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Author Thaler, K.J.; Gartlehner, G.; Kien, C.; Van Noord, M.G.; Thakurta, S.; Wines, R.C.M.; Hansen, R.A.; McDonagh, M.S. url  openurl
  Title (up) Type Book
  Year 2012 Publication Abbreviated Journal  
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  Abstract 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. To identify published studies, we searched PubMed, EMBASE, CINAHL, Centre for Reviews and Dissemination, The Cochrane Library, and International Pharmaceutical Abstracts from 2009 (January) to 2011 (October). We also searched the US Food and Drug Administration Center for Drug Evaluation and Research website for additional unpublished data, requested dossiers of information from pharmaceutical manufacturers, and retrieved relevant citations from reference lists of included studies. Study selection, data abstraction, validity assessment, grading the strength of the evidence, and data synthesis were all carried out according to our standard review methods. Overall, targeted immune modulators are highly effective medications for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis, Crohn's disease, ulcerative colitis, and plaque psoriasis that substantially improve the burden of disease and are generally safe for short-term treatment. For rheumatoid arthritis, low-and moderate-strength evidence indicated that some targeted immune modulators are more efficacious than others. These results were based on three head-to-head trials, several large observational studies, and indirect comparisons of placebo-controlled trials. The evidence is currently insufficient to reliably determine the comparative effectiveness for other indications and in subgroups. Low-strength evidence indicated that serious infections are less common with abatacept than the other drugs and that the rate of adverse events is greater with infliximab than adalimumab or etanercept. Likewise, more patients receiving infliximab withdrew due to adverse events than abatacept, adalimumab, etanercept, and golimumab. Infusion or allergic reactions contributed to the difference in risk.  
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  Notes PMID:23166955 Approved no  
  Call Number ref @ user @ Serial 74323  
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Author Donahue, K.E.; Jonas, D.E.; Hansen, R.A.; Roubey, R.; Jonas, B.; Lux, L.J.; Gartlehner, G.; Harden, E.; Wilkins, T.; Peravali, V.; Bangdiwala, S.I.; Yuen, A.; Thieda, P.; Morgan, L.C.; Crotty, K.; Desai, R.; Van Noord, M. url  openurl
  Title (up) Type Book
  Year 2012 Publication Abbreviated Journal  
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  Abstract Compare the benefits and harms of corticosteroids, oral and biologic disease-modifying antirheumatic drugs (DMARDs) for adults with rheumatoid arthritis. English-language articles from 1980 to February 2011 identified through PubMed, Embase, Cochrane Library, and International Pharmaceutical Abstracts; unpublished literature including dossiers from pharmaceutical companies. Two people independently selected relevant head-to-head trials of any sample size, prospective cohort studies with at least 100 participants, and relevant good- or fair-quality meta-analyses that compared benefits or harms of 14 drug therapies. Retrospective cohort studies were also included for harms. For biologic DMARDs, placebo-controlled, double-blind RCTs were also included. We required trials and cohort studies to have a study duration of at least 12 weeks. Literature was synthesized qualitatively within and between the two main drug classes (oral and biologic DMARDs). Network meta-analysis also was performed to examine the relative efficacy of biologic DMARDs and comparing withdrawal rates from placebo controlled trials. Head-to-head trials showed no clinically important differences in efficacy among oral DMARD comparisons (methotrexate, sulfasalazine, leflunomide). The only head-to-head trial comparing biologic DMARDs (abatacept vs. infliximab) found no clinically important differences. Combination therapy of biologic DMARDs plus methotrexate improved clinical response rates and functional capacity more than monotherapy with methotrexate. Network meta-analyses found higher odds of reaching ACR 50 response for etanercept compared with most other biologic DMARDs (abatacept, adalimumab, anakinra, infliximab, rituximab, tocilizumab) for methotrexate-resistant patients with active rheumatoid arthritis. Similar overall tolerability profiles were found among oral and biologic DMARDs, but short-term adverse events were more common with biologic DMARDs. Adjusted indirect comparisons of biologic DMARDs found that certolizumab had the most favorable overall withdrawal profile, followed by etanercept and rituximab. Certolizumab had lower relative withdrawal rates due to lack of efficacy than adalimumab, anakinra, and infliximab. Certolizumab and infliximab had more, while etanercept had fewer withdrawals due to adverse events than most other drugs. Evidence was insufficient to assess comparative risk of serious adverse events among biologic DMARDs. Combinations of biologic DMARDs have higher rates of serious adverse events than biologic DMARD monotherapy. Limited data existed for subgroups. Limited head-to-head comparative evidence does not support one therapy over another for adults with rheumatoid arthritis. Network meta-analyses from placebo-controlled trials of biologics suggest some differences, including higher odds of reaching ACR 50 response, but strength of evidence was low.  
