PMID- 37313946
OWN - NLM
STAT- MEDLINE
DCOM- 20230622
LR  - 20230722
IS  - 1998-4049 (Electronic)
IS  - 1319-3767 (Print)
IS  - 1319-3767 (Linking)
VI  - 29
IP  - 3
DP  - 2023 May-Jun
TI  - Exploring treatment of inflammatory bowel disease with infliximab in the Middle 
      East and Northern Africa: An analysis of the HARIR observational cohort study.
PG  - 164-170
LID - 10.4103/sjg.sjg_434_22 [doi]
AB  - BACKGROUND: In 2017, inflammatory bowel disease, including Crohn's disease (CD) 
      and ulcerative colitis (UC) affected more than 6.8 million people worldwide, with 
      increased incidence in newly industrialized countries. Although treatment options 
      were previously limited to symptom reduction, current approaches benefit from 
      disease-modifying biologics. In this study, we aimed to explore disease 
      characteristics, treatment, and outcomes of patients with CD or UC treated with 
      infliximab or golimumab in routine clinical practice in the Middle East and 
      Northern Africa. METHODS: HARIR was a prospective, observational, multicenter 
      study (NCT03006198), in patients who were treatment naive or who received two or 
      fewer biologic agents. Observed data from routine clinical practice were 
      presented descriptively. RESULTS: Data from 86 patients enrolled from five 
      countries (Algeria, Egypt, Kuwait, Qatar, and Saudi Arabia) were analyzed, 62 
      with CD and 24 with UC. All patients received infliximab. Clinically meaningful 
      efficacy data were observed only for the CD group (up to Month 3) due to limited 
      patient numbers. Crohn's Disease Activity Index (CDAI) scores at Month 3 
      indicated a positive response to treatment (reduced score of >/=70 and >/=25% 
      compared with baseline) for 14/48 (29.2%) patients; notably, 28/52 (53.8%) 
      patients had CDAI score <150 at baseline. Rates of serious and severe adverse 
      events (AEs) were low in both groups. The most common AEs were gastrointestinal 
      disorders. CONCLUSION: Infliximab treatment was well tolerated in this Middle 
      Eastern and Northern African population, and a clinical response was observed for 
      29.2% of CD patients. Limited accessibility to biologics and concomitant 
      treatments restricted study conduct.
FAU - Alharbi, Othman
AU  - Alharbi O
AD  - Gastroenterology Section, King Khalid University Hospital, College of Medicine, 
      King Saud University, Riyadh, Saudi Arabia.
FAU - Hamed, Waleed
AU  - Hamed W
AD  - Ain Shams University Hospital, Department of Tropical Medicine, Cairo, Egypt.
FAU - Salem, Osama
AU  - Salem O
AD  - Osama Ebada GI Center, Department of Internal Medicine, Alexandria, Egypt.
FAU - Taylor, Catherine
AU  - Taylor C
AD  - Janssen, Medical Affairs, Dubai, United Arab Emirates.
FAU - Besar, Ahmed
AU  - Besar A
AD  - Janssen, Medical Affairs, Dubai, United Arab Emirates.
FAU - Sharaf, Mohamed
AU  - Sharaf M
AD  - Janssen, Medical Affairs, Jeddah, Saudi Arabia.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
PL  - India
TA  - Saudi J Gastroenterol
JT  - Saudi journal of gastroenterology : official journal of the Saudi 
      Gastroenterology Association
JID - 9516979
RN  - 0 (Biological Products)
RN  - B72HH48FLU (Infliximab)
RN  - 91X1KLU43E (golimumab)
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Gastrointestinal Agents)
SB  - IM
MH  - Humans
MH  - Africa, Northern
MH  - *Biological Products
MH  - Cohort Studies
MH  - *Colitis, Ulcerative/drug therapy/epidemiology
MH  - Crohn Disease/drug therapy/epidemiology
MH  - *Inflammatory Bowel Diseases/drug therapy/epidemiology
MH  - *Infliximab/therapeutic use
MH  - Middle East/epidemiology
MH  - Prospective Studies
MH  - *Antibodies, Monoclonal/therapeutic use
MH  - Treatment Outcome
MH  - *Gastrointestinal Agents/therapeutic use
PMC - PMC10358795
OTO - NOTNLM
OT  - Crohn's disease
OT  - biologics
OT  - inflammatory bowel disease
OT  - infliximab
OT  - ulcerative colitis
COIS- None
EDAT- 2023/06/14 13:06
MHDA- 2023/06/15 06:42
PMCR- 2023/02/02
CRDT- 2023/06/14 06:14
PHST- 2023/06/15 06:42 [medline]
PHST- 2023/06/14 13:06 [pubmed]
PHST- 2023/06/14 06:14 [entrez]
PHST- 2023/02/02 00:00 [pmc-release]
AID - SaudiJGastroenterol_2023_29_3_164_369067 [pii]
AID - SJG-29-164 [pii]
AID - 10.4103/sjg.sjg_434_22 [doi]
PST - ppublish
SO  - Saudi J Gastroenterol. 2023 May-Jun;29(3):164-170. doi: 10.4103/sjg.sjg_434_22.