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Systematic review

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Serious Adverse Events and Spinal Manipulative Therapy of the Low Back Region: A Systematic Review of Cases

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Journal Journal of manipulative and physiological therapeutics
Year 2015
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This article is included in 1 Broad synthesis 0 Broad syntheses (1 reference)

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OBJECTIVE: The purpose of this study was to systematically search the literature for studies reporting serious adverse events following lumbopelvic spinal manipulative therapy (SMT) and to describe the case details. METHODS: A systematic search was conducted in PubMed including MEDLINE, EMBASE, CINAHL, and The Cochrane Library up to January 12, 2012, by an experienced reference librarian. Study selection was performed by 2 independent reviewers using predefined criteria. We included cases involving individuals 18 years or older who experienced a serious adverse event following SMT applied to the lumbar spine or pelvis by any type of provider (eg, chiropractic, medical, physical therapy, osteopathic, layperson). A serious adverse event was defined as an untoward occurrence that results in death or is life threatening, requires hospital admission, or results in significant or permanent disability. We included studies published in English, German, Dutch, and Swedish. RESULTS: A total of 2046 studies were screened, and 41 studies reporting on 77 cases were included. Important case details were frequently unreported, such as descriptions of SMT technique, the pre-SMT presentation of the patient, the specific details of the adverse event, time from SMT to the adverse event, factors contributing to the adverse event, and clinical outcome. Adverse events consisted of cauda equina syndrome (29 cases, 38% of total); lumbar disk herniation (23 cases, 30%); fracture (7 cases, 9%); hematoma or hemorrhagic cyst (6 cases, 8%); or other serious adverse events (12 cases, 16%) such as neurologic or vascular compromise, soft tissue trauma, muscle abscess formation, disrupted fracture healing, and esophageal rupture. CONCLUSIONS: This systematic review describes case details from published articles that describe serious adverse events that have been reported to occur following SMT of the lumbopelvic region. The anecdotal nature of these cases does not allow for causal inferences between SMT and the events identified in this review. Recommendations regarding future case reporting and research aimed at furthering the understanding of the safety profile of SMT are discussed.

Systematic review

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Indirect comparison of the effects of anti-TNF biological agents in patients with ankylosing spondylitis by means of a mixed treatment comparison performed on efficacy data from published randomised, controlled trials

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Journal Value in Health
Year 2014
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Objectives: To compare ASAS (Assessment in Ankylosing Spondylitis Response Criteria) 20 response patterns between anti-TNF biological agents in patients with ankylosing spondylitis by means of a mixed treatment comparison of different randomised, controlled trials (RCTs) on the efficacy of biological therapies. Methods: A systematic review of literature was performed to identify a number of similarly designed double-blind, randomized, placebo-controlled trials investigating the efficacy of the TNF-alfa inhibitors etanercept, infliximab, golimumab, certolizumab pegol and adalimumab in the treatment of ankylosing spondylitis patients, conducted over an 18-years period. The endpoint of interest was ASAS20 response criteria at 12 weeks. Results were analyzed simultaneously using Bayesian mixed treatment comparison techniques. Results were expressed as odds ratio (OR) of ASAS20 response and associated 95% credible intervals (CrIs). The probability of being the best treatment was also reported. Results: 6 RCTs were selected for data extraction and further analysis. By mean of MTC, all anti-TNF agents demonstrated to be more efficacious in inducing a ASAS20 response than placebo. Infliximab shows a 67,6% of probability of being the best treatment of all. Adalimumab, golimumab and etanercept show probabilities of 17,7%, 10,6% and 4%, respectively, while certolizumab pegol showed a probability of being the best treatment of 0,1%. No differences were observed when comparing directly an anti-TNFalfa agent against another. Conclusions: Even if the mixed treatment comparisons between infliximab, golimumab, certolizumab pegol, adalimumab and etanercept did not show a statistically significant difference, this analysis suggests that infliximab, compared to placebo, is expected to provide the highest rate of ASAS20 response in SA patients naive to biologic treatments.

