Assessment of Trough Levels and Efficacy of Infliximab and Adalimumab in Inflammatory Bowel Disease Patients.

1. Approval will be obtained from Research Ethics Committee of Faculty of Pharmacy, Damanhour University 2. All participants agree to take part in this clinical study, will agree to provide an informed written consent 3. Patients will be divided into 2 treatment groups [group 1 (n=20): patients will receive IFX], [group 2 (n=20): patients will receive ADA]. 4. Statistical tests appropriate to the study will be conducted to evaluate significance of results 5. Results, conclusion, discussion and recommendations will be given

• Type of Study: prospective study for IBD patients receiving either adalimumab or infliximab.
• Study Setting: The Inflammatory Bowel disease outpatient clinic, Tropical Medicine department, Ain Shams University Hospitals.
• Sample Size: Study will be conducted on 40 patients with Inflammatory Bowel Disease (IBD).
• Study procedure

1. Laboratory investigations

a) At baseline, all patients will be subjected to i. full history taking regarding: Loss of appetite, abdominal pain, number of motions, bleeding per rectum, number of attacks per year, need for hospitalization per year, Loss of weight, extra intestinal manifestations, anemic manifestations, drug history, ii. Testing the viral markers (HCV Ab, HBs Ag, HB core IgG, HIV) and Tuberculine test or Quantifferon test. (To Exclude latent TB) b) At Baseline and in follow ups, patient will be assessed for the following laboratory investigations: i. Complete blood count (CBC). ii. Liver profile (albumin, INR, total & direct bilirubin, AST, ALT) iii. Kidney function tests e.g BUN and creatinine. iv. Inflammatory Markers (C-reactive protein (CRP), estimated sedimentation Ratio (ESR)).

v. Stool analysis (WBC's, RBC's, Parasite) vi. Stool culture and sensitivity. vii. Urine analysis. c) Trough concentration of ADA and IFX will be assessed after reaching steady state levels.