{"corpus_id":75311601,"paper_sha":"a32002f32232beb356fb8538513de07f897180b4","doi":"10.1056/NEJM199710093371502","arxiv_id":null,"pmid":null,"pmcid":null,"mag_id":2321453230,"dblp_id":null,"acl_id":null,"title":"A Short-Term Study of Chimeric Monoclonal Antibody cA2 to Tumor Necrosis Factor α for Crohn's Disease","year":1997,"publication_date":"1997-10-09","venue":"","journal":{"name":"The New England Journal of Medicine","pages":"1029-1035","volume":"337"},"journal_issn":null,"journal_title":null,"publication_types":[],"pubmed_pub_types":null,"s2_fields_of_study":["Medicine"],"reference_count":32,"citation_count":2888,"influential_citation_count":18,"is_open_access":true,"arxiv_categories":null,"arxiv_license":null,"arxiv_journal_ref":null,"mesh_headings":null,"chemicals":null,"comments_corrections":null,"source_flags":1,"s2_open_access_pdf_url":"https://www.nejm.org/doi/pdf/10.1056/NEJM199710093371502?articleTools=true","s2_open_access_landing_url":"https://www.semanticscholar.org/paper/a32002f32232beb356fb8538513de07f897180b4","s2_open_access_license":null,"s2_open_access_status":"BRONZE","pmc_open_access_pdf_url":null,"pmc_open_access_landing_url":null,"pmc_open_access_license":null,"pmc_open_access_status":null,"unpaywall_open_access_pdf_url":null,"unpaywall_open_access_landing_url":null,"unpaywall_open_access_license":null,"unpaywall_open_access_status":null,"abstract":"BACKGROUND: Studies in animals and an open-label trial have suggested a role for antibodies to tumor necrosis factor alpha, specifically chimeric monoclonal antibody cA2, in the treatment of Crohn's disease. METHODS: We conducted a 12-week multicenter, double-blind, placebo-controlled trial of cA2 in 108 patients with moderate-to-severe Crohn's disease that was resistant to treatment. All had scores on the Crohn's Disease Activity Index between 220 and 400 (scores can range from 0 to about 600, with higher scores indicating more severe illness). Patients were randomly assigned to receive a single two-hour intravenous infusion of either placebo or cA2 in a dose of 5 mg per kilogram of body weight, 10 mg per kilogram, or 20 mg per kilogram. Clinical response, the primary end point, was defined as a reduction of 70 or more points in the score on the Crohn's Disease Activity Index at four weeks that was not accompanied by a change in any concomitant medications. RESULTS: At four weeks, 81 percent of the patients given 5 mg of cA2 per kilogram (22 of 27 patients), 50 percent of those given 10 mg of cA2 per kilogram (14 of 28), and 64 percent of those given 20 mg of cA2 per kilogram (18 of 28) had had a clinical response, as compared with 17 percent of patients in the placebo group (4 of 24) (p<0.001 for the comparison of the cA2 group as a whole with placebo). Thirty-three percent of the patients given cA2 went into remission (defined as a score below 150 on the Crohn's Disease Activity Index), as compared with 4 percent of the patients given placebo (P=0.005). At 12 weeks, 41 percent of the cA2-treated patients (34 of 83) had had a clinical response, as compared with 12 percent of the patients in the placebo group (3 of 25) (P=0.008). The rates of adverse effects were similar in the groups. CONCLUSIONS: A single infusion of cA2 was an effective short-term treatment in many patients with moderate-to-severe, treatment-resistant Crohn's disease.","claims":[{"public_id":"cl_465a97d2d0fc03170dfc7a2f2b972a0a","status":"active","text":"A single intravenous infusion of cA2 produced substantially higher four-week clinical response rates than placebo in moderate-to-severe treatment-resistant Crohn's disease.","confidence":0.99,"contributors":[{"id":1,"public_id":"12632b8b5f","public_label":"Anonymous (12632b8b5f)","roles":["extraction"],"url":"https://sah.borca.ai/u/12632b8b5f"}],"url":"https://sah.borca.ai/claims/cl_465a97d2d0fc03170dfc7a2f2b972a0a"},{"public_id":"cl_eb34dac5c835591d64574fc128493a4f","status":"active","text":"Adverse-effect