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Meta-Analysis
. 2017 Sep 8;9(9):CD011572.
doi: 10.1002/14651858.CD011572.pub2.

Placebo response and remission rates in randomised trials of induction and maintenance therapy for ulcerative colitis

Vipul Jairath  1 , G Y Zou, Claire E Parker, John K MacDonald, Turki AlAmeel, Mohammad Al Beshir, Majid A Almadi, Talal Al-Taweel, Nathan Ss Atkinson, Sujata Biswas, Thomas Chapman, Parambir S Dulai, Mark A Glaire, Daniël R Hoekman, Andreas Koutsoumpas, Elizabeth Minas, Mahmoud H Mosli, Mark Samaan, Reena Khanna, Simon Travis, Geert D'Haens, William J Sandborn, Brian G Feagan
Affiliations
Meta-Analysis

Placebo response and remission rates in randomised trials of induction and maintenance therapy for ulcerative colitis

Vipul Jairath et al. Cochrane Database Syst Rev. .

Abstract

Background: It is important to minimize placebo rates in randomised controlled trials (RCTs) to efficiently detect treatment differences between interventions. Historically, high placebo rates have been observed in clinical trials of ulcerative colitis (UC). A better understanding of factors influencing placebo rates may lead to more informed clinical trial design.

Objectives: A systematic review and meta-analysis was conducted to evaluate placebo response and remission rates in RCTs evaluating UC treatments in adult patients.

Search methods: Electronic databases (i.e. MEDLINE, EMBASE, and CENTRAL) were searched from inception to 1 March 2017 with no language restrictions applied. Reference lists and conference proceedings of major gastroenterology meetings were also handsearched to identify additional studies.

Selection criteria: Placebo-controlled RCTs of adult patients with UC treated with corticosteroids, aminosalicylates, immunosuppressives or biologics were eligible, provided enrolment and outcome assessment was conducted using the Ulcerative Colitis Disease Activity Index (UCDAI) or the Mayo Clinic Score. The minimum trial duration was two weeks for induction trials and four months maintenance trials.

Data collection and analysis: Pairs of authors independently determined study eligibility and extracted data with any disagreements resolved through consensus. Outcomes of interest included the proportion of patients with clinical response and remission. Trial characteristics such as the design, participant demographics and disease history, interventions, and enrolment and assessment criteria were also recorded. The methodological quality of the included studies was evaluated using the Cochrane risk of bias tool. Pooled placebo response and remission rates and 95% confidence intervals (95% CI) were calculated using a binomial normal model for proportions. Induction of remission and maintenance studies were pooled separately. The impact of study-level characteristics on placebo response and remission rates was investigated using mixed-effects meta-regression analyses with logits of event rates as the outcome variables. An assessment of pooled placebo rates over time was conducted using a cumulative meta-analysis based on date of publication. Publication bias was examined using funnel plots.

Main results: The screening process identified 61 included studies which encompass 58 induction phases (5111 patients randomised to placebo) and 12 maintenance phases (1579 patients randomised to placebo). For induction trials, the pooled estimate of placebo response was 33% (95% CI 30% to 36%) while the pooled estimate of placebo remission was 12% (95% CI 9% to 15%). For maintenance trials, the pooled estimate of placebo response was 23% (95% CI 19% to 28%) while the pooled estimate of placebo remission was 17% (95% CI 10% to 27%).Studies enrolling patients with more active disease confirmed objectively by endoscopy were associated with significantly lower placebo remission and response rates than trials enrolling patients with less active disease (27% versus 4%, OR 2.60, 95% CI 1.25 to 5.42, P = 0.01 for UCDAI endoscopy sub score ≥1 versus ≥ 2 for remission; and 27% versus 4%, OR 1.70, 95% CI 1.02 to 2.82, P = 0.02 for UCDAI endoscopy sub score greater than or equal to one versus greater than or equal to two for response). With respect to drug class, the lowest placebo response and remission rates were observed in trials evaluating corticosteroids (23%; 95% CI 19 to 29%, and 5%; 95% CI 2 to 11%, respectively). Trials of biologics had the highest placebo response rate (35%; 95% CI 30 to 41%), while trials evaluating aminosalicylates had the highest placebo remission rate (18%; 95% CI 12 to 24%). Disease duration of greater than five years prior to enrolment was associated with a significantly lower placebo response rate compared to disease duration of less than or equal to five years (29% versus 47%, respectively; OR 0.54, 95% CI 0.32 to 0.92, P = 0.02). The requirement of a minimum rectal bleeding score for study eligibility was associated with an increased placebo response rate compared to studies that did not use rectal bleeding for trial eligibility (37% versus 32%, respectively; OR 1.70, 95% CI 1.02 to 2.82, P = 0.02). Finally, the time point of primary outcome assessment was found to be significantly associated with placebo remission rates such that every one week increment in endpoint assessment was associated with a 6% increase in the placebo remission rate (OR 1.06, 95% CI 1.02 to 1.10, P = 0.01).Cumulative meta-analysis indicated a consistent increase in the placebo response rate from 1987 to 2007 (from 13% to 33%), although rates have remained constant from 2008 to 2015 (32% to 34%). Similarly, placebo remission rates increased from 1987 to 2007 (5% to 14%) but have remained constant from 2008 to 2015 (12 to 14%). On meta-regression, there were no statistically significant differences between the 1987-2007 and 2008-2015 point estimates for both response (P = 0.81) and remission (P = 0.32).

Authors' conclusions: Placebo response and remission rates vary according to endoscopic disease severity and rectal bleeding score at trial entry, class of agent, disease duration, and the time point at which the primary outcome was measured. These observations have important implications for the design and conduct of future clinical trials in UC and will help researchers design trials, determine required sample sizes and also provide useful information about trial design features which should be considered when planning new trials.

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Conflict of interest statement

Vipul Jairath has received consulting fees from Sandoz, Takeda, Abbvie, Janssen; and speakers fees from Takeda, Abbvie, Ferring, Janssen All of these financial activities are outside of the submitted work.

GY Zou: None known

Claire E Parker: None known

John K MacDonald: None known

Turki AlAmeel: None known

Mohammad Al Beshir: None known

Majid A Almadi: None known

Talal Al‐Taweel has received consulting fees from AbbVie and Takeda; and lecture fees from Abbvie and Janssen and travel/accommodations/meeting expenses from Abbvie, Janssen, Novartis, Newbridge and Takeda. All of these financial activities are outside the submitted work.