Systematic review

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Treating axial and peripheral spondyloarthritis, including psoriatic arthritis, to target: Results of a systematic literature search to support an international treat-to-target recommendation in spondyloarthritis

Journal Annals of the rheumatic diseases
Year 2014
Links Pubmed DOI PubMed Central

This article is included in 2 Broad syntheses 22 Broad syntheses (2 references)

This article includes 22 Primary studies 22 Primary studies (22 references)

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Background Current recommendations for the management of axial spondyloarthritis (SpA) and psoriatic arthritis are to monitor disease activity and adjust therapy accordingly. However, treatment targets and timeframes of change have not been defined. An international expert panel has been convened to develop 'treat-to-target' recommendations, based on published evidence and expert opinion. Objective To review evidence on targeted treatment for axial and peripheral SpA, as well as for psoriatic skin disease. Methods We performed a systematic literature search covering Medline, Embase and Cochrane, conference abstracts and studies in http://www.clinicaltrials.gov. Results Randomised comparisons of targeted versus routine treatment are lacking. Some studies implemented treatment targets before escalating therapy: in ankylosing spondylitis, most trials used a decrease in Bath Ankylosing Spondylitis Disease Activity Index; in psoriatic arthritis, protocols primarily considered a reduction in swollen and tender joints; in psoriasis, the Modified Psoriasis Severity Score and the Psoriasis Area and Severity Index were used. Complementary evidence correlating these factors with function and radiographic damage at follow-up is sparse and equivocal. Conclusions There is a need for randomised trials that investigate the value of treat-to-target recommendations in SpA and psoriasis. Several trials have used thresholds of disease activity measures to guide treatment decisions. However, evidence on the effect of these data on long-term outcome is scarce. The search data informed the expert committee regarding the formulation of recommendations and a research agenda.

Systematic review

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Treatment of ankylosing spondylitis with TNF blockers: a meta-analysis.

Journal Rheumatology international
Year 2013
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This article is included in 2 Broad syntheses 19 Broad syntheses (2 references)

This article includes 26 Primary studies 19 Primary studies (26 references)

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Biological agents directed against tumor necrosis factor (TNF) represent therapeutic options for patients with ankylosing spondylitis with high disease activity despite use of non-steroidal anti-inflammatory drugs. To evaluate the efficacy and safety of the anti-TNF agents infliximab, etanercept, adalimumab, golimumab, and certolizumab for the treatment of ankylosing spondylitis, we performed a systematic review of randomized clinical trials on adult patients with ankylosing spondylitis using articles culled from the EMBASE, MEDLINE, Cochrane Controlled Trials Register and LILACS databases (September/2012), manual literature search, and the gray literature. Study selections and data collection were performed by two independent reviewers, with disagreements solved by a third reviewer. The following outcomes were evaluated: ASAS 20 response, disease activity, physical function, vertebral mobility, adverse events, and withdraws. The meta-analysis was performed using the Review Manager(®) 5.1 software by applying the random effects model. Eighteen studies were included in this review. No study of certolizumab was included. Patients treated with anti-TNF agents were more likely to display an ASAS 20 response after 12/14 weeks (RR 2.21; 95 % CI 1.91; 2.56) and 24 weeks (RR 2.68; 95 % CI 2.06; 3.48) compared with controls, which was also true for several other efficacy outcomes. Meta-analysis of safety outcomes and withdraws did not indicate statistically significant differences between treatment and control groups after 12 or 30 weeks. Adalimumab, infliximab, etanercept, and golimumab can effectively reduce the signs and symptoms of the axial component of ankylosing spondylitis. Safety outcomes deserve further study, especially with respect to long-term follow-ups.

Systematic review

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Efficacy of antitumor necrosis factor(α) agents on patients with ankylosing spondylitis

Authors Ren L , Li J , Luo R , Tang R , Zhu S , Wan L
Journal The American journal of the medical sciences
Year 2013
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This article is included in 2 Broad syntheses 12 Broad syntheses (2 references)

This article includes 12 Primary studies 12 Primary studies (12 references)

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OBJECTIVES:: This study was designed to investigate the efficacy of antitumor necrosis factor(TNF)(a) agents (etanercept, infliximab, golimumab or adalimumab) in ankylosing spondylitis (AS). METHODS:: A literature search was done using PubMed, Embaseand Cochrane databases. The reference section of all primary studies was inspected for additional references, and only those reporting the results of a randomized-controlled trial comparing etanercept, infliximab or adalimumab with placebo for patients with AS were included in this analysis. RESULTS:: Eleven trials with 1851 patients were included. Compared with placebo, anti-TNF(α) agents was associated with significantly higher rates of Assessment in Ankylosing Spondylitis (ASAS) 20 responders (risk ratio [RR]: 2.45, 95% confidence interval [CI]: 2.13-2.82; P < 0.00001), ASAS 50 responders (RR: 3.77, 95% CI: 2.87-4.95; P < 0.00001), ASAS 70 responders (RR: 3.25, 95% CI: 1.97-5.35; P < 0.00001) and patients with partial remission (RR: 5.39, 95% CI: 3.25-8.93; P < 0.00001). In addition, there were more patients with at least 50% improvement in the Bath Ankylosing Spondylitis Disease Activity Index score in the experimental groups (RR: 3.07, 95% CI: 2.44-3.86; P < 0.00001). Most adverse events in both treatment groups were mild or moderate in severity. CONCLUSIONS:: Anti-TNF(a) agents is an effective and well-tolerated treatment for reducing clinical symptoms of AS. © 2013 Lippincott Williams & Wilkins.