rates were similar between cA2 and placebo groups.","confidence":0.96,"contributors":[{"id":1,"public_id":"12632b8b5f","public_label":"Anonymous (12632b8b5f)","roles":["extraction"],"url":"https://sah.borca.ai/u/12632b8b5f"}],"url":"https://sah.borca.ai/claims/cl_eb34dac5c835591d64574fc128493a4f"},{"public_id":"cl_c8a0c2b95de260ad48998a5042504663","status":"active","text":"Clinical response persisted at 12 weeks in a larger proportion of cA2-treated patients than in the placebo group.","confidence":0.97,"contributors":[{"id":1,"public_id":"12632b8b5f","public_label":"Anonymous (12632b8b5f)","roles":["extraction"],"url":"https://sah.borca.ai/u/12632b8b5f"}],"url":"https://sah.borca.ai/claims/cl_c8a0c2b95de260ad48998a5042504663"},{"public_id":"cl_331fb42b16e2e061fa248eb89f0b7a42","status":"active","text":"cA2 also yielded a higher remission rate than placebo at four weeks.","confidence":0.98,"contributors":[{"id":1,"public_id":"12632b8b5f","public_label":"Anonymous (12632b8b5f)","roles":["extraction"],"url":"https://sah.borca.ai/u/12632b8b5f"}],"url":"https://sah.borca.ai/claims/cl_331fb42b16e2e061fa248eb89f0b7a42"}],"concepts":[{"public_id":"co_1ba7956fde9d2e85f29784e22e7d88bc","status":"active","name":"placebo","description":"An inactive comparator used to assess the effect of cA2.","types":["comparator"],"aliases":[],"contributors":[{"id":1,"public_id":"12632b8b5f","public_label":"Anonymous (12632b8b5f)","roles":["extraction"],"url":"https://sah.borca.ai/u/12632b8b5f"}],"url":"https://sah.borca.ai/concepts/co_1ba7956fde9d2e85f29784e22e7d88bc"},{"public_id":"co_2cfa5682f5f1f5f2afee50f56b479bd4","status":"active","name":"moderate-to-severe treatment-resistant Crohn's disease","description":"Crohn's disease that was severe enough to meet the trial's inclusion criteria and resistant to prior treatment.","types":["patient population","disease subtype"],"aliases":[],"contributors":[{"id":1,"public_id":"12632b8b5f","public_label":"Anonymous (12632b8b5f)","roles":["extraction"],"url":"https://sah.borca.ai/u/12632b8b5f"}],"url":"https://sah.borca.ai/concepts/co_2cfa5682f5f1f5f2afee50f56b479bd4"},{"public_id":"co_519269fc761d2421222a10b7de7c3605","status":"active","name":"chimeric monoclonal antibody cA2","description":"A chimeric monoclonal antibody directed against tumor necrosis factor alpha and tested as a treatment for Crohn's disease.","types":["drug","therapeutic antibody"],"aliases":["cA2"],"contributors":[{"id":1,"public_id":"12632b8b5f","public_label":"Anonymous (12632b8b5f)","roles":["extraction"],"url":"https://sah.borca.ai/u/12632b8b5f"}],"url":"https://sah.borca.ai/concepts/co_519269fc761d2421222a10b7de7c3605"},{"public_id":"co_67490444459e9d30000e97f531766f1b","status":"active","name":"Crohn's Disease Activity Index","description":"A clinical score used to quantify Crohn's disease severity and treatment response.","types":["measurement scale","clinical index"],"aliases":["CDAI"],"contributors":[{"id":1,"public_id":"12632b8b5f","public_label":"Anonymous (12632b8b5f)","roles":["extraction"],"url":"https://sah.borca.ai/u/12632b8b5f"}],"url":"https://sah.borca.ai/concepts/co_67490444459e9d30000e97f531766f1b"},{"public_id":"co_7b8c4d5d73381dbe60954c5d07f78342","status":"active","name":"Crohn's disease","description":"An inflammatory bowel disease studied here in moderate-to-severe, treatment-resistant patients.","types":["disease"],"aliases":[],"contributors":[{"id":1,"public_id":"12632b8b5f","public_label":"Anonymous (12632b8b5f)","roles":["extraction"],"url":"https://sah.borca.ai/u/12632b8b5f"}],"url":"https://sah.borca.ai/concepts/co_7b8c4d5d73381dbe60954c5d07f78342"},{"public_id":"co_7c99d0e1d114f57ba250e61938f6b49b","status":"active","name":"clinical response","description":"The primary endpoint defined by a reduction of at least 70 points