Nathan Atkinson has received funds from AbbVie for travel/accommodations/meeting expenses. All of these financial activities are outside the submitted work.

Sujata Biswas: None known

Thomas Chapman has received support for a DPhil in Biomedical and Clinical Sciences from the Wellcome Trust and Oxford BRC. The topic of study relates to the immunology of Crohn's disease. Dr Chapman has no other known declarations of interest.

Parambir Dulai has received consulting fees from Takeda, research support (grants/grants pending) from Takeda and Pfizer; and payment for lectures from Takeda. All of these financial activities are outside of the submitted work.

Mark A Glaire: None known

Daniël R Hoekman: None known

Andreas Koutsoumpas: None known

Elizabeth MInas: None known

Mahmoud H Mosli: None known

Mark Samaan: None known

Reena Khanna has received honoraria from AbbVie, Jansen, Pfizer, Shire, and Takeda for consultancy. All of these financial activities are outside of the submitted work.

Simon Travis declined commercial consultancy or speaking engagements to avoid any perception of a conflict of interest as President of ECCO 2012‐2014. Since then he has received fees for consulting from AbbVie, Astra Zeneca, Celgene, Falk, Ferring, GSK, Janssen, Merck (to the Institution), Novartis, Novo Nordisk (both self and Institution), NPS Pharmaceuticals, Pfizer, Proximagen, Takeda, Topivert, Vertex (to the Institution), Warner‐Chilcott Amgen, Biogen, Boehringer Ingelheim, Bristol‐Myers Squibb, Cosmo, Lilly, Neovacs, Shire, Sigmoid Pharma, UCB, VHsquared and Vifor; lecture fee(s) from AbbVie, Ferring, Takeda, Amgen, Biogen, fee(s) for expert testimony to the FDA and EMA from Cosmo Technologies and Santarus; royalties from Wiley Blackwel, Elsevier and Oxford University Press for books; and funding from Schering Plough, Procter & Gamble, Merck and AbbVie for part salary for a nurse involved in therapeutic education. All of these financial activities are outside of the submitted work.

Geert D’Haens has received consulting fees from Abbvie, Ablynx, Actogenix, Amgen, AM Pharma, AstraZeneca, Boerhinger Ingelheim, Cosmo, Ferring, DrFALK Pharma, Celgene, Celltrion, Centocor/Jansen Biologics, Engene, Galapagos, Giuliani, GSK, Hospira, Millenium/Takeda, Mitsubishi Pharma, MSD, Mundipharma, Novonordisk, Pfizer, Prometheus Laboratories, Receptos, Salix, Sandoz, SetpointShire, TEVA, Tigenix, Tillotts, and Versant; he has received grants/has grants pending from Abbvie, MSD, Takeda, GSK, GivenImaging and Photopill; he has received payment for lectures from Abbvie, Ferring, Centocor/Jansen Biologics, Millenium/Takeda, MSD, Shire, and Tillotts; he has stock options with Engene. All of these financial activities are outside the submitted work.