Systematic review

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Adverse events and manual therapy: a systematic review.

Journal Manual therapy
Year 2010
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This article is included in 1 Structured summary of systematic reviews 0 Structured summaries of systematic reviews (1 reference) 3 Broad syntheses 0 Broad syntheses (3 references)

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OBJECTIVE: To explore the incidence and risk of adverse events with manual therapies. METHOD: The main health electronic databases, plus those specific to allied medicine and manual therapy, were searched. Our inclusion criteria were: manual therapies only; administered by regulated therapists; a clearly described intervention; adverse events reported. We performed a meta-analysis using incident estimates of proportions and random effects models. RESULTS: Eight prospective cohort studies and 31 manual therapy RCTs were accepted. The incidence estimate of proportions for minor or moderate transient adverse events after manual therapy was approximately 41% (CI 95% 17-68%) in the cohort studies and 22% (CI 95% 11.1-36.2%) in the RCTs; for major adverse events approximately 0.13%. The pooled relative risk (RR) for experiencing adverse events with exercise, or with sham/passive/control interventions compared to manual therapy was similar, but for drug therapies greater (RR 0.05, CI 95% 0.01-0.20) and less with usual care (RR 1.91, CI 95% 1.39-2.64). CONCLUSIONS: The risk of major adverse events with manual therapy is low, but around half manual therapy patients may experience minor to moderate adverse events after treatment. The relative risk of adverse events appears greater with drug therapy but less with usual care.

Systematic review

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Differences in the incidence of flares or new onset of inflammatory bowel diseases in patients with ankylosing spondylitis exposed to therapy with anti-tumor necrosis factor alpha agents.

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Journal Arthritis and rheumatism
Year 2007
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OBJECTIVE: Ankylosing spondylitis (AS) and inflammatory bowel disease (IBD) are clinically and pathologically linked. Anti-tumor necrosis factor (anti-TNF) agents are efficacious in treating AS, but not all are equally effective in treating IBD (Crohn's disease [CD] and ulcerative colitis [UC]). The purpose our study was to analyze the incidence of flares and new onset of IBD in patients with AS treated with anti-TNF agents. METHODS: Data from 9 trials, 7 placebo-controlled trials and 2 open studies, were analyzed. RESULTS: Data were available on 419 AS patients exposed to etanercept (625 patient-years), 366 exposed to infliximab (618 patient-years), 295 exposed to adalimumab (132 patient-years), and 434 placebo patients (150 patient-years). A history of IBD was reported in 76 of 1,130 patients (6.7%). There were 2 reports of IBD while receiving placebo (1.3 per 100 patient-years), 1 while receiving infliximab, and 3 while receiving adalimumab. Among the 14 IBD cases receiving etanercept (2.2 per 100 patient-years) there were 8 CD and 6 UC cases, significantly different from infliximab (P = 0.01) but not from placebo. Patients with a history of IBD had an IBD flare odds ratio of 18.0 (95% confidence interval [95% CI] 2-154) while taking etanercept and 4.2 (95% CI 0.4-44) while taking adalimumab, in comparison with infliximab. The incidence rates of new onset of IBD showed no significant difference between etanercept (0.8 per 100 patient-years) and placebo (0.5 per 100 patient-years). CONCLUSION: New onset and flare of IBD are infrequent events in AS patients receiving anti-TNF therapy. Infliximab (but not etanercept) largely prevents IBD activity. More data are required for adalimumab. The incidence of new onset of IBD was statistically not different from placebo for all anti-TNF agents.

Systematic review

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Adverse effects of spinal manipulation: a systematic review.

