Effectiveness of Biologic Therapy in Inflammatory Bowel Disease in Duhok
(A new reading in the comparison between the creations of Meyerhold and Brecht)
Keywords:
Inflammatory bowel disease, Crohn’s disease, ulcerative colitis, biologic therapy.Abstract
Background: Ulcerative colitis (UC) and Crohn's disease (CD) are chronic inflammatory bowel disorders (IBD). Biological therapy uses monoclonal antibodies against chronic inflammatory disease targets. Aim: To determine the primary response rate, the primary non-response rate (PNR) & the secondary loss of response rate (SLR) to biologic agents in patients with IBD. Also, to determine the side effect profile of biologic agents in patients with IBD. Patients and methods: This cross-sectional case series study was done in Azadi gastroenterology and hepatology center in Duhok, Iraq from March, 2022 to September, 2022. It included 40 IBD patients with diseased activity ranging from moderate to severe disease. The male: female ratio was 1.7 and the mean age was 27.2 years ranging between 9-60 years. Results: Of the study population, 7 (17.5%) had UC and 33 (82.5%) had Crohn’s disease. The primary response rate was 62.5% (N=25) while the primary non response rate was 30% (N=12). The secondary loss of response rate was 7.5% (N=3) during the study period of 6 months. Mean CDAI was significantly reduced after second follow up of biological treatment (P=0.01) at 3 months of follow up. Patients on Remicade had the highest percentage of response and asymptomatic remission 83.3% compared to Remsima 59.3% and Adalimumab 0%. Biological therapy side effects were positive in 5% (N=2) is the form of skin rash. Conclusions: Biologic therapy have an acceptable effectiveness and safety profile for patients with moderate to severe disease activity. However, more studies are warranted to establish the cause of PNR and SLR to increase the effectiveness of these medications in future.
Downloads
References
Kaplan GG, Windsor JW. The four epidemiological stages in the global
evolution of inflammatory bowel disease. Nature reviews
Gastroenterology & hepatology. 2021 Jan;18(l):56-66.
Balestrieri P, Ribolsi M, Guarino MP, et al. Nutritional aspects in
inflammatory bowel diseases. Nutrients. 2020 Jan 31;12(2):372.
Guan Q. A Comprehensive Review and Update on the Pathogenesis of
Inflammatory Bowel Disease. J Immunol Res. 2019:7247238. doi:
1155/2019/7247238. PMID: 31886308; PMCID: PMC6914932.
Chang JT. Pathophysiology of inflammatory bowel diseases. New
England Journal of Medicine. 2020;383(27):2652-2664.
Seyedian SS, Nokhostin F, Malamir MD. A review of the diagnosis,
prevention, and treatment methods of inflammatory bowel disease.
Journal of medicine and life. 2019;12(2):113.
Flynn S, Eisenstein S. Inflammatory bowel disease presentation and
diagnosis. Surgical Clinics. 2019;99(6):1051-1062.
Singha S, Georgec J, Bolanda BS, et al. Primary Non-Response to Tumor
Necrosis Factor Antagonists is Associated with Inferior Response to
Second-line Biologies in Patients with Inflammatory Bowel Diseases:
A Systematic Review and Meta-analysis. Journal of Crohn's and
Colitis, 2018, 635-643Levine A, Rhodes JM, Lindsay JO, et al. Dietary guidance from the
international organization for the study of inflammatory bowel
diseases. Clinical Gastroenterology and Hepatology.
;18(6):1381-1392.
Actis GC, Pellicano R, Fagoonee S, et al. History of inflammatory bowel
diseases. Journal of clinical medicine. 2019;8(l l):1970.
Osnes J, Gower-Rousseau C, Seksik P Cortot A, et al. Epidemiology and
natural history of inflammatory bowel diseases. Gastroenterology
;140:1785-1794.
Molodecky NA, Soon IS, Rabi DM, et al. Increasing incidence and
prevalence of the inflammatory bowel diseases with time, based on
systematic review. Gastroenterology 2012;142:46-54.
Charpentier C, Salleron J, Savoye G, et al. Natural history of elderly-onset
inflammatory bowel disease: a population-based cohort study. Gut
;63:423-432.