William Sandborn has received consultancy fees from Abbott Laboratories, ActoGeniX NV, AGI Therapeutics, Inc., Alba Therapeutics Corporation, Albireo, Alfa Wasserman, Amgen, AM‐Pharma BV, Anaphore, Astellas Pharma, Athersys, Inc., Atlantic Healthcare Limited, Axcan Pharma (now Aptalis), BioBalance Corporation, Boehringer‐Ingelheim Inc, Bristol Meyers Squibb: (both money paid to WS and institution), Celegene, Celek Pharmaceuticals, Cellerix SL, Cerimon Pharmaceuticals, ChemoCentryx, CoMentis, Cosmo Technologies, Coronado Biosciences, Cytokine Pharmasciences, Eagle Pharmaceuticals, Eisai Medical Research Inc., Elan Pharmaceuticals: (both money paid to WS and institution), EnGene, Inc., Eli Lilly, Enteromedics: (both money paid to WS and institution), Exagen Diagnostics, Inc., Ferring Pharmaceuticals, Flexion Therapeutics, Inc., Funxional Therapeutics Limited, Genzyme Corporation, Genentech (now Roche): (both money paid to WS and institution), Gilead Sciences, Given Imaging, Glaxo Smith Kline, Human Genome Sciences, Ironwood Pharmaceuticals (previously Microbia Inc.), Janssen (previously Centocor): (both money paid to WS and institution), KaloBios Pharmaceuticals, Inc., Lexicon Pharmaceuticals, Lycera Corporation, Meda Pharmaceuticals (previously Alaven Pharmaceuticals), Merck Research Laboratories, MerckSerono, Millennium Pharmaceuticals (subsequently merged with Takeda): (both money paid to WS and institution), Nisshin Kyorin Pharmaceuticals Co., Ltd., Novo Nordisk A/S, NPS Pharmaceuticals, Optimer Pharmaceuticals, Orexigen Therapeutics, Inc., PDL Biopharma: (money paid to institution), Pfizer: (both money paid to WS and institution), Procter and Gamble: (both money paid to WS and institution), Prometheus Laboratories, ProtAb Limited, Purgenesis Technologies, Inc., Relypsa, Inc., Salient Pharmaceuticals, Salix Pharmaceuticals, Inc., Santarus, Schering Plough Corporation (acquired by Merck), Shire Pharmaceuticals: (money paid to institution), Sigmoid Pharma Limited, Sirtris Pharmaceuticals, Inc. (a GSK company), S.L.A. Pharma (UK) Limited, Takeda: (both money paid to WS and institution), Targacept, Teva Pharmaceuticals, Therakos, Tillotts Pharma AG (acquired by Zeria Pharmaceutical Co., Ltd), TxCell SA, UCB Pharma: (both money paid to WS and institution), Viamet Pharmaceuticals, Vascular Biogenics Limited (VBL), Warner Chilcott UK Limited, Wyeth (now Pfizer); fees for expert testimony: Dickinson, Prud'Homme, Adams & Ingram; Grants/Grants Pending: Abbott Laboratories, Bristol Meyers Squibb, Genentech, Glaxo Smith Kline, Janssen (previously Centocor), Millennium Pharmaceuticals (now Takeda), Novartis, Pfizer, Procter and Gamble Pharmaceuticals, Shire Pharmaceuticals, UCB Pharma; payment for lectures: Abbott Laboratories, Bristol Meyers Squibb, Janssen (previously Centocor); patents: Sandborn WJ. Use of topical azathioprine to treat inflammatory bowel disorders. United States patent number: 5,691,343. Date of patent: November 25, 1997; Sandborn WJ, Rhodes J. Colonic delivery of nicotine to treat inflammatory bowel disease. South African patent number: 97/1020. Date of patent: January 28, 1998; Sandborn WJ. Use of azathioprine to treat Crohn's disease. United States patent number: 5,733,915. Date of patent: March 31, 1998; Sandborn WJ, Rhodes J. Colonic delivery of nicotine to treat inflammatory bowel disease. United States patent number: 5,846,983. Date of patent: December 8, 1998; Sandborn WJ. Azathioprine compositions for colonic administration. New Zealand patent number: 306062. Date of Patent: February 11, 1999; Sandborn WJ. Azathioprine compositions for colonic administration. Singapore patent number: 45647. Date of Patent: March 14, 1999; Sandborn WJ, Rhodes J, Rhodes P, Evans BK. Colonic delivery of nicotine to treat inflammatory bowel disease. United States patent number: 5,889,028. Date of patent: March 30, 1999; Sandborn WJ. Topical formulations of azathioprine to treat inflammatory bowel disorders. United States patent number: 5,905,081. Date of Patent: May 18, 1999; Sandborn WJ. Azathioprine compositions for colonic administration. Australia patent number: 707168. Date of Patent: October 14, 1999; Sandborn WJ, Rhodes J, Evans BK. Intestinal absorption of nicotine to treat nicotine responsive conditions. Australia patent number: 718052. Date of patent: July 20, 2000; Sandborn WJ, Rhodes J. Colonic delivery of nicotine to treat inflammatory bowel disease. United States patent number: 6,166,044. Date of patent: December 26, 2000; Sandborn WJ. Use of topical azathioprine and thioguanine to treat colorectal adenomas. United States patent number: 6,166,024. Date of patent: December 26, 2000; Rhodes J, Evans BK, Rhodes P, Sandborn WJ. Intestinal absorption of nicotine to treat nicotine responsive conditions. United States patent number: 6,238,689. Date of patent: May 29, 2001; Sandborn, WJ. Azathioprine compositions for colonic administration. Czech Republic patent number: 290428. Date of patent: May 27, 2002; Sandborn, WJ, Rhodes J. Colonic delivery of nicotine to treat IBD. Mexico patent number: 209636. Date of Patent August 12, 2002; Sandborn WJ. Enema and enterically‐coated oral dosage forms of azathioprine. United States Patent No.: 6,432,967. Date of patent: August 13, 2002; Sandborn WJ, Rhodes J. Colonic delivery of nicotine to treat nicotine responsive conditions. Europe patent number: 0954337. Date of patent: November 2, 2002; Sandborn WJ, Rhodes J, Rhodes P, Evans BK. Colonic delivery of nicotine to treat IBD. Europe patent number: 893998. Date of patent: April 15, 2003; Sandborn WJ, Rhodes J, Rhodes P, Evans BK. Colonic delivery of nicotine to treat inflammatory bowel disease. Hong Kong patent number: HK1019043. Date of patent: August 1, 2003; Sandborn WJ, Rhodes J, Rhodes P, Evans BK. Colonic delivery of nicotine to treat IBD. China patent number: ZL97192177. Date of patent: November 12, 2003; Sandborn W, Rhodes J, Rhodes P, Evans B. Colonic delivery of nicotine to treat inflammatory bowel disease. Czech patent number: 293616. Patent date: 2004; Rhodes J, Sandborn WJ, Rhodes P, Evans BK. Colonic deliver of nicotine to treat inflammatory bowel disease. Canada patent number: 2,246,235. Patent date: 2007; Sachetto JP, Sandborn WJ, Tremaine WJ. Pharmaceutical composition for the treatment of inflammatory bowel disease. United States patent number: 7341741. Patent date 2008; Rhodes J, Evans BK, Rhodes P, Sandborn WJ. Intestinal absorption of nicotine to treat nicotine responsive conditions. Canadian patent number: 2,260,909. Patent date 2008; Levy MJ, Camilleri ML, Murray JA, Sandborn WJ. Obesity treatment and device. United States patent number: 7,803,195 B2. Date of patent September 28, 2010; Dr Sandborn has stock options with Enteromedics. All of these financial activities are outside of the submitted work.

Brian Feagan has received fee(s) from Abbott/AbbVie, Amgen, Astra Zeneca, Avaxia Biologics Inc., Bristol‐Myers Squibb, Celgene, Centocor Inc., Elan/Biogen, Ferring, JnJ/Janssen, Merck, Novartis, Novonordisk, Pfizer, Prometheus Laboratories, Protagonist, Salix Pharma, Takeda, Teva, Tillotts Pharma AG, UCB Pharma for Board membership; fee(s) from Abbott/AbbVie, Actogenix, Albireo Pharma, Amgen, Astra Zeneca, Avaxia Biologics Inc., Axcan, Baxter Healthcare Corp., Boehringer‐Ingelheim, Bristol‐Myers Squibb, Calypso Biotech, Celgene, Elan/Biogen, EnGene, Ferring Pharma, Roche/Genentech, GiCare Pharma, Gilead, Given Imaging Inc., GSK, Ironwood Pharma, Janssen Biotech (Centocor), JnJ/Janssen, Kyowa Kakko Kirin Co Ltd., Lexicon, Lilly, Merck, Millennium, Nektar, Novonordisk, Pfizer, Prometheus Therapeutics and Diagnostics, Protagonist, Receptos, Salix Pharma, Serono, Shire, Sigmoid Pharma, Synergy Pharma Inc., Takeda, Teva Pharma, Tillotts, UCB Pharma, Vertex Pharma, Warner‐Chilcott, Wyeth, Zealand, and Zyngenia for consultancy; and lecture fee(s) from: Abbott/AbbVie, JnJ/Janssen, Takeda, Warner‐Chilcott, and UCB Pharma. All of these activities are outside the submitted work.

