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Treats Crohn disease and multiple sclerosis (MS).

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A meta-analysis on the efficacy and tolerability of natalizumab in relapsing multiple sclerosis

The review concluded that available data on the efficacy and safety of natalizumab were insufficient to reach a convincing conclusion. The review had some methodological problems, but the authors? conclusions are suitably cautious and appear appropriate.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2010

Interferons and natalizumab for multiple sclerosis

Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system which is accompanied by considerable disability and high costs. This report summarises the evidence on effectiveness and costs of beta-interferons and natalizumab in the treatment of multiple sclerosis.The review included systematic reviews and randomised controlled trials (with an observation time of at least one year) in patients with MS which assessed outcome parameters such as progression, exacerbations and adverse effects. An extensive literature search included databases such as MEDLINE, EMBASE, the Cochrane Library and various HTA-databases. Studies were selected according to predefined criteria, their quality was assessed according to criteria defined prospectively, and data were summarised systematically in tables. Cost-effectiveness evaluations were also included.Two systematic reviews and 24 randomised controlled trials of beta-interferon therapy were included, as well as three trials on the effectiveness of natalizumab. A total of 22 cost-effectiveness analyses for interferons were included, whereas no economic evaluations for natalizumab were identified.Use of interferon beta-1a or interferon beta-1b after a first demyelinating event led to a reduction of the conversion to definite MS during an observation time of two to three years. In relapsing remitting MS, interferon beta-1a reduced progression. The effects of interferon beta-1b on progression are unclear. Interferon beta-1a and interferon beta-1b reduced in some but not all studies outcomes relating to exacerbations. In direct comparison trials, interferon beta-1b (Betaferon(®) or Betaseron(®)) and interferon beta-1a (Rebif(®), higher dosage of 44 µg three subcutaneous injections per week) proved superior to interferon beta-1a (Avonex(®), 30 µg per week intramuscular) with respect to exacerbation outcomes. For secondary progressive MS, only one of five studies found a reduced progression with interferon beta-1a and only a part of the studies found an improvement with respect to outcomes relating to exacerbations. For primary progressive MS no advantage of therapy with beta-interferons was found with respect to patient-related outcomes. Beta-interferons showed characteristic and frequently occurring adverse effects, including reactions at the injection site and flu-like symptoms. A large proportion of patients stop interferon therapy because of adverse events. The other main reason for stopping therapy is the felt ineffectiveness of the treatment when patients experience a new exacerbation while on treatment. Many patients produce interferon-neutralising antibodies during therapy. The ultimate effect of neutralising antibodies on the efficacy of interferon treatment is unclear.In patients with relapsing remitting (and partially with secondary progressive) MS, treatment with natalizumab led to a reduction of progression and of exacerbation rates. However, a number of cases of progressive multifocal leucoencephalopathy have been reported after natalizumab therapy. These raise serious concerns about patient safety. Reliable data on the long term effectiveness of beta-interferons or natalizumab are not yet available.The absolute cost of interferon therapy is high and the available, international cost-effectiveness analyses indicate a high cost for achieving moderate benefits in quality of life. Further research is needed to provide specific cost-effectiveness estimates for Germany.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2008

Efficacy and safety of natalizumab for multiple sclerosis and Crohn's disease: a meta analysis

OBJECTIVE: To systematically evaluate the safety and efficacy of natalizumab in treating multiple sclerosis (MS) and Crohn's disease(CD).

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2010

The use of the monoclonal antibody Natalizumab (NTZ) in patients with relapsing remitting multiple sclerosis (RRMS)

It is currently thought that inflammation is crucial in MS, leading to a disruption in the ability of nerves to conduct impulses. NTZ is the first of a new generation of anti‐inflammatory treatments for MS, which is given intravenously every 4 weeks. It is usually prescribed once other drugs have failed or when the disease is rapidly worsening.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2011