Crocco S, Martelossi S, Giurici N, et al. Upper gastrointestinal
involvement in paediatric onset Crohn’s disease: prevalence and
clinical implications. J Crohns Colitis 2012;6:51-55.
Burisch J, Pedersen N, Cukovic-Cavka S, et al. East-west gradient in the
incidence of inflammatory bowel disease in Europe: the ECCOEpiCom inception cohort. Gut 2014;63:588-597.
Vind L, Riis T, Jess E, et al. Increasing incidences of inflammatory bowel
disease and decreasing surgery rates in Copenhagen City and
County, 2003-2005: a population-based study from the Danish
Crohn colitis database. Am J Gastroenterol 2006;101:1274-1282.
Lakatos L, Kiss LS, David G, et al. Incidence, disease phenotype at
diagnosis, and early disease course in inflammatory bowel diseases
in Western Hungary, 2002-2006. Inflamm Bowel Dis 2011;17:2558—
Munkholm P, Langholz E, Nielsen OH, et al. Incidence and prevalence
of Crohn’s disease in the county of Copenhagen, 1962-87: a sixfold
increase in incidence. Scand J Gastroenterol 1992;27:609-614.
Shivananda S, Lennard-Jones J, Logan R, et al. Incidence of
inflammatory bowel disease across Europe: is there a difference
between north and south? Results of the European Collaborative
Study on Inflammatory Bowel Disease (EC-IBD). Gut 1996;39:690—
Bjornsson S, Johannsson JH. Inflammatory bowel disease in Iceland,
-1994: a prospective, nationwide, epidemiologi-cal study. Eur J
Gastroenterol Hepatol 2000;12:31-38.
Loftus CG, Loftus EV, Harmsen WS, et al. Update on the incidence and
prevalence of Crohn’s disease and ulcerative colitis in Olmsted
County, Minnesota, 1940-2000. Inflamm Bowel Dis 2007;13:254-
Herrinton LJ, Liu L, Lafata JE, et al. Estimation of the period prevalence
of inflammatory bowel disease among nine health plans using
computerized diagnoses and outpatient pharmacy dispensings.
Inflamm Bowel Dis. 2007;13:451-461.
Herrinton LJ, Liu L, Lewis JD, et al. Incidence and prevalence of
inflammatory bowel disease in a northern California managed care
organization, 1996-2002. Am J Gastroenterol. 2008;103:1998-2006.
Kappelman MD, Rifas-Shiman SL, Kleinman K, et al. The prevalence and
geographic distribution of Crohn’s disease and ulcerative colitis in
the United States. Clin Gastroenterol Hepatol. 2007;5:1424-1429.
Kugathasan S, Judd RH, Hoffmann RG, et al. Epidemiologic and clinical
characteristics of children with newly diagnosed inflammatory bowel
disease in Wisconsin: a statewide population-based study. J Pediatr.
;143:525-531.
Loftus CG, Loftus EV Jr, Harmsen WS, et al. Update on the incidence and
prevalence of Crohn’s disease and ulcerative colitis in Olmsted
county, Minnesota, 1940-2000. Inflamm Bowel Dis. 2007;13:254-
Hamasur KS. Prevalence of oral manifestations of inflammatory bowel
disease in patients admitted to Sulaymaniyah teaching hospital-Iraq.
AL-Kindy College Medical Journal. 2020 Sep 5;16(1):47-53.
Bastida G, Beltran B. Ulcerative colitis in smokers, non-smokers
and ex-smokers. World J Gastroenterol. 2011;17(22):2740-2747.
Papamichael K, Gils A, Rutgeerts P, et al. Role for therapeutic drug
monitoring during induction therapy with TNF antagonists in IBD:
evolution in the definition and management of primary
nonresponse. Inflamm Bowel Dis 2015;21:182-97.
Gisbert JP, Marin AC, McNicholl AG, et al. Systematic review with meta¬
analysis: the efficacy of a second anti-TNF in patients with
inflammatory bowel disease whose previous anti-TNF treatment has
failed. Aliment Pharmacol Ther 2015;41:613-23.