Figures

1
1
Study flow diagram.
2
2
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
3
3
Response rates in induction phases.
4
4
Remission rates in induction phases.
5
5
Response rates in maintenance phases.
6
6
Remission rates in maintenance phases.
7
7
Cumulative placebo response rates 1987‐2015.
8
8
Cumulative placebo remission rates 1987‐2015.
9
9
Funnel plot test for asymmetry: response
10
10
Funnel plot test for asymmetry: remission
See this image and copyright information in PMC

Update of

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    1. Rubin DT, Cohen RD, Sandborn WJ, Lichtenstein GR, Axler J, Riddell R, et al. Budesonide MMX 9 mg for inducing remission in patients with Mild‐to‐Moderate ulcerative colitis not adequately controlled with oral 5‐ASAs. Journal of Crohn's and Colitis 2015;9:S7.
Rutgeerts 2005a {published data only}
    1. Rutgeerts P, Sandborn WJ, Feagan BG, Reinisch W, Olson A, Johanns J, et al. Infliximab for induction and maintenance therapy for ulcerative colitis. New England Journal of Medicine 2005; Vol. 353:2462‐76. - PubMed
Rutgeerts 2005b {published data only}
    1. Rutgeerts P, Sandborn WJ, Feagan BG, Reinisch W, Olson A, Johanns J, et al. Infliximab for induction and maintenance therapy for ulcerative colitis. New England Journal of Medicine 2005; Vol. 353:2462‐76. - PubMed
Rutgeerts 2013a {published data only}
    1. Rutgeerts PJ, Fedorak RN, Hommes DW, Sturm A, Baumgart DC, Bressler B, et al. A randomised phase I study of etrolizumab (rhuMAb beta7) in moderate to severe ulcerative colitis. Gut 2013; Vol. 62:1122‐30. - PMC - PubMed
Rutgeerts 2013b {published data only}
    1. Rutgeerts PJ, Fedorak RN, Hommes DW, Sturm A, Baumgart DC, Bressler B, et al. A randomised phase I study of etrolizumab (rhuMAb beta7) in moderate to severe ulcerative colitis. Gut 2013; Vol. 62:1122‐30. - PMC - PubMed
Rutgeerts 2015 {published data only}
    1. Rutgeerts P, Feagan BG, Marano CW, Padgett L, Strauss R, Johanns J, et al. Randomised clinical trial: a placebo‐controlled study of intravenous golimumab induction therapy for ulcerative colitis. Alimentary Pharmacology & Therapeutics 2015;42(5):504‐14. - PMC - PubMed
Sandborn 1994 {published data only}
    1. Sandborn WJ, Tremaine WJ, Schroeder KW, Batts KP, Lawson GM, Steiner BL, et al. A placebo‐controlled trial of cyclosporine enemas for mildly to moderately active left‐sided ulcerative colitis. Gastroenterology 1994; Vol. 106:1429‐35. - PubMed
Sandborn 2003 {published data only}
    1. Sandborn WJ, Sands BE, Wolf DC, Valentine JF, Safdi M, Katz S, et al. Repifermin (keratinocyte growth factor‐2) for the treatment of active ulcerative colitis: a randomized, double‐blind, placebo‐controlled, dose‐escalation trial. Alimentary Pharmacology & Therapeutics 2003;17:1355‐64. - PubMed
Sandborn 2012a {published data only}
    1. Ghosh S, Wolf D, Sandborn W, Colombel JF, Lazar A, Eichner S, et al. Sustained efficacy in patients with ulcerative colitis treated with adalimumab: results from ULTRA 2. Journal of Crohn's and Colitis 2013;7:S238.
    1. Mostafa NM, Eckert D, Pradhan RS, Mensing S, Robinson A, Sandborn W, et al. Exposure‐efficacy relationship (ER) for adalimumab during induction phase of treatment of adult patients with moderate to severe ulcerative colitis. Gastroenterology 2013;1:S225‐6.
    1. Sandborn W, Assche G, Reinisch W, Colombel JF, D'Haens G, Wolf D, et al. Induction and maintenance of clinical remission by adalimumab in patients with moderate‐to‐severe ulcerative colitis. Inflammatory Bowel Diseases 2011;17:S3‐4.
    1. Sandborn WJ, D'Haens GR, Colombel JF, Assche GA, Wolf DC, Kron M, et al. One‐year response and remission rates in ulcerative colitis patients with week 8 response to adalimumab: subanalysis of ULTRA 2. Gastroenterology 2012;1:S565.
    1. Sandborn WJ, Assche G, Reinisch W, Colombel JF, D'Haens G, Wolf D C, et al. Adalimumab induces and maintains clinical remission in patients with moderate‐to‐severe ulcerative colitis. Gastroenterology 2012;142:257‐65. - PubMed
Sandborn 2012b {published data only}
    1. Sandborn WJ, Travis S, Moro L, Jones R, Gautille T, Bagin R, et al. Once‐daily budesonide MMX extended‐release tablets induce remission in patients with mild to moderate ulcerative colitis: Results from the CORE i study. Gastroenterology 2012; Vol. 143:1218‐26. - PubMed
Sandborn 2012c {published data only}
    1. Sandborn WJ, Ghosh S, Panes J, Vranic I, Su C, Rousell S, et al. Tofacitinib, an oral janus kinase inhibitor, in active ulcerative colitis. New England Journal of Medicine 2012;367:616‐24. - PubMed
Sandborn 2012d {published data only}
    1. Sandborn WJ, Colombel JF, Sands BE, Rutgeerts P, Targan SR, Panaccione R, et al. Abatacept for Crohn's disease and ulcerative colitis. Gastroenterology 2012; Vol. 143:62‐9. - PubMed
Sandborn 2013a (BUCF3001) {published data only}
    1. Sandborn W, Bosworth B, Zakko S, Gordon G, Rolleri R, Yu J, et al. Budesonide foam for inducing remission in active mild‐to‐moderate ulcerative proctitis or ulcerative proctosigmoiditis: Results of two randomized, placebo‐controlled trials. American Journal of Gastroenterology 2013;108:S542.
Sandborn 2013b (BUCF3002) {published data only}
    1. Sandborn W, Bosworth B, Zakko S, Gordon G, Rolleri R, Yu J, et al. Efficacy and safety of budesonide foam for inducing remission in mildly to moderately active ulcerative proctitis or ulcerative proctosigmoiditis. Inflammatory Bowel Diseases 2013;19:S83.
Sandborn 2014a {published data only}
    1. Sandborn WJ, Feagan BG, Marano C, Zhang H, Strauss R, Johanns J, et al. Subcutaneous golimumab maintains clinical response in patients with moderate‐to‐severe ulcerative colitis. Gastroenterology 2014;146:96‐109. - PubMed
Sandborn 2014b {published data only}
    1. Sandborn WJ, Feagan BG, Marano C, Zhang H, Strauss R, Johanns J, et al. Subcutaneous golimumab induces clinical response and remission in patients with moderate‐to‐severe ulcerative colitis. Gastroenterology 2014;146:85‐95. - PubMed
Sandborn 2015 {published data only}
    1. Sandborn WJ, Colombel JF, Ghosh S, Sands BE, Dryden G, Hébuterne X, et al. Eldelumab [Anti‐IP‐10] induction therapy for ulcerative colitis: A randomised, placebo‐controlled, Phase 2b study. Journal of Crohn's and Colitis 2016;E‐pub ahead of print:1‐11. - PMC - PubMed
