The DOI matches its Crossref record; 21 of the 21 references it cites were found in a registry or an index.
Adalimumab for induction of clinical remission in moderately to severely active ulcerative colitis: results of a randomised controlled trial
Open accessAbstract
Objective: The aim of this study was to assess the efficacy and safety of adalimumab (ADA), a recombinant human monoclonal antibody against tumour necrosis factor α (TNF), for the induction of clinical remission in anti-TNF naïve patients with moderately to severely active ulcerative colitis. Methods: This 8-week, multicentre, randomised, double-blind, placebo-controlled study (NCT00385736), conducted at 94 centres in North America and Europe, enrolled ambulatory adult patients with Mayo score of ≥6 points and endoscopic subscore of ≥2 points despite treatment with corticosteroids and/or immunosuppressants. Under the original study protocol, 186 patients were randomised (1:1) to subcutaneous treatment with ADA160/80 (160 mg at week 0, 80 mg at week 2, 40 mg at weeks 4 and 6) or placebo. Subsequently, at the request of European regulatory authorities, the protocol was amended to include a second induction group (ADA80/40: 80 mg at week 0, 40 mg at weeks 2, 4 and 6). The primary efficacy endpoint was clinical remission (Mayo score ≤2 with no individual subscore >1) at week 8, assessed in 390 patients randomised (1:1:1) to ADA160/80, ADA80/40, or placebo. Safety was assessed in all enrolled patients. Patients, study site personnel, investigators, and the sponsor were blinded to treatment assignment. Results: At week 8, 18.5% of patients in the ADA160/80 group (p=0.031 vs placebo) and 10.0% in the ADA80/40 group (p=0.833 vs placebo) were in remission, compared with 9.2% in the placebo group. Serious adverse events occurred in 7.6%, 3.8% and 4.0% of patients in the placebo, ADA80/40, and ADA160/80 groups, respectively. There were two malignancies in the placebo group, none in the ADA groups. There were no cases of tuberculosis and no deaths. Conclusions: ADA160/80 was safe and effective for induction of clinical remission in patients with moderately to severely active ulcerative colitis failing treatment with corticosteroids and/or immunosuppressants. Clinical trial: NCT00385736.
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Cites
Infliximab for Induction and Maintenance Therapy for Ulcerative Colitis
Rutgeerts, P., Sandborn, W. J., Feagan, B. G., Reinisch, W., Olson, A., Johanns, J., Travers, S., Rachmilewitz, D., Hanauer, S. B., Lichtenstein, G. R., et al. (2005) · New England Journal of Medicine · doi:10.1056/nejmoa050516 · Cited by 3,902
Self-citationTargan, S. R., Hanauer, S. B., van Deventer, S. J. H., Mayer, L., Present, D. H., Braakman, T., DeWoody, K. L., Schaible, T. F., & Rutgeerts, P. J. (1997) · New England Journal of Medicine · doi:10.1056/nejm199710093371502 · Cited by 3,135
Self-citationCoated Oral 5-Aminosalicylic Acid Therapy for Mildly to Moderately Active Ulcerative Colitis
Schroeder, K. W., Tremaine, W. J., & Ilstrup, D. M. (1987) · New England Journal of Medicine · doi:10.1056/nejm198712243172603 · Cited by 3,026
Colombel, J., Sandborn, W. J., Rutgeerts, P., Enns, R., Hanauer, S. B., Panaccione, R., Schreiber, S., Byczkowski, D., Li, J., Kent, J. D., et al. (2007) · Gastroenterology · doi:10.1053/j.gastro.2006.11.041 · Cited by 2,245