Reinisch W, Sandborn WJ, Hommes DW, et al. Adalimumab for induction of
clinical remission in moderately to severely active ulcerative colitis:results of a
randomised controlled trial. Gut 2011;60(6):780-787.
Harper JW, Sinanan MN, Zisman TL. Increased body mass index is
associated with earlier time to loss of response to infliximab in
patients with inflammatory bowel disease. Inflamm Bowel Dis.
;19(10):2118-2124.
Colombel JF, Sandborn WJ, Rutgeerts P, et al. Adalimumab for maintenance of
clinical response and remission in patients with Crohn’s disease: theCHARM
trial. Gastroenterology. 2007;132(l):52-65.
Sandborn WJ, van Assche G, Reinisch W, et al. Adalimumab induces and
maintains clinical remission in patients with moderate-to-severe
ulcerative colitis. Gastroenterology. 2012;142(2):257-265.
Vermeire S, Louis E, Carbonez A, et al. Belgian Group of Infliximab
Expanded Access Program in Crohn’s Disease. Demographic and
clinical parameters influencing the short-term outcome of anti¬
tumor necrosis factor (infliximab) treatment in Crohn’s disease. Am
J Gastroenterol. 2002;97(9):2357-2363.
Flamant M, Roblin X. Inflammatory bowel disease: towards a
personalized medicine [published online January 10, 2018]. Therap
Adv Gastroenterol, doi:10.1177/1756283X17745029.
Billioud V, Sandborn WJ, Peyrin-Biroulet L. Loss of response and need
for adalimumab dose intensification in Crohn’s disease: a systematic
review. Am J Gastroenterol. 2011;106(4):674-684.
Gisbert JP, Panes J. Loss of response and requirement of infliximab dose
intensification in Crohn’s disease: a review. Am J Gastroenterol.
;104(3):760-767.
Afif W, Loftus EV Jr, Faubion WA, et al. Clinical utility of measuring
infliximab and human anti-chimeric antibody concentrations in
patients with inflammatory bowel disease. Am J Gastroenterol.
;105(5):1133-1139.
Singh S, Fumery M, Sandborn WJ, Murad MH. Systematic review and
network meta-analysis: first- and second-line biologic therapies for
moderate-severe Crohn’s disease. Aliment Pharmacol Ther.
;48(4):394-409.
Reinisch W, Sandborn WJ, Hommes DW, et al. Adalimumab for
induction of clinical remission in moderately to severely active
ulcerative colitis: results of a randomised controlled trial. Gut.
;60(6):780-787.
Hibi T, Sakuraba A, Watanabe M, et al. C-reactive protein is an indicator
of serum infliximab level in predicting loss of response in patients
with Crohn’s disease. J Gastroenterol. 2014;49(2):254-262.
Magro F, Rodrigues-Pinto E, Santos-Antunes J, et al. High C-reactive
protein in Crohn’s disease patients predicts nonresponse to
infliximab treatment. J Crohns Colitis. 2014;8(2):129-136.
Ungar B, Chowers Y, Yavzori M, et al; ABIRISK consortium. The
temporal evolution of antidrug antibodies in patients with
inflammatory bowel disease treated with infliximab. Gut.
;63(8):1258-1264.
Downloads
Published
Issue
Section
License
You are free to:
- Share — copy and redistribute the material in any medium or format for any purpose, even commercially.
- Adapt — remix, transform, and build upon the material for any purpose, even commercially.
- The licensor cannot revoke these freedoms as long as you follow the license terms.
Under the following terms:
- Attribution — You must give appropriate credit , provide a link to the license, and indicate if changes were made . You may do so in any reasonable manner, but not in any way that suggests the licensor endorses you or your use.
- No additional restrictions — You may not apply legal terms or technological measures that legally restrict others from doing anything the license permits.
Notices:
You do not have to comply with the license for elements of the material in the public domain or where your use is permitted by an applicable exception or limitation .
No warranties are given. The license may not give you all of the permissions necessary for your intended use. For example, other rights such as publicity, privacy, or moral rights may limit how you use the material.