    1. Sandborn WJ, Colombel JF, Ghosh S, Sands BE, Xu LA, Luo A. Phase IIB, randomized, placebo‐controlled evaluation of the efficacy and safety of induction therapy with eldelumab (anti‐IP‐10 antibody; BMS‐936557) in patients with active ulcerative colitis. Gastroenterology 2014;146 (5 Suppl 1):S‐150.
Sands 2012 {published data only}
    1. Sands BE, Sandborn WJ, Creed TJ, Dayan CM, Dhanda AD, Assche GA, et al. Basiliximab does not increase efficacy of corticosteroids in patients with steroid‐refractory ulcerative colitis. Gastroenterology 2012; Vol. 143:356‐64.e1. - PubMed
Scherl 2009 {published data only}
    1. Bosworth BP, Pruitt RE, Gordon GL, Lamet M, Shaw AL, Huang S, et al. Balsalazide tablets 3.3 g twice daily improves signs and symptoms of mild‐to‐moderate ulcerative colitis. Gastroenterology 2008;134:A‐495.
    1. Scherl EJ, Pruitt R, Gordon GL, Lamet M, Shaw A, Huang S, et al. Safety and efficacy of a new 3.3 g b.i.d. tablet formulation in patients with mild‐to‐moderately‐active ulcerative colitis: a multicenter, randomized, double‐blind, placebo‐controlled study. American Journal of Gastroenterology 2009; Vol. 104:1452‐9. - PubMed
Schreiber 2007 {published data only}
    1. Schreiber S, Keshavarzian A, Isaacs KL, Schollenberger J, Guzman JP, Orlandi C, et al. A randomized, placebo‐controlled, phase II study of tetomilast in active ulcerative colitis. Gastroenterology 2007; Vol. 132:76‐86. - PubMed
Schroeder 1987 {published data only}
    1. Schroeder KW, Tremaine WJ, Ilstrup DM. Coated oral 5‐aminosalicylic acid therapy for mildly to moderately active ulcerative colitis. A randomized study. New England Journal of Medicine 1987; Vol. 317:1625‐9. - PubMed
Sninsky 1991 {published data only}
    1. Sninsky CA, Cort DH, Shanahan F, Powers BJ, Sessions JT, Pruitt RE, et al. Oral mesalamine (Asacol) for mildly to moderately active ulcerative colitis. A multicenter study. Annals of Internal Medicine 1991; Vol. 115:350‐5. - PubMed
Steinhart 1996 {published data only}
    1. Steinhart AH, Hiruki T, Brzezinski A, Baker JP. Treatment of left‐sided ulcerative colitis with butyrate enemas: a controlled trial. Alimentary Pharmacology and Therapeutics 1996; Vol. 10:729‐36. - PubMed
Sutherland 1987a {published data only}
    1. Sutherland LR, Martin F, Greer S. 5‐Aminosalicylic acid enema in the treatment of distal ulcerative colitis, proctosigmoiditis, and proctitis. Gastroenterology 1987;92:1894‐8. - PubMed
Sutherland 1987b {published data only}
    1. Sutherland LR, Martin F. 5‐Aminosalicylic acid enemas in treatment of distal ulcerative colitis and proctitis in Canada. Digestive Diseases and Sciences 1987; Vol. 32:64s‐6s. - PubMed
Sutherland 1990 {published data only}
    1. Sutherland LR, Robinson M, Onstad G, Peppercorn M, Greenberger N, Goodman M, et al. A double‐blind, placebo controlled, multicentre study of the efficacy and safety of 5‐aminosalicylic acid tablets in the treatment of ulcerative colitis. Canadian Journal of Gastroenterology 1990; Vol. 4:463‐7.
Suzuki 2014 {published data only}
    1. Suzuki Y, Motoya S, Hanai H, Matsumoto T, Hibi T, Robinson A, et al. Efficacy and safety of adalimumab in Japanese patients with moderately to severely active ulcerative colitis. Journal of Gastroenterology 2014;49(2):283‐94. - PMC - PubMed
Suzuki 2015 {published data only}
    1. Suzuki Y, Motoya S, Hirai F, Ogata H, Ito H, Sato N, et al. Infliximab therapy for Japanese patients with ulcerative colitis: Efficacy, safety, and association between serum infliximab levels and early response in a randomized, double‐blind, placebo‐controlled study. Journal of Crohn's and Colitis 2015;9:S372‐3.
Travis 2014 {published data only}
    1. Travis SPL, Danese S, Kupcinskas L, Alexeeva O, D'Haens G, Gibson PR, et al. Once‐daily budesonide MMX in active, mild‐to‐moderate ulcerative colitis: Results from the randomised CORE II study. Gut 2014;63:433‐41. - PMC - PubMed
Van Assche 2006 {published data only}
    1. Assche G, Sandborn WJ, Feagan BG, Salzberg BA, Silvers D, Monroe PS, et al. Daclizumab, a humanised monoclonal antibody to the interleukin 2 receptor (CD25), for the treatment of moderately to severely active ulcerative colitis: a randomised, double blind, placebo controlled, dose ranging trial. Gut 2006; Vol. 55:1568‐74. - PMC - PubMed
Vermeire 2011 {published data only}
    1. Vermeire S, Ghosh S, Panes J, Dahlerup JF, Luegering A, Sirotiakova J, et al. The mucosal addressin cell adhesion molecule antibody PF‐00547,659 in ulcerative colitis: A randomised study. Gut 2011;60:1068‐75. - PubMed
Vermeire 2014 {published data only}
    1. Vermeire S, O'Byrne S, Keir M, Williams M, Lu TT, Mansfield JC, et al. Etrolizumab as induction therapy for ulcerative colitis: A randomised, controlled, phase 2 trial. Lancet 2014;384(9940):309‐18. - PubMed
Watanabe 2013 {published data only}
    1. Watanabe M, Nishino H, Sameshima Y, Ota A, Nakamura S, Hibi T. Randomised clinical trial: Evaluation of the efficacy of mesalazine (mesalamine) suppositories in patients with ulcerative colitis and active rectal inflammation ‐ A placebo‐controlled study. Alimentary Pharmacology and Therapeutics 2013; Vol. 38:264‐73. - PubMed
Williams 1987 {published data only}
    1. Williams CN, Haber G, Aquino JA. Double‐blind, placebo‐controlled evaluation of 5‐ASA suppositories in active distal proctitis and measurement of extent of spread using 99mTc‐labeled 5‐ASA suppositories. Digestive Diseases and Science 1987; Vol. 32:71s‐5s. - PubMed
Yoshimura 2015 {published data only}
    1. Watanabe M, Yoshimura N, Motoya S, Tominaga K, Iwakiri R, Watanabe K, et al. AJM300, an oral A4 integrin antagonist, for active ulcerative colitis: A multicenter, randomized, double‐blind, placebo‐controlled phase 2a study. Gastrointestinal Endoscopy 2014;1:AB294.
    1. Watanabe M, Yoshimura N, Motoya S, Tominaga K, Iwakiri R, Watanabe K, et al. AJM300, an oral alpha4 integrin antagonist, for active ulcerative colitis: A multicenter, randomized, double‐blind, placebo‐controlled phase 2A study. Gastroenterology 2014;1:S‐82.
    1. Yoshimura N, Watanabe M, Motoya S, Tominaga K, Matsuoka K, Iwakiri R, et al. Safety and efficacy of AJM300, an oral antagonist of a4I integrin, in induction therapy for patients with active ulcerative colitis. Gastroenterology 2015;149:1775‐83. - PubMed

