškaraca (5,91 naspram 11,48 mg/L) i žena (3,26 naspram 10,2 mg/L). Svi markeri inflamacije su bili značajno viši kada su pacijenti bili anemični, sa značajnim povećanjem broja leukocita samo kod muškaraca (p=0,011). Takođe, muški pacijenti su pokazali značajno (p<0,02) bolje ishode lečenja kada anemija nije bila prisutna, dok kod žena nije primećena značajna razlika u ishodima. Nešto niže koncentracije IFX ukazuju da klirens može biti povećan usled anemije. Rezultati vezani za ishode lečenja su oprečni, te je neophodno da se dalja analiza sprovede na većoj populaciji pacijenata.
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