Self-citationHanauer, S. B., Sandborn, W. J., Rutgeerts, P., Fedorak, R. N., Lukas, M., MacIntosh, D., Panaccione, R., Wolf, D., & Pollack, P. (2006) · Gastroenterology · doi:10.1053/j.gastro.2005.11.030 · Cited by 1,715
Self-citationBiological, clinical, and ethical advances of placebo effects
Finniss, D. G., Kaptchuk, T. J., Miller, F., & Benedetti, F. (2010) · The Lancet · doi:10.1016/s0140-6736(09)61706-2 · Cited by 1,272
Järnerot, G., Hertervig, E., Friis-Liby, I., Blomquist, L., Karlén, P., Grännö, C., Vilien, M., Ström, M., Danielsson, Å., Verbaan, H., et al. (2005) · Gastroenterology · doi:10.1053/j.gastro.2005.03.003 · Cited by 1,089
Sandborn, W. J., Rutgeerts, P., Enns, R., Hanauer, S. B., Colombel, J.-F., Panaccione, R., D'Haens, G., Li, J., Rosenfeld, M. R., Kent, J. D., et al. (2007) · Annals of Internal Medicine · doi:10.7326/0003-4819-146-12-200706190-00159 · Cited by 965
Self-citationTreatment of Ulcerative Colitis with a Humanized Antibody to the α 4 β 7 Integrin
Feagan, B. G., Greenberg, G. R., Wild, G., Fedorak, R. N., Paré, P., McDonald, J. W. D., Dubé, R., Cohen, A., Steinhart, A. H., Landau, S., et al. (2005) · New England Journal of Medicine · doi:10.1056/nejmoa042982 · Cited by 692
Self-citationTumour necrosis factor alpha in stool as a marker of intestinal inflammation
Braegger, C. P., Nicholls, S., Murch, S. H., MacDonald, T. T., & Stephens, S. (1992) · The Lancet · doi:10.1016/0140-6736(92)90999-j · Cited by 683
Cited by
Lamb, C. A., Kennedy, N. A., Raine, T., Hendy, P. A., Smith, P. J., Limdi, J. K., Hayee, B., Lomer, M. C. E., Parkes, G. C., Selinger, C., et al. (2019) · Gut · doi:10.1136/gutjnl-2019-318484 · Cited by 2,346
Ordás, I., Eckmann, L., Talamini, M., Baumgart, D. C., & Sandborn, W. J. (2012) · The Lancet · doi:10.1016/s0140-6736(12)60150-0 · Cited by 2,078
Self-citationLe Berre, C., Honap, S., & Peyrin-Biroulet, L. (2023) · The Lancet · doi:10.1016/s0140-6736(23)00966-2 · Cited by 1,643
Dignass, A., Lindsay, J. O., Sturm, A., Windsor, A., Colombel, J.-F., Allez, M., D'Haens, G., D'Hoore, A., Mantzaris, G., Novacek, G., et al. (2012) · Journal of Crohn's and Colitis · doi:10.1016/j.crohns.2012.09.002 · Cited by 1,548
Self-citationMoayyedi, P., Surette, M. G., Kim, P. T., Libertucci, J., Wolfe, M., Onischi, C., Armstrong, D., Marshall, J. K., Kassam, Z., Reinisch, W., et al. (2015) · Gastroenterology · doi:10.1053/j.gastro.2015.04.001 · Cited by 1,499
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Metadata
- Authors
- Reinisch, W., Sandborn, W. J., Hommes, D. W., D'Haens, G., Hanauer, S., Schreiber, S., Panaccione, R., Fedorak, R. N., Tighe, M. B., Huang, B., Kampman, W., Lazar, A., & Thakkar, R.
- Venue
- Gut
- Publisher
- BMJ
- Published
- 2011-01-05
- Volume
- 60
- Issue
- 6
- Pages
- 780-787
- ISSN
- 0017-5749 (ISSN-L)
- 1468-3288
- OpenAlex
- W2146692972
- Cited by
- 892
- References
- 21
- FWCI
- 37.82
- Type
- journal article
- Language
- en
- Open access
- bronze
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- Reinisch, W., Sandborn, W. J., Hommes, D. W., D'Haens, G., Hanauer, S., Schreiber, S., Panaccione, R., Fedorak, R. N., Tighe, M. B., Huang, B., Kampman, W., Lazar, A., & Thakkar, R. (2011). Adalimumab for induction of clinical remission in moderately to severely active ulcerative colitis: results of a randomised controlled trial. Gut. https://doi.org/10.1136/gut.2010.221127
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.
