Risk–benefit analysis of adalimumab versus traditional non-biologic therapies for patients with Crohnʼs disease

Loftus, Edward V.; Johnson, Scott J.; Wang, Si Tien; Wu, Eric Q.; Mulani, Parvez; Chao, Jingdong

doi:10.1002/ibd.21341

Cited by 9 publications

(3 citation statements)

References 59 publications

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“…Of these 139 papers were isolated for full‐text review based on titles and abstracts. Twenty‐one of these were excluded (κ = 0.920, 95% CI 0.832–1.000). The 118 included papers covering 193 256 patients were allocated to one of three categories depending on their speciality focus: M (80 papers, 135 375 patients), S (28 papers, 36 521 patients) or MS (10 papers, 24 823 patients).…”

Section: Resultsmentioning

confidence: 99%

Inflammatory bowel disease meta‐evidence and its challenges: is it time to restructure surgical research?

et al. 2015

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Section: Resultsmentioning

confidence: 99%

Inflammatory bowel disease meta‐evidence and its challenges: is it time to restructure surgical research?

et al. 2015

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“…These specificities have however made them unsuitable for subsequent application in a general benefit–risk framework. An overview of these methods , including advantages and limitations, is provided in Supplementary Table S. By contrast, multi‐criteria decision analysis (MCDA) in combination with decision trees has been suggested as a plausible quantitative approach that embeds the needed features for a generalized and structured framework for benefit–risk evaluation.…”

Section: Current Approachesmentioning

confidence: 99%

Integration of PKPD relationships into benefit–risk analysis

Bellanti

Wijk

Danhof

et al. 2015

Brit J Clinical Pharma

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Aim Despite the continuous endeavour to achieve high standards in medical care through effectiveness measures, a quantitative framework for the assessment of the benefit–risk balance of new medicines is lacking prior to regulatory approval. The aim of this short review is to summarise the approaches currently available for benefit–risk assessment. In addition, we propose the use of pharmacokinetic–pharmacodynamic (PKPD) modelling as the pharmacological basis for evidence synthesis and evaluation of novel therapeutic agents. Methods A comprehensive literature search has been performed using MESH terms in PubMed, in which articles describing benefit–risk assessment and modelling and simulation were identified. In parallel, a critical review of multi‐criteria decision analysis (MCDA) is presented as a tool for characterising a drug's safety and efficacy profile. Results A definition of benefits and risks has been proposed by the European Medicines Agency (EMA), in which qualitative and quantitative elements are included. However, in spite of the value of MCDA as a quantitative method, decisions about benefit–risk balance continue to rely on subjective expert opinion. By contrast, a model‐informed approach offers the opportunity for a more comprehensive evaluation of benefit–risk balance before extensive evidence is generated in clinical practice. Conclusions Benefit–risk balance should be an integral part of the risk management plan and as such considered before marketing authorisation. Modelling and simulation can be incorporated into MCDA to support the evidence synthesis as well evidence generation taking into account the underlying correlations between favourable and unfavourable effects. In addition, it represents a valuable tool for the optimization of protocol design in effectiveness trials.

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“…In der Placebogruppe traten sogar mehr schwerwiegende unerwünschte Nebenwirkungen auf als unter Adalimumab (Adalimumab 40 mg 2-wöchentlich: 9,2 %; unter Adalimumab 40 mg wöchentlich: 8,2 % Placebo: 15 zu weniger bzw. einer ähnlichen Anzahl schwerer unerwünschter Nebenwirkungen, unerwünschter Nebenwirkungen und schwerer Infektionen kam als unter einer Standardtherapie (p < 0,01) [34]. Eine prospektive Auswertung der CHOICE-Studie zeigte, dass Adalimumab auch bei einem schwer behandelbaren Patientenkollektiv (primäres oder sekundäres Therapieversagen bzw.…”

Section: Sicherheit In Der Therapiedurchführungunclassified

Adalimumab in der Behandlung des adulten Morbus Crohn - Update eines Konsensus der Arbeitsgruppe Chronisch Entzündliche Darmerkrankungen der Österreichischen Gesellschaft für Gastroenterologie und Hepatologie

et al. 2013

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TNF alpha antibodies have clearly improved the outcome of moderate to severe Crohn's disease. Adalimumab is the first fully human, monoclonal TNF alpha antibody, which can be self-administered subcutaneously. Since August 2012 adalimumab is approved for the treatment of moderately to severely active Crohn's disease, in patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant or who are intolerant to or have medical contraindications for such therapies. Compared to placebo adalimumab can induce significantly more often steroid-free remission and mucosal healing in patients with moderate to severe Crohn's disease, reduce the rate of Crohn's disease-related hospitalisations and surgery and improve health-related quality of life. Adalimumab is clinically efficacious both in patients with Crohn's disease naïve to previous exposure to TNF-alpha antibodies and in those previously exposed with a rapid onset of action within days and confirmed maintenance performance over 3 years. The safety profile of adalimumab is comparable to those of other TNF alpha inhibitors. Due to its low immunogenicity allergic reactions are rare. The update of a consensus report by the Working Group Inflammatory Bowel Disease of the Austrian Society of Gastroenterology and Hepatology presents the existing evidence on adalimumab for the treatment of Crohn's disease and is aimed to assist as a code of practice in its applications.

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Risk–benefit analysis of adalimumab versus traditional non-biologic therapies for patients with Crohnʼs disease

Abstract: Adalimumab demonstrated greater benefits and lower rates of AEs versus traditional non-biologic therapies for patients with moderately to severely active CD who were refractory to non-biologic therapies.

Cited by 9 publications

References 59 publications

Inflammatory bowel disease meta‐evidence and its challenges: is it time to restructure surgical research?

Inflammatory bowel disease meta‐evidence and its challenges: is it time to restructure surgical research?

Integration of PKPD relationships into benefit–risk analysis

Adalimumab in der Behandlung des adulten Morbus Crohn - Update eines Konsensus der Arbeitsgruppe Chronisch Entzündliche Darmerkrankungen der Österreichischen Gesellschaft für Gastroenterologie und Hepatologie

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