References to studies excluded from this review

Angus 1992 {published data only}
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Ardizzone 1999 {published data only}
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Armuzzi 2014 {published data only}
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Bayles 1995 {published data only}
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Biddle 1988 {published data only}
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Buckell 1978 {published data only}
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Burke 1990 {published data only}
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Campieri 1978 {published data only}
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Campieri 1981 {published data only}
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Campieri 1987 {published data only}
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Campieri 1988 {published data only}
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Campieri 1989 {published data only}
    1. Campieri M, Brunetti G, Miglioli M, Barbara L, Russo A, Aprile G, et al. Topical treatment with 5‐ASA suppositories in distal ulcerative colitis. A randomized double blind placebo controlled study with Asacol suppositories. An Italian co‐operative study group. Italian Journal of Gastroenterology 1989; Vol. 21:15‐6.
Campieri 1990a {published data only}
    1. Campieri M, Gionchetti P, Belluzzi A, Brignola C, Tampieri M, Iannone P, et al. Topical treatment with 5‐aminosalicylic in distal ulcerative colitis by using a new suppository preparation. A double‐blind placebo controlled trial. International Journal of Colorectal Disease 1990; Vol. 5, issue 2:79‐81. - PubMed
Campieri 1990b {published data only}
    1. Campieri M, Franchis R, Bianchi Porro G, Ranzi T, Brunetti G, Barbara L. Mesalazine (5‐aminosalicylic acid) suppositories in the treatment of ulcerative proctitis or distal proctosigmoiditis. A randomized controlled trial. Scandanavian Journal of Gastroenterology 1990; Vol. 25, issue 7:663‐8. - PubMed
Campieri 1991a {published data only}
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Campieri 1991b {published data only}
    1. Campieri M, Bianchi P, Bianchi P G, d'Albasio G, Capurso L, Cottone M, et al. Comparison of 5‐ASA (ASACOL®) enema and foam in the treatment of distal ulcerative colitis. Italian Journal of Gastroenterology 1991; Vol. 23:510‐1.
D'Albasio 1995 {published data only}
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D'Albasio 1997 {published data only}
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D'Albasio 1998 {published data only}
    1. d'Albasio G, Paoluzi P, Campieri M, Bianchi Porro G, Pera A, Prantera C, et al. Maintenance treatment of ulcerative proctitis with mesalazine suppositories: a double‐blind placebo‐controlled trial. The Italian IBD Study Group. American Journal of Gastroenterology 1998;93(5):799‐803. - PubMed
D'Arienzo 1990 {published data only}
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D'Haens 2010 {published data only}
    1. D'Haens G R, Kovacs A, Vergauwe P, Nagy F, Molnar T, Bouhnik Y, et al. Clinical trial: Preliminary efficacy and safety study of a new Budesonide‐MMX 9 mg extended‐release tablets in patients with active left‐sided ulcerative colitis. Journal of Crohn's & colitis 2010;4:153‐60. - PubMed
Danielsson 1992 {published data only}
    1. Danielsson A, Lofberg R, Persson T, Salde L, Schioler R, Suhr C, et al. A steroid enema, budesonide, lacking systemic effects for the treatment of distal ulcerative colitis or proctitis. Scandinavian Journal of Gastroenterology 1992;27(1):9‐12. - PubMed
Da Silva Sanchez 2014 {published data only}
    1. Silva Sanchez S, Palmen M, Streck P, Inglis S. Pooled clinical trial analysis of MMX mesalazine safety: Focus on 4.8 g/d long‐term exposure. Journal of Crohn's and Colitis 2014;8(Supp 1):S230.
Davies 1977 {published data only}
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Dew 1982 {published data only}
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Dick 1964 {published data only}
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Dickinson 1985 {published data only}
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Dissanayake 1973 {published data only}
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Feagan 2012 {published data only}
    1. Feagan B, Sandborn W, Lazar A, Thakkar R, Skup M, Yang M, et al. Adalimumab induction dose reduces the risk of hospitalizations and colectomies in patients with ulcerative colitis during the first 8 weeks of therapy. American Journal of Gastroenterology 2012;107:S647.
Feurle 1989 {published data only}
    1. Feurle GE, Theuer D, Velasco S, Barry BA, Wördehoff D, Sommer A, et al. Olsalazine versus placebo in the treatment of mild to moderate ulcerative colitis: a randomised double blind trial. Gut 1989; Vol. 30, issue 10:1354‐61. - PMC - PubMed
Fruehmorgen 1980 {published data only}
    1. Fruehmorgen P, Demling L. On the efficacy of ready‐made‐up commercially available salicylazosulphapyridine enemas in the treatment of proctitis, proctosigmoiditis and ulcerative colitis involving rectum, sigmoid and descending colon. Hepato‐Gastroenterology 1980;27(6):473‐6. - PubMed
Fruhmorgen 1981 {published data only}