Natalizumab for treatment of active Crohn's disease

Crohn's disease is a chronic inflammatory disease of the intestines. Crohn's disease frequently occurs in the lower part of the small intestine, called the ileum, but it can affect any part of the digestive tract, from the mouth to the anus. The most common symptoms of Crohn's disease are abdominal pain, often in the lower right area, and diarrhea. Natalizumab blocks the adhesion and migration of white blood cells into the gut reducing chronic inflammation associated with Crohn's disease. Four high quality studies were reviewed. The studies tested 1692 people over the age of eighteen who had moderate to severe Crohn's disease. The subjects received 1 to 3 infusions of natalizumab (at a dosage of 300 mg or weight based dosages of 3, 4 or 6 mg/kg) or placebo (fake infusions). The studies lasted for 12 weeks. The results of the studies indicate that natalizumab is effective therapy for some people with active Crohn's disease. People with active disease responded positively to even one treatment of the drug and the studies examined showed increased benefits with additional injections of natalizumab. More people improved through treatment using natalizumab than those using the fake treatments. The drug was generally well tolerated and side effects occurred infrequently. Serious side effects occurred rarely (range 7 to 11% for natalizumab and placebo patients). Few patients withdrew from the studies due to side effects (2 to 8% for natalizumab compared to 3 to 7% for placebo). Side effects that occurred during the trials included: headache, worsening of Crohn's disease, abdominal pain, arthralgia, colitis, influenza syndrome, infection, nausea, vomiting, fatigue, hypersensitivity‐like reactions, and the development of antibodies against natalizumab. Recently, it was found that two patients who received natalizumab in combination with interferon beta‐1 for multiple sclerosis and one patient who received natalizumab in combination with azathioprine for Crohn's disease developed a severe disease called progressive multifocal leukoencephalopathy (PML) resulting in two deaths. PML is a serious infection of the nervous system. However an investigation of more than 3500 patients who took natalizumab found no new cases of PML. It was discovered that PML is not always fatal and regular testing of patients could provide adequate safety and ensure the well‐being of those taking natalizumab. However, the benefits of natalizumab for people with Crohn's disease should be carefully weighed against the potential risk of serious adverse events such as the possibility of infection of the nervous system.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2009

Comparing Drugs for Multiple Sclerosis

How do disease-modifying drugs compare in multiple sclerosis?

PubMed Clinical Q&A [Internet] - National Center for Biotechnology Information (US).

Version: February 11, 2011

Drug Class Review: Disease-modifying Drugs for Multiple Sclerosis: Final Update 1 Report [Internet]

We compared the effectiveness and safety of disease-modifying drugs for the treatment of multiple sclerosis: Glatiramer acetate (Copaxone®), interferon beta-1a (Avonex®, Rebif®), interferon beta-1b (Betaseron®, Extavia®), mitoxantrone (Novantrone®), and natalizumab (Tysabri®).

Drug Class Reviews - Oregon Health & Science University.

Version: August 2010
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Comparing Fingolimod with other MS Drugs

How does fingolimod compare in multiple sclerosis?

PubMed Clinical Q&A [Internet] - National Center for Biotechnology Information (US).

Version: November 30, 2011

Comparing Targeted Immune Modulators

Targeted immune modulators (also referred to as biologics) form a relatively new class of drugs for diseases with chronic inflammation and an inappropriate immune response. Such diseases include rheumatoid arthritis, psoriasis, and inflammatory bowel diseases.

PubMed Clinical Q&A [Internet] - National Center for Biotechnology Information (US).

Version: November 21, 2012

Drug Class Review: Targeted Immune Modulators: Final Update 3 Report [Internet]

We systematically compared the efficacy, effectiveness, and safety (adverse events) of abatacept, adalimumab, alefacept, anakinra, certolizumab pegol, etanercept, golimumab, infliximab, natalizumab, rituximab, tocilizumab, and ustekinumab in patients with rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis, Crohn’s disease, ulcerative colitis, and plaque psoriasis.

Drug Class Reviews - Oregon Health & Science University.

Version: March 2012
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A Systematic Review and Economic Evaluation of the Use of Tumour Necrosis Factor-Alpha (TNF-α) Inhibitors, Adalimumab and Infliximab, for Crohn's Disease

Crohn's disease (CD) is a severe, lifelong disease characterised by inflammation of the gastrointestinal mucosa. The impact on patients and society is high as ill health can be lifelong and can negatively affect patients' quality of life. Costs to the NHS are high, particularly for patients needing hospitalisation. Conventional treatment pathways are complex. More recently, a group of drugs called tumour necrosis factor (TNF) inhibitors (anti-TNF-α agents) have been evaluated for their effectiveness in CD. One of these, infliximab, is currently recommended by the National Institute for Health and Clinical Excellence (NICE; 2002) for patients with severe, active CD where patients are refractory to or intolerant of conventional treatment.

Health Technology Assessment - NIHR Evaluation, Trials and Studies Coordinating Centre (UK).

Version: February 2011
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Management of Relapsing-Remitting Multiple Sclerosis [Internet]

Multiple sclerosis (MS) is a chronic inflammatory disorder of the central nervous system that is more common in women than in men, by a factor of approximately 3:1. Canada has the fifth-highest worldwide prevalence at 240 per 100,000 persons.

CADTH Therapeutic Review - Canadian Agency for Drugs and Technologies in Health.

Version: October 2013
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Disease-modifying drugs for multiple sclerosis in pregnancy: a systematic review

OBJECTIVE: To systematically review the literature regarding safety of disease-modifying drug (DMD) use during pregnancy on perinatal and developmental outcomes in offspring of patients with multiple sclerosis (MS).

