scholarly journals P292 Effect of drug therapy on the lipid profiles of patient with Inflammatory Bowel Disease: a systematic review and meta-analysis

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S322-S323
Author(s):  
J A M Sleutjes ◽  
J E Roeters van Lennep ◽  
E Boersma ◽  
A C de Vries ◽  
C J van der Woude

Abstract Background Increases of lipid levels associated with inflammatory bowel disease (IBD) medication have been previously reported. However, it is unknown whether this effect is similar for all IBD drug classes. Methods We performed a systematic literature search of randomized controlled trials and observational cohort studies of IBD treatment with corticosteroids, anti TNFα agents and tofacitinib that assessed total cholesterol (TC) before and after short-term (≤8 week) and long-term (≥12 week) treatment. Data of 11 studies (1,663 IBD patients) were pooled using a random effect model with as primary outcome TC levels. Lipid changes were reported as mean difference on the log2-scale (MDlog2) with 95% CI. The effect of patient and disease characteristics on TC changes were analyzed in 6 studies with individual patient data of 1,211 patients. Results A significant increase in TC was observed after treatment with corticosteroids, anti TNFα agents and tofacitinib (short-term +0.370, +0.197 and +0.190; long-term: +0.452, +0.068 and +0.162, respectively). (Figure 1) After correcting for age, sex, BMI and CRP, increases of TC levels after start of corticosteroids and tofacitinib treatment were higher (short-term: +0.293 and +0.161; long-term: +0.090 and +0.127, respectively) as compared to anti TNFα agents (short-term: -0.059, long-term: +0.041). (Figure 2) Conclusion Changes in lipid levels differ between IBD drug classes. TC levels increase was strongest for corticosteroids followed by tofacitinib but not observed for anti TNFα agents. Whether TC change associated with IBD treatment has effect on CVD risk requires further study.

2019 ◽  
Vol 35 (3) ◽  
pp. 412-417 ◽  
Author(s):  
Yuichi Matsuno ◽  
Atsushi Hirano ◽  
Takehiro Torisu ◽  
Yasuharu Okamoto ◽  
Yuta Fuyuno ◽  
...  

2020 ◽  
Vol 51 (9) ◽  
pp. 870-879 ◽  
Author(s):  
Iago Rodríguez-Lago ◽  
Jesús Castro-Poceiro ◽  
Agnès Fernández-Clotet ◽  
Francisco Mesonero ◽  
Antonio López-Sanromán ◽  
...  

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S482-S483
Author(s):  
L Guberna Blanco ◽  
O P Nyssen ◽  
M Chaparro ◽  
J P Gisbert

Abstract Background Loss of response to anti-TNF therapies in inflammatory bowel disease occurs in a high proportion of patients. However, the precise incidence of dose intensification (DI) and its effectiveness remain unclear. Our aims were: (1) To evaluate the need of DI of anti-TNF therapy either by increasing the dose or decreasing doses’ interval; (2) To evaluate possible variables influencing its requirement; (3) To assess the effectiveness of empirical DI. Methods Bibliographical searches were performed until January 2019. Selection: prospective and retrospective studies assessing the loss of response to anti-TNF therapy, considered as the need of DI, in Crohn’s disease (CD) and ulcerative colitis (UC) patients treated for at least 12 weeks with an anti-TNF drug. Exclusion criteria: Studies using anti-TNF as prophylaxis for postoperative recurrence in CD or those where DI was based on therapeutic drug monitoring. Data were analyzed by means of the inverse variance method using a random effect model and stratifying by medical baseline condition (UC vs. CD), anti-TNF drug and follow-up. Effectiveness was assessed by intention-to-treat analysis. Results Up to now, 107 studies (11,377 patients) were included. The overall rate of DI requirement for naïve patients after 12 and 36 months of follow-up was 35% (95% CI=26–45%, I2=95%, 15 studies) and 48% (41–55%, I2= 77%, 9 studies); respectively. Frequencies of DI requirement stratified by subgroup analysis are presented in the table (all patients being naïve except CD patients treated with adalimumab (ADA), including naïve and no naïve). The overall short-term response and remission rates to empirical DI were 67% (95% CI: 63–72%; I2=73%; 31 studies) and 45% (95% CI: 35–55%; I2=9%; 23 studies), respectively; subgroup analyses are summarised in the table. Conclusion Loss of response to anti-TNF agents and consequent DI occurs frequently in both UC and CD, with an overall rate of DI requirement of 35% at one year and 48% at 3 years. Empirical DI is a relatively effective therapeutic option. Further data extraction and analysis is necessary to confirm these findings.