    1. Fruhmorgen P. The effectiveness of packaged salicylazosulfapyridine (Azulfidine)‐enema in proctitis, proto‐sigmoiditis and left‐sided colitis [German]. Zeitschrift fur Gastroenterologie 1981;19:36‐7. - PubMed
Gandolfo 1987 {published data only}
    1. Gandolfo J, Farthing M, Powers G. 4‐Aminosalicyclic acid retention enemas in treatment of distal colitis. Digestive Diseases and Sciences 1987;32(7):700‐4. - PubMed
Ginsberg 1985 {published data only}
    1. Ginsberg AL, Steinberg WM, Nochomovitz LE. Deterioration of Left Sided Ulcerative Colitis After Withdrawl of Sulfasalazine. Gastroenterology 1985;88(5 Part 2):A1395.
Ginsberg 1988 {published data only}
    1. Ginsberg AL, Beck LS, McIntosh TM, Nochomovitz LE. Treatment of left‐sided ulcerative colitis with 4‐aminosalicylic acid enemas. A double‐blind, placebo‐controlled trial. Annals of Internal Medicine 1988; Vol. 108:195‐9. - PubMed
Ginsberg 1992 {published data only}
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Gionchetti 1999 {published data only}
    1. Gionchetti P, Rizzello F, Ferrieri A, Venturi A, Brignola C, Ferretti M, et al. Rifaximin in patients with moderate or severe ulcerative colitis refractory to steroid‐treatment: a double‐blind, placebo‐controlled trial. Digestive Diseases and Sciences 1999; Vol. 44:1220‐1. - PubMed
Hanauer 1989 {published data only}
    1. Hanauer SB, Kane SV, Guernsey B. Randomized Clinical Trial of Mesalamine (5‐ASA) Enemas in Distal Ulcerative Colitis: A Dose‐Ranging Placebo Controlled Study. Gastroenterology 1989;96(5 Part 2):A195.
Hanauer 1989a {published data only}
    1. Hanauer SB, Schwartz J, Roufail W. Dose‐Ranging Study of Oral Mesalamine Capsule (Pentasa) for Active Ulcerative Colitis. Gastroenterology 1989;96(5 Part 2):A195.
Hanauer 1990 {published data only}
    1. Hanauer S, Beshears L, Wilkinson C. Induction of Remission in a Dose‐Ranging Study of Oral Mesalamine Capsules (Pentasa). Gastroenterology 1990; Vol. 98, issue 5 Part 2:A174.
Hanauer 1992 {published data only}
    1. Hanauer S B, Lingamneni S, McPherson M, Beshears L. Placebo response in UC: analysis of a multi‐center, double‐blind trial of controlled‐ release mesalamine (Pentasa). Gastroenterology 1992;102:A634.
Hanauer 1993 {published data only}
    1. Hanauer S, Schwartz J, Robinson M, Roufail W, Arora S, Cello J, et al. Mesalamine capsules for treatment of active ulcerative colitis: results of a controlled trial. Pentasa Study Group. American Journal of Gastroenterology 1993;88:1188‐97. - PubMed
Hanauer 1994 {published data only}
    1. Hanauer S, Powers B, Robinson M, Mayle J, Elson C, DeMicco M, et al. Maintenance of remission of ulcerative colitis by mesalamine (Asacol) vs. placebo. Gastroenterology 1994;106:A696.
Hanauer 1996a {published data only}
    1. Hanauer SB. An oral preparation of mesalamine as long‐term maintenance therapy for ulcerative colitis. A randomized, placebo‐controlled trial. Annals of Internal Medicine 1996;124:204‐11. - PubMed
Hanauer 1996b {published data only}
    1. Hanauer SB, Barish C, Pambianco D, Sigmon R, Gannan R, Koval G, et al. A multi‐center, double‐blind, placebo‐controlled, dose‐ranging trial of olsalazine for mild‐moderately active ulcerative colitis. Gastroenterology 1996;110:A921.
Hanauer 1998 {published data only}
    1. Hanauer SB. Dose‐ranging study of mesalamine (PENTASA) enemas in the treatment of acute ulcerative proctosigmoiditis: results of a multicentered placebo‐controlled trial. The U.S. PENTASA Enema Study Group. Inflammatory Bowel Diseases 1998; Vol. 4:79‐83. - PubMed
Hanauer 1998a {published data only}
    1. Hanauer SB, Robinson M, Pruitt R, Lazenby AJ, Persson T, Nilsson LG, et al. Budesonide enema for the treatment of active, distal ulcerative colitis and proctitis: A dose‐ranging study. Gastroenterology 1998;115:525‐32. - PubMed
Hanauer 2007 {published data only}
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Hanauer 2009 {published data only}
    1. Hanauer SB, Lichtenstein GR, Kamm MA, Sandborn WJ, Lees KH, Barrett K, et al. MMX mesalamine for induction and maintenance therapy in mild‐to‐moderate ulcerative colitis. Gastroenterology and Hepatology 2009;5:494‐500. - PMC - PubMed
Hawkey 1994 {published data only}
    1. Hawkey C, Gassull M, Lauritsen K, Martin F, O'Morain C, Rask‐Madsen J, et al. Efficacy of zileuton, a 5‐lipoxygenase inhibitor, in the maintenance of remission in patients with ulcerative colitis. Gastroenterology 1994;106:A697.
Hawkey 1997 {published data only}
    1. Hawkey C J, Dube L M, Rountree L V, Linnen P J, Lancaster J F. A trial of zileuton versus mesalazine or placebo in the maintenance of remission of ulcerative colitis. Gastroenterology 1997;112:718‐24. - PubMed
Hawthorne 1992 {published data only}
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Hetzel 1985 {published data only}
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    1. Kamm M A, Lichtenstein G R, Sandborn W J, Schreiber S, Lees K, Barrett K, et al. Effect of extended MMX mesalamine therapy for acute, mild‐to‐moderate ulcerative colitis. Inflammatory Bowel Diseases 2009;15:1‐8. - PubMed
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Zinberg 1990 {published data only}
    1. Zinberg J, Molinas S, Das KM. Double‐blind placebo‐controlled study of olsalazine in the treatment of ulcerative colitis. American Journal of Gastroenterology 1990; Vol. 85, issue 5:562‐6. - PubMed