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2012

Comparative efficacy and risk‐benefit balance of modulator and suppressant drugs of the immune system in people with multiple sclerosis (MS)

Several immunotherapies have been used to treat MS, but their relative effectiveness is unclear due to the limited number of direct comparison studies. The authors of this review tried to assess the efficacy and the extent of adverse events of immunotherapies commonly used in people with MS. Eleven agents were studied, interferon ß‐1b (IFNß‐1b) (Betaseron), IFNß‐1a (Rebif and Avonex), glatiramer acetate, natalizumab, mitoxantrone, methotrexate, cyclophosphamide, azathioprine, immunoglobulins, and long‐term corticosteroids.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2013

Efficacy of biological therapies in inflammatory bowel disease: systematic review and meta-analysis

OBJECTIVES: Crohn's disease (CD) and ulcerative colitis (UC) are inflammatory disorders of the gastrointestinal tract of unknown etiology. Evidence for treatment of the condition with biological therapies exists, but no systematic review and meta-analysis has examined this issue in its entirety.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2011

Network analysis of randomized controlled trials in multiple sclerosis

This review found that natalizumab (300mg) and fingolimod (0.5mg) were better than placebo, and alemtuzumab may be better than interferon beta-1b (250?g) in the treatment of multiple sclerosis. The review was well conducted and the results may be reliable, but the reliance on indirect comparisons of treatments means that the results should be interpreted with some caution.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2012

Pharmacologic Therapies for the Management of Crohn's Disease: Comparative Effectiveness [Internet]

The purpose of this review was to compare the efficacy and safety of biologics, immunomodulators, corticosteroids, and aminosalicylates in the treatment of Crohn's disease.

Comparative Effectiveness Reviews - Agency for Healthcare Research and Quality (US).

Version: February 2014
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Teriflunomide, a new oral therapy for multiple sclerosis (MS)

New disease‐modifying therapies (DMTs) with less invasive routes of administration and new modes of action are in development to expand the available DMT options and enhance adherence, thereby improving efficacy. Teriflunomide is an oral disease‐modifying drug with immunosuppressive and immunomodulatory properties.The authors of this review assessed the efficacy and safety of teriflunomide in patients with different forms of MS (relapsing‐remitting (RRMS), secondary progressive (SPMS) with relapse, and progressive relapsing MS (PRMS)). They took into account the annualised rate of relapse, the proportion of patients free of disability progression, and the number of brain lesions. Among the pertinent literature, two studies met the inclusion criteria. They involved a total of 1204 patients and evaluated the efficacy and safety of teriflunomide alone or with add‐on IFN‐β, respectively, versus placebo. The authors were unable to give any clear recommendations for the use of teriflunomide as a DMT for MS because the studies had limited quality, were of short duration and were funded by a pharmaceutical company. As far as safety is concerned, common adverse events included headache, diarrhoea, fatigue, elevated alanine aminotransferase levels, nausea, hair thinning or decreased hair density, influenza, and urinary tract infection. Future studies are needed with higher methodological quality, a better evaluation of the adverse events, and a longer period of teriflunomide administration.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2012

Laquinimod, a new oral disease‐modifying drug for multiple sclerosis (MS)

Disease‐modifying therapies (DMTs) for MS currently aim to specifically reduce inflammation in relapsing MS and promote protection and repair of the nervous system in progressive MS. Laquinimod is a new oral disease‐modifying drug (DMD) with dual properties of modulation of the immune system and protection of the nervous system. The authors of this review assessed the efficacy and safety of laquinimod in patients with MS. Concerning the outcomes, they considered relapse, disability progression, inflammatory lesion, and brain atrophy. Among the pertinent literature only one study met the inclusion criteria. The study involved a total of 1106 patients with relapsing‐remitting MS and evaluated the efficacy and safety of laquinimod as unique therapy versus placebo. As far as safety was concerned, common adverse events included headache, back pain, arthralgia, diarrhoea, cough, urinary tract infection, elevated alanine aminotransferase, insomnia, nausea, abdominal pain and sinusitis. The authors were unable to give any clear recommendations for the use of laquinimod as a DMD for MS because the study was poor quality and was funded by a pharmaceutical company. Future studies with higher methodological quality are needed to assess the potential benefits and the safety in a longer period of administration.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2013

The use of the monoclonal antibody rituximab in patients with relapsing remitting multiple sclerosis (RRMS)

This is an update of the Cochrane review "Rituximab for relapsing‐remitting multiple sclerosis" (first published in The Cochrane Library 2011, Issue 12).

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2014

Systematic Reviews in PubMed

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