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  Notes PMID:22696776 Approved no  
  Call Number ref @ user @ Serial 74417  
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Author Donahue, K.E.; Jonas, D.; Hansen, R.A.; Roubey, R.; Jonas, B.; Lux, L.J.; Gartlehner, G.; Harden, E.; Yuen, A.; Thieda, P.; Morgan, L.C.; Crotty, K.; Van Noord, M. url  openurl
  Title (up) Type Book
  Year 2012 Publication Abbreviated Journal  
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  Abstract To compare the benefits and harms of corticosteroids and oral and biologic disease-modifying antirheumatic drugs (DMARDs) for adults with psoriatic arthritis (PsA). English language articles from 1980 to February 2011 identified through PubMed, Embase, Cochrane Library and International Pharmaceutical Abstracts; unpublished literature including dossiers from pharmaceutical companies. Two people independently selected relevant head-to-head trials of any sample size, observational studies with at least 100 participants, and relevant good- or fair-quality meta-analyses that compared benefits or harms of 14 drug therapies. Observational studies were included only for harms. For biologic DMARDs, placebo-controlled, double-blind randomized controlled trials (RCTs) also were included. We required trials and observational studies to be at least 12 weeks in duration. Literature was synthesized qualitatively within and between the two main drug classes (oral and biologic DMARDs). No head-to-head controlled trials meeting inclusion criteria existed for any drugs in this review for treating patients with PsA. The available evidence was limited to two head-to-head cohort studies and placebo-controlled trials. For oral DMARDs, including sulfasalazine and methotrexate, the sparse data available involved placebo comparisons. For biologic DMARDs, evidence supported the efficacy of adalimumab, etanercept, golimumab, and infliximab for the treatment of PsA when compared with placebo. Qualitatively, these biologic DMARDs appeared to achieve similar improvements in disease activity, functional capacity, and health-related quality of life (American College of Rheumatology 20 percent improvement from baseline to endpoint, Health Assessment Questionnaire, and Short Form 36 Physical Component scores) in these trials. No difference in treatment response was found between the combination of an anti-tumor necrosis factor (TNF) (adalimumab, etanercept, or infliximab) with methotrexate compared with anti-TNF only. Evidence was insufficient to draw conclusions about the comparative harms for oral DMARDs. Among biologics, low evidence indicated that etanercept had a lower rate of withdrawals due to adverse events compared with infliximab. Compared with placebo, adalimumab and etanercept had more injection site reactions and adalimumab had few events of aggravated psoriasis. No comparative evidence was identified for subgroups. Overall, the data are quite limited and the evidence is insufficient to draw firm conclusions on comparative efficacy, effectiveness, and harms of either oral or biologic DMARDs for PsA. This report's findings did not reveal any differences with current standard of care. Head-to-head (RCTs) are needed to establish the comparative efficacy and safety of different treatments with and without corticosteroids, oral DMARDs, and biologic DMARDs, to determine the best therapy to prevent or minimize debilitating joint damage and optimize quality of life for people with PsA.  
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  Notes PMID:22624163 Approved no  
  Call Number ref @ user @ Serial 74433  
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Author Hutfless, S.; Almashat, S.; Berger, Z.; Wilson, L.M.; Bonson, E.; Chen, Q.; Donath, E.; Herlong, F.; Puhan, M.A.; Selvaraj, S.; Tuskey, A.; Vasilescu, A.; Bass, E.B.; Worthington, M.; Shantha, G.P.S.; Lazarev, M. url  openurl
  Title (up) Type Book
  Year 2014 Publication Abbreviated Journal  
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  Abstract 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. We searched MEDLINE(R) (1966 through June 2011), Embase(R) (1974 through June 2011), and the Cochrane Central Register of Controlled Trials (Issue 2, 2011). Two reviewers independently reviewed titles, abstracts, and articles, and included English-language articles that reported on induction or maintenance of remission in placebo-controlled or head-to-head randomized controlled trials. We also included observational studies with a comparison group if they reported on the safety of treatment. Two reviewers extracted study information using standardized forms and independently assessed study quality. Efficacy was measured by induction and maintenance of remission. Remission was defined using the Crohn's Disease Activity Index, mucosal healing, the absence of Crohn's disease hospitalizations or surgeries, reduction of steroids, fistula healing, and patient-reported outcomes. A difference of 10 percentage points in the outcome between treatment groups was considered clinically meaningful. The safety outcomes of interest were mortality, occurrence of lymphomas and other cancers, infections, infusion- and injection-site reactions, and bone fractures for adults and children. Growth was an additional safety concern for children. We included 136 studies involving 148,733 patients. Twenty-three percent of trials directly compared different treatment strategies. The majority of trials excluded patients with mild disease and those with a history of surgical resection. The majority of trials allowed patients to take other Crohn's disease treatments during the trial. For adults, infliximab and 6-methyl-prednisolone were consistently favored over placebo across the induction and maintenance outcomes. Natalizumab and azathioprine were favored over placebo across the maintenance outcomes. Other comparisons either did not have more than one outcome reported or had inconsistent results. The quality of the safety evidence was poor due to poor reporting of the methods in trials and poor confounding control in observational studies, and no strong signals of harm were identified. For children, the strength of evidence was low or insufficient to support the efficacy of any medication to induce or maintain remission. No pediatric study reported on serious adverse events such as mortality, lymphoma, or other cancers. Measuring the efficacy of medications using multiple outcomes, infliximab and 6-methyl-prednisolone induce and maintain remission in adults with Crohn's disease. Natalizumab and azathioprine maintain remission. Comparing Crohn's disease medications directly using pragmatic clinical trials will help to understand the effectiveness of medications in clinical practice using outcomes other than the Crohn's Disease Activity Index.  
