Accent 2 trial

Mean total IBDQ scores in each adalimumab dosage group and the placebo group at weeks 4, 8, 12, 16, 24, 32, 40, 48, and The most frequently reported infectious adverse events were nasopharyngitis, sinusitis not otherwise specified NOS , upper respiratory tract infection NOS, and influenza. No cases of tuberculosis, coccidioidomycosis, histoplasmosis, aspergillosis, listeria, pneumocystis, or blastomycosis were reported.

One placebo patient reported a malignancy squamous cell carcinoma. No lymphomas occurred during the study, and no patients died. In the randomised cohort, larger percentages of patients randomised to placebo experienced adverse events, serious adverse events, severe adverse events, and adverse events leading to discontinuation than did patients randomised to either dosage of adalimumab. Of these , seven 2. Of the , 84 received concomitant immunosuppressants, none of whom were positive for antibodies to adalimumab.

Seven of the patients 3. Overall, there were no significant findings of clinical laboratory abnormalities, including concentrations of ANAs, and there were no correlations between laboratory findings and clinical efficacy. Of the randomised patients, those who received adalimumab were approximately 1. Again, response rates were similar between patients who received concomitant immunosuppressants and those who did not.

With either dosage, remission rates were significantly greater than for placebo at most time points after week More conclusively, the results from a large maintenance trial comparing adalimumab 40 mg every other week, adalimumab 40 mg weekly, and placebo the CHARM study 32 showed that adalimumab every other week and adalimumab weekly are equally effective in maintaining remission in patients with Crohn's disease.

The rates of serious adverse events were low in patients treated with adalimumab and were similar to placebo. No patients developed serious infectious adverse events, opportunistic infections, tuberculosis, lupus, demyelinating neurological diseases, or lymphoma; and no patients died.

However, the results for the total number of patients exposed to adalimumab show that the immunogenicity of adalimumab in patients with Crohn's disease is modest.

Adalimumab represents an important new therapeutic option for the treatment of Crohn's disease. We thank Kathleen Lomax, MD, of Abbott Laboratories for her input and feedback on the development and revision of this manuscript; Jianhua Zhong PhD, also of Abbott, for his assistance with data acquisition and management; and Michael A Nissen, ELS, Abbott, for his editorial assistance in the development and revision of this paper.

Selected investigators and Abbott staff members, including those who designed the study, analysed, and interpreted the data, wrote this manuscript, and agreed to submit this manuscript for publication. All authors, including the principal investigator WJS , approved the content of the manuscript prior to submission. National Center for Biotechnology Information , U.

Journal List Gut v. Author information Article notes Copyright and License information Disclaimer. Revised Jan 25; Accepted Jan Copyright notice. This article has been cited by other articles in PMC. Associated Data Supplementary Materials [web only appendix]. Keywords: gastroenterology, Crohn's disease, adalimumab, tumour necrosis factor antagonists, randomised controlled trial.

Efficacy and safety evaluations Patients were assessed at weeks 0, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 56, and CDAI scores were calculated for each visit.

Results Patient characteristics In all, patients participated in the study. Open in a separate window. Efficacy Randomised patients All 55 patients were included in the efficacy analyses of the randomised patient group. Supplementary Material [web only appendix] Click here to view.

Warning You have reached the maximum number of saved studies A Study of the Safety and Efficacy of Infliximab Remicade in Subjects With Fistulizing Crohn's Disease The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.

Listing a study does not mean it has been evaluated by the U. Federal Government. Read our disclaimer for details. Last Update Posted : April 27, Study Description. Detailed Description:. MedlinePlus related topics: Crohn's Disease. Drug Information available for: Infliximab. FDA Resources. Arms and Interventions. Outcome Measures. Primary Outcome Measures : Reduction in the number of draining fistulas. Secondary Outcome Measures : Complete fistula response no draining fistula.

Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Inclusion Criteria: Single or multiple draining fistulas Crohn's disease of at least 3 months' duration, Exclusion Criteria: Crohn's disease complications for which surgery might be indicated Positive stool culture.

More Information. Comparison of scheduled and episodic treatment strategies of infliximab in Crohn's disease. C-reactive protein, an indicator for maintained response or remission to infliximab in patients with Crohn's disease: a post-hoc analysis from ACCENT I. Aliment Pharmacol Ther. Epub Jan Crohn's Disease.

National Library of Medicine U. National Institutes of Health U. Department of Health and Human Services. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Crohn Disease. Drug: infliximab or placebo. Phase 3. Study Type :. Interventional Clinical Trial. Actual Enrollment :.

Study Start Date :. Actual Study Completion Date :.