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Endoscopic Findings
Patient Overview
42 patients who met the inclusion criteria were selected for this open clinical trial. 7 patients (16.7%) withdrew from the study within the first two months of treatment noticing no marked improvement, 6 patients due to intolerance to RMAT and 1 patient due to partial bowel obstruction and iatrogenic adrenal insufficiency.Responders
27 patients (77.1%) were categorized as responders since they demonstrated a significant improvement in their Crohn's disease while discontinuing all corticosteroids and immunosuppressants. 4 patients were maintained on low doses of mesalamine. Out of the 27 patients, 13 patients were still being treated with RMAT while 14 patients stopped RMAT. Out of the 14 patients who stopped RMAT, 11 (78.6%) stopped the antibiotics completely while 3 (21.4%) remained on Clarithromycin.
| Before | After |
Patient #1 6-17-99 |
Patient #1 5-03-00 |
Patient #2 2-1-99 |
Patient #2 4-3-00 |
Patient #3 7-21-98 |
Patient #3 3-5-99 |
Patient #4 6-12-98 |
Patient #4 8-11-98 |
Relapse
Of the 11 patients who discontinued treatment entirely, 5 (45.5%) patients relapsed with an average relapse time of 3.8 months (range 1 - 11 months). These 5 patients had an average treatment duration of 8 months (range 2 - 17 months). The patient relapsing in one month was treated with RMAT for 17 months.Partial-Responders
5 (14.3%) patients were categorized as non-responders. These patients were treated with RMAT but did not demonstrate a significant overall response to therapy. All 5 patients have stopped RMAT. 3 patients made a significant response at the start of treatment but then developed marked resistance to therapy as each patient relapsed. One of these patients demonstrated significant endoscopic healing, but relapsed while on treatment.Overall Initial Response
33/35 (94.3 %) patients made an overall initial response to RMAT.Endoscopic Healing
6 patients were endoscoped before and during RMAT. 4 patients identified as responders, demonstrated endoscopic healing. 1 partial responder had no evidence of healing. 1 non-responder showed significant healing initially (initial biopsy before RMAT cultured MAP positive) but developed resistance and relapsed (biopsy of relapsed tissue cultured MAP negative).Intolerance
Out of the initial 42 patients enrolled in this study, 12 (28.6%) patients were intolerant to RMAT and had to stop or alter their therapy. 6 patients withdrew from the study due to the adverse effects from the medications. The other 6 either completely stopped RMAT or altered their therapy due to their intolerance. These 6 patients categorized as responders since they were asymptomatic from their Crohn's disease without the need of corticosteroids and immunosuppressants. The main adverse effects noted throughout the course of treatment included: fatigue, moderate to severe arthralgia, mild skin reactions, decreased white blood cell counts and elevated liver enzymes. 13 patients (31.0%) experienced a Jarisch-Herxheimer-like reaction within the first month of RMAT. In the majority of these patients, flu-like symptoms subsided within two weeks.Measurement of Clinical Activity
Problems arose with patient compliance regarding the CDAI and IBDQ scores. There was not enough data to effectively determine overall patient response.
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