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Noriko Kamata, Kenji Watanabe, P-98 YI The Precise Treatment Strategy for Adalimumab According to Endoscopic Evaluation in Patients With Crohn's Disease, Inflammatory Bowel Diseases, Volume 18, Issue suppl_1, 1 December 2012, Page S54, https://doi.org/10.1097/00054725-201212001-00131
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The aim of the present study is to evaluate the clinical and endoscopic efficacy of adalimumab(ADA) in patients with Crohn's disease (CD) who had been treated with or without Infliximab(IFX) prospectively. And we investigated the clinical strategy for ADA based on the endoscopic efficacy.
Suitable endoscopic examination (ileocolonoscopy or balloon enteroscopy) was performed to assess the most inflamed lesion before and after 28 weeks for ADA treatment. We evaluated the clinical and endoscopic efficacy according to Harvey-Bradshaw Index (HBI: remission <4) or CRP, endoscopic efficacy according to simple endoscopic score for Crohn's disease (SES-CD). The endoscopic efficacy was defined by the decreasing SES-CD score. The primary endpoint is endoscopic efficacy at 28 weeks.
80 CD patients (mean age: 35.0 year, Male:62/Female:18, L1/L2/L3 = 23/8/49) were enrolled. Most patients (97.5%: 78/80) could perform self-injection of ADA. Anti-TNFα agent naïve patients (N group) was 35 cases (43.8%), and switched cases from Infliximab (IFX) to ADA (S group) was 45 cases (56.2%). Loss of response for IFX (L group) in S group was 29 cases (shortened injection interval less than 7 weeks was 23 cases: 11 cases were clinical active and 12 cases were endoscopic active), and intolerant for IFX (R group) in S group was 14 cases. Clinical remission induction was significant higher in N group (100%) (P = 0.039) than R group (71.4%) and L group (70.0%) at 28 weeks, and CRP (mg/dl) was also significantly lower in N group (0.08) (P = 0.003) than R group (0.34) and L group (0.78) at 28 weeks. Endoscopic efficacy according to SES-CD was 60.9% (25/41, P = 0.057) (N group: 12, L group: 22, R group; 7), especially significant improvement was shown in N group (P = 0.003) and R group (P = 0.042). Furthermore, L group was classified into 11 clinical remission cases and 11 clinical active cases, all of them were treated with shortened IFX infusion of interval less than 7 weeks as treatment for Loss of response. The former were significantly effective for ADA switched from IFX (P = 0.002). On the other side, the latter needed more strong or additional therapy (e.g. IFX re-induction and dose escalation, or add azathioprine). The recurrence rate after 28 weeks of endoscopic effective group (20.0%, 5/25) was significantly lower endoscopic ineffective group (75.0%, 12/16) (P = 0.002).
ADA is effective not only anti-TNFα agent naïve patients as the 1st line therapy but intolerant patients for IFX. Precise endoscopic evaluation should achieve the suitable timing for switch to ADA from IFX. Endoscopic efficacy bring better prognosis than just clinical efficacy.