2021 ◽  
Vol 9 (02) ◽  
pp. 644-654
Author(s):  
Zeba Samreen ◽  
◽  
Minhaj Sultana ◽  
Mohd Shanawazuddin ◽  
Tahoora Zainab ◽  
...  

Background:-The aim of the study is to compare and evaluate the efficacy and safety of short-term outcomes of tacrolimus in inflammatory bowel disease (IBD) patients who were not concomitantly receiving other immunosuppressive therapies by carrying out an observational prospective study of tacrolimus (TAC) v/s corticosteroid (CS) therapy in the treatment of IBD in active phase, to prevent patient from long term use of CS by reducing the incidence rate of flare. To use TAC as a step-up approach in IBD by early induction of remission and maintain it for longer period which reduces re-hospitalization and surgery rate hence improving quality of life. Method And Material:-The study was conducted in gastroenterology department, Princess Esra hospital, Hyd. 50 patients were enrolled based on our inclusion and exclusion criteria, allocated in 2 groups receiving CS and TAC respectively for 10 days. Follow-ups were done and at the end of 2 months, again a colonoscopy was performed to assess the effectiveness of the treatment. Results:-At an initial therapy of 2 months, clinical remissions were observed in most of the patients of both the groups. After six months of treatment, TAC showed 100% remission rate while 20% patients on CS have shown flare. Conclusion:- prolongs period of remission, and prevents the long-term use of CS thereby preventing its complications proving step-up to be a better approach towards the management of IBD. This study concludes that the efficacy and safety profile of TAC was overall favorable, and the doses were well tolerated by most of the patients.


2019 ◽  
Vol 25 (1) ◽  
pp. 57-63 ◽  
Author(s):  
Clara Yzet ◽  
Stacy S. Tse ◽  
Maia Kayal ◽  
Robert Hirten ◽  
Jean-Frédéric Colombel

The emergence of biologic therapies has revolutionized the management of inflammatory bowel disease (IBD) by halting disease progression, increasing remission rates and improving long-term clinical outcomes. Despite these well-described benefits, many patients are reluctant to commence therapy due to drug safety concerns. Adverse events can be detected at each stage of drug development and during the post-marketing period. In this article, we review how to best assess the safety parameters of new IBD medications, from the earliest stage of development to population-based registries, with a focus on the special populations often excluded from the evaluation process.


Author(s):  
Stefanie Howaldt ◽  
Eugeni Domènech ◽  
Nicholas Martinez ◽  
Carsten Schmidt ◽  
Bernd Bokemeyer

Abstract Background Iron-deficiency anemia is common in inflammatory bowel disease, requiring oral or intravenous iron replacement therapy. Treatment with standard oral irons is limited by poor absorption and gastrointestinal toxicity. Ferric maltol is an oral iron designed for improved absorption and tolerability. Methods In this open-label, phase 3b trial (EudraCT 2015-002496-26 and NCT02680756), adults with nonseverely active inflammatory bowel disease and iron-deficiency anemia (hemoglobin, 8.0-11.0/12.0 g/dL [women/men]; ferritin, <30 ng/mL/<100 ng/mL with transferrin saturation <20%) were randomized to oral ferric maltol 30 mg twice daily or intravenous ferric carboxymaltose given according to each center’s standard practice. The primary endpoint was a hemoglobin responder rate (≥2 g/dL increase or normalization) at week 12, with a 20% noninferiority limit in the intent-to-treat and per-protocol populations. Results For the intent-to-treat (ferric maltol, n = 125/ferric carboxymaltose, n = 125) and per-protocol (n = 78/88) analyses, week 12 responder rates were 67% and 68%, respectively, for ferric maltol vs 84% and 85%, respectively, for ferric carboxymaltose. As the confidence intervals crossed the noninferiority margin, the primary endpoint was not met. Mean hemoglobin increases at weeks 12, 24, and 52 were 2.5 vs 3.0 g/dL, 2.9 vs 2.8 g/dL, and 2.7 vs 2.8 g/dL with ferric maltol vs ferric carboxymaltose. Treatment-emergent adverse events occurred in 59% and 36% of patients, respectively, and resulted in treatment discontinuation in 10% and 3% of patients, respectively. Conclusions Ferric maltol achieved clinically relevant increases in hemoglobin but did not show noninferiority vs ferric carboxymaltose at week 12. Both treatments had comparable long-term effectiveness for hemoglobin and ferritin over 52 weeks and were well tolerated.


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