References to studies awaiting assessment

Atreya 2016a {published data only}
    1. Atreya R, Bloom S, Scaldaferri F, Gerardi V, Admyre C, Karlsson A, et al. Clinical effects of a topically applied toll‐like receptor 9 agonist in active moderate‐to‐severe ulcerative colitis. Journal of Crohn's and Colitis 2016;10(11):1294‐1302. - PMC - PubMed
Harris 2016a {published data only}
    1. Harris MS, Hartman D, Lemos BR, Erlich EC, Spence S, Kennedy S, Ptak T, et al. AVX‐470, an orally delivered anti‐tumour necrosis factor antibody for treatment of active ulcerative colitis: results of a first‐in‐human trial. Journal of Crohn's and Colitis 2016;10(6):631‐40. - PubMed
Kucharzik 2017 {published data only}
    1. Kucharzik T, Lemmnitz G, Abels C, Maaser C. Tripeptide K(D)PT Is well tolerated in mild‐to‐moderate ulcerative colitis: results from a randomized multicenter study. Inflammatory Bowel Diseases 2017;23(2):261‐71. - PubMed
Naganuma 2016a {published data only}
    1. Naganuma M, Aoyama N, Suzuki Y, Nishino H, Kobayashi K, Hirai F, et al. Twice‐daily budesonide 2‐mg foam induces complete mucosal healing in patients with distal ulcerative colitis. Journal of Crohn's and Colitis 2016;10(7):828‐36. - PMC - PubMed
Sandborn 2016a {published data only}
    1. Sandborn WJ, Colombel JF, Ghosh S, Sands BE, Dryden G, Hébuterne X, et al. Eldelumab [Anti‐IP‐10] induction therapy for ulcerative colitis: a randomised, placebo‐controlled, phase 2b study. Journal of Crohn's and Colitis 2016;10(4):418‐28. - PMC - PubMed
Sandborn 2016b {published data only}
    1. Sandborn WJ, Feagan BG, Wolf DC, D'Haens G, Vermeire S, Hanauer SB, et al. Ozanimod induction and maintenance treatment for ulcerative colitis. New England Journal of Medicine 2016;374(18):1754‐62. - PubMed
Sandborn 2016c {published data only}
    1. Sandborn W, Sands BE, D'Haens GR, Vermeire S, Schreiber S, Danese S, et al. Efficacy and safety of oral tofacitinib as induction therapy in patients with moderate to severe ulcerative colitis: results from two phase 3 randomized controlled trials. Gastroenterology 2016;4(Supp 1):S157.
Sandborn 2016d {published data only}
    1. Sandborn WJ, Bhandari BR, Fogel R, Onken J, Yen E, Zhao X, et al. Randomised clinical trial: a phase 1, dose‐ranging study of the anti‐matrix metalloproteinase‐9 monoclonal antibody GS‐5745 versus placebo for ulcerative colitis. Alimentary Pharmacology and Therapeutics 2016;44(2):157‐69. - PMC - PubMed
Van Assche 2016 {published data only}
    1. Assche G, Rutgeerts P, Ferrante M, Noman M, Fidder H, Oldenburg B, et al. Safety and efficacy of a novel IV targeted pegylated liposomal prednisolone product (Nanocort): results from a phase 2a study in patients with active ulcerative colitis. Journal of Crohn's and Colitis 2016;10(Supp 1):S39‐40.

Additional references

Dieppe 2013
    1. Dieppe P. Trial designs and exploration of the placebo response. Complementary Therapies in Medicine 2013;21:105‐8. - PubMed
Duval 2000
    1. Duval S, Tweedie R. Trim and fill: A simple funnel‐plot‐based method of testing and adjusting for publication bias in meta‐analysis. Biometrics 2000;56(2):455‐63. - PubMed
Egger 1997a
    1. Egger M, Davey Smith G, Schneider M, Minder C. Bias in meta‐analysis detected by a simple, graphical test. BMJ 1997;315(7109):629‐34. - PMC - PubMed
Enck 2013
    1. Enck P, Bingel U, Schedlowski M, Rief W. The placebo response in medicine: minimize, maximize or personalize?. Nature Reviews Drug Discovery 2013;12(3):191‐204. - PubMed
Higgins 2002
    1. Higgins JP, Thompson SG. Quantifying heterogeneity in a meta‐analysis. Statistics in Medicine 2002;21(11):1539‐58. - PubMed
Higgins 2011a
    1. Higgins JPT, Deeks JJ (editors). Chapter 7: Selecting studies and collecting data. In: Higgins JPT, Green S editor(s). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 (updated March 2011). The Cochrane Collaboration, 2011. Available from www.cochrane‐handbook.org.
Higgins 2011b
    1. Higgins JPT, Altman DG, Sterne JAC (editors). Chapter 8: Assessing risk of bias in included studies. In: Higgins JPT, Green S editor(s). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 (updated March 2011). The Cochrane Collaboration, 2011. Available from www.cochrane‐handbook.org.
Jairath 2016
    1. Jairath V, Zou G, Parker CE, MacDonald JK, Mosli MH, Khanna R, et al. Systematic review and meta‐analysis: placebo rates in induction and maintenance trials of ulcerative colitis. Journal of Crohn's and Colitis 2016;10(5):607‐18. - PMC - PubMed
Rief 2009
    1. Rief W, Nestoriuc Y, Weiss S, Welzel E, Barsky AJ, Hofmann SG. Meta‐analysis of the placebo response in antidepressant trials. Journal of Affective Disorders 2009;118:1‐8. - PubMed
Schmid 2004
    1. Schmid CH, Cappelleri JC, Lau J. Bayesian methods to improve sample size approximations. Methods in Enzymology 2004;383:406‐27. - PubMed
Stijnen 2010
    1. Stijnen T, Hamza TH, Ozdemir P. Random effects meta‐analysis of event outcome in the framework of the generalized linear mixed model with applications in sparse data. Statistics in Medicine 2010;29(29):3046‐67. - PubMed
Su 2007
    1. Su C, Lewis JD, Goldberg B, Brensinger C, Lichtenstein GR. A meta‐analysis of the placebo rates of remission and response in clinical trials of active ulcerative colitis. Gastroenterology 2007;132(2):516‐26. - PubMed
Thompson 2002
    1. Thompson SG, Higgins JP. How should meta‐regression analyses be undertaken and interpreted?. Statistics in Medicine 2002;21(11):1559‐73. - PubMed

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