  Address  
  Corporate Author Thesis  
  Publisher Place of Publication Editor  
  Language English Summary Language Original Title  
  Series Editor Series Title Abbreviated Series Title  
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  Notes PMID:24696887 Approved no  
  Call Number ref @ user @ Serial 82603  
Permanent link to this record
 

 
Author Hutfless, S.; Almashat, S.; Berger, Z.; Wilson, L.M.; Bonson, E.; Chen, Q.; Donath, E.; Herlong, F.; Puhan, M.A.; Selvaraj, S.; Tuskey, A.; Vasilescu, A.; Bass, E.B.; Worthington, M.; Shantha, G.P.S.; Lazarev, M. url  openurl
  Title (up) Type Book
  Year 2014 Publication Abbreviated Journal  
  Volume Issue Pages  
  Keywords  
  Abstract 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. We searched MEDLINE(R) (1966 through June 2011), Embase(R) (1974 through June 2011), and the Cochrane Central Register of Controlled Trials (Issue 2, 2011). Two reviewers independently reviewed titles, abstracts, and articles, and included English-language articles that reported on induction or maintenance of remission in placebo-controlled or head-to-head randomized controlled trials. We also included observational studies with a comparison group if they reported on the safety of treatment. Two reviewers extracted study information using standardized forms and independently assessed study quality. Efficacy was measured by induction and maintenance of remission. Remission was defined using the Crohn's Disease Activity Index, mucosal healing, the absence of Crohn's disease hospitalizations or surgeries, reduction of steroids, fistula healing, and patient-reported outcomes. A difference of 10 percentage points in the outcome between treatment groups was considered clinically meaningful. The safety outcomes of interest were mortality, occurrence of lymphomas and other cancers, infections, infusion- and injection-site reactions, and bone fractures for adults and children. Growth was an additional safety concern for children. We included 136 studies involving 148,733 patients. Twenty-three percent of trials directly compared different treatment strategies. The majority of trials excluded patients with mild disease and those with a history of surgical resection. The majority of trials allowed patients to take other Crohn's disease treatments during the trial. For adults, infliximab and 6-methyl-prednisolone were consistently favored over placebo across the induction and maintenance outcomes. Natalizumab and azathioprine were favored over placebo across the maintenance outcomes. Other comparisons either did not have more than one outcome reported or had inconsistent results. The quality of the safety evidence was poor due to poor reporting of the methods in trials and poor confounding control in observational studies, and no strong signals of harm were identified. For children, the strength of evidence was low or insufficient to support the efficacy of any medication to induce or maintain remission. No pediatric study reported on serious adverse events such as mortality, lymphoma, or other cancers. Measuring the efficacy of medications using multiple outcomes, infliximab and 6-methyl-prednisolone induce and maintain remission in adults with Crohn's disease. Natalizumab and azathioprine maintain remission. Comparing Crohn's disease medications directly using pragmatic clinical trials will help to understand the effectiveness of medications in clinical practice using outcomes other than the Crohn's Disease Activity Index.  
  Address  
  Corporate Author Thesis  
  Publisher Place of Publication Editor  
  Language English Summary Language Original Title  
  Series Editor Series Title Abbreviated Series Title  
  Series Volume Series Issue Edition  
  ISSN ISBN Medium  
  Area Expedition Conference  
  Notes PMID:24696887 Approved no  
  Call Number ref @ user @ Serial 83103  
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