in the Crohn's Disease Activity Index without concomitant medication changes.","types":["outcome"],"aliases":[],"contributors":[{"id":1,"public_id":"12632b8b5f","public_label":"Anonymous (12632b8b5f)","roles":["extraction"],"url":"https://sah.borca.ai/u/12632b8b5f"}],"url":"https://sah.borca.ai/concepts/co_7c99d0e1d114f57ba250e61938f6b49b"},{"public_id":"co_91f54db4b44984aeeeda0443831ca1ba","status":"active","name":"tumor necrosis factor alpha","description":"A cytokine targeted by cA2 in the treatment intervention.","types":["cytokine"],"aliases":["TNF alpha","TNF-α","TNFα"],"contributors":[{"id":1,"public_id":"12632b8b5f","public_label":"Anonymous (12632b8b5f)","roles":["extraction"],"url":"https://sah.borca.ai/u/12632b8b5f"}],"url":"https://sah.borca.ai/concepts/co_91f54db4b44984aeeeda0443831ca1ba"},{"public_id":"co_9e33830c8a31984b1e3d5a18602db04e","status":"active","name":"remission","description":"A disease state defined here as a Crohn's Disease Activity Index score below 150.","types":["outcome"],"aliases":[],"contributors":[{"id":1,"public_id":"12632b8b5f","public_label":"Anonymous (12632b8b5f)","roles":["extraction"],"url":"https://sah.borca.ai/u/12632b8b5f"}],"url":"https://sah.borca.ai/concepts/co_9e33830c8a31984b1e3d5a18602db04e"},{"public_id":"co_ad9f7fe26185dab817da26e1ddf309ca","status":"active","name":"multicenter, double-blind, placebo-controlled trial","description":"A randomized clinical trial design comparing cA2 with placebo across multiple centers.","types":["study design","clinical trial design"],"aliases":[],"contributors":[{"id":1,"public_id":"12632b8b5f","public_label":"Anonymous (12632b8b5f)","roles":["extraction"],"url":"https://sah.borca.ai/u/12632b8b5f"}],"url":"https://sah.borca.ai/concepts/co_ad9f7fe26185dab817da26e1ddf309ca"},{"public_id":"co_ee36c221cb0c42cfe963d9bbfaada624","status":"active","name":"adverse effects","description":"Undesired treatment-related events monitored for safety in the trial.","types":["safety outcome"],"aliases":[],"contributors":[{"id":1,"public_id":"12632b8b5f","public_label":"Anonymous (12632b8b5f)","roles":["extraction"],"url":"https://sah.borca.ai/u/12632b8b5f"}],"url":"https://sah.borca.ai/concepts/co_ee36c221cb0c42cfe963d9bbfaada624"}],"external_ids":{"DOI":"10.1056/NEJM199710093371502","ArXiv":null,"PubMed":null,"PubMedCentral":null,"MAG":2321453230,"DBLP":null,"ACL":null},"open_access":{"is_open_access":true,"pdf_url":"https://www.nejm.org/doi/pdf/10.1056/NEJM199710093371502?articleTools=true","landing_url":"https://www.semanticscholar.org/paper/a32002f32232beb356fb8538513de07f897180b4","source":"semantic_scholar","pdf_url_source":"semantic_scholar_open_access_pdf","license":null,"status":"BRONZE","reason":null},"reference_availability":{"status":"available","references_indexed":true,"full_text_available":false,"full_text_source":null,"count_basis":"semantic_scholar_metadata","extraction_status":"not_applicable","reason":null},"source":{"provider":"episteme2","base_corpus":"semantic_scholar_dump","freshness_mode":"unknown","basis":["semantic_scholar_metadata","postgres_metadata"],"limits":["paper metadata is based on indexed upstream scholarly datasets","claims and concepts are available only for extracted papers","absence of claims or concepts means no extracted graph data is available in this response"],"status":"available","degraded":false,"degraded_reasons":[],"diagnostics":{"status":"available","degraded":false,"degraded_reasons":[],"metadata_status":"available","graph_status":"available","abstract_status":"available"},"source_flags":1},"paper_id":634636,"paper_uid":"8d5db8ae-c465-451a-93b6-d5567695f1e5","canonical_identity":{"paper_id":634636,"paper_uid":"8d5db8ae-c465-451a-93b6-d5567695f1e5","identity_status":"available","lookup_basis":"semantic_scholar_external_id","compatibility_path":"corpus_id"},"url":"https://sah.borca.ai/papers/75311601"}