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Authors Ernst E
Journal Journal of the Royal Society of Medicine
Year 2007
Links Pubmed DOI PubMed Central

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This article is included in 2 Broad syntheses 0 Broad syntheses (2 references)

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OBJECTIVE: To identify adverse effects of spinal manipulation. DESIGN: Systematic review of papers published since 2001. SETTING: Six electronic databases. MAIN OUTCOME MEASURES: Reports of adverse effects published between January 2001 and June 2006. There were no restrictions according to language of publication or research design of the reports. RESULTS: The searches identified 32 case reports, four case series, two prospective series, three case-control studies and three surveys. In case reports or case series, more than 200 patients were suspected to have been seriously harmed. The most common serious adverse effects were due to vertebral artery dissections. The two prospective reports suggested that relatively mild adverse effects occur in 30% to 61% of all patients. The case-control studies suggested a causal relationship between spinal manipulation and the adverse effect. The survey data indicated that even serious adverse effects are rarely reported in the medical literature. CONCLUSIONS: Spinal manipulation, particularly when performed on the upper spine, is frequently associated with mild to moderate adverse effects. It can also result in serious complications such as vertebral artery dissection followed by stroke. Currently, the incidence of such events is not known. In the interest of patient safety we should reconsider our policy towards the routine use of spinal manipulation.

Systematic review

Unclassified

Adalimumab, etanercept and infliximab for the treatment of ankylosing spondylitis: a systematic review and economic evaluation.

Journal Health technology assessment (Winchester, England)
Year 2007
Links Pubmed DOI Google Scholar

This article is included in 1 Structured summary of systematic reviews 19 Structured summaries of systematic reviews (1 reference) 3 Broad syntheses 19 Broad syntheses (3 references)

This article includes 38 Primary studies 19 Primary studies (38 references)

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OBJECTIVES: To assess the comparative clinical effectiveness and cost-effectiveness of adalimumab, etanercept and infliximab for the treatment of ankylosing spondylitis (AS). DATA SOURCES: Major electronic databases were searched up to November 2005. Unpublished evidence such as conference abstracts, reviews of published economic evaluations, and company submissions to the National Institute for Health and Clinical Excellence (NICE) were also reviewed. REVIEW METHODS: The assessment was conducted according to accepted procedures for conducting and reporting systematic reviews and economic evaluations. Full economic evaluations that compared two or more options for treatment and considered both costs and consequences were eligible for inclusion in the economic literature review. RESULTS: Nine placebo controlled randomised controlled trials (RCTs) were included in the review of clinical effects. These included two studies of adalimumab, five of etanercept and two of infliximab in comparison with placebo (along with conventional management). No RCTs directly comparing anti-tumour necrosis factor-alpha (TNF-alpha) agents were identified. Meta-analyses were conducted for data on Assessment in Ankylosing Spondylitis (ASAS) (20, 50 and 70% improvement), mean change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and mean change in Bath Ankylosing Spondylitis Functional Index (BASFI) at 12 weeks following initiation of anti-TNF-alpha therapy or placebo for all three drugs. Meta-analyses were also conducted at 24 weeks for etanercept and infliximab. Each meta-analysis of anti-TNF-alpha therapy demonstrated statistically significant advantages over placebo, although there was no significant difference between individual anti-TNF-alpha agents. At 12 weeks, ASAS 50% responses were 3.6-fold more likely with anti-TNF-alpha treatment than placebo. Compared with baseline, BASDAI scores were reduced by close to 2 points at 12 weeks. Functional scores (BASFI) were reduced at 12 weeks. Six full economic evaluations (two peer-reviewed published papers, four abstracts) were included in the review. The conclusions among economic evaluations were mixed, although the balance of evidence indicates that over short time-frames anti-TNF-alpha therapies are unlikely to be considered cost-effective. The limitations of the clinical outcome data impose restrictions on the economic assessment of cost-effectiveness. Direct unbiased RCT evidence is only available in the short term. Current assessment tools are limited and at present BASDAI and BASFI are the best available, although not designed for, or ideal for, use in economic evaluations. The review of the three models submitted to NICE identified a number of inherent flaws and errors. The incremental cost-effectiveness ratios (ICERs) of etanercept and adalimumab were roughly similar, falling below an assumed willingness-to-pay threshold of 30,000 pounds. The ICER for infliximab was in the range of 40,000-50,000 pounds per quality-adjusted life-year (QALY). The short-term (12-month) model developed by this report's authors confirmed the large front-loading of costs with a result that none of the three anti-TNF-alpha agents appears cost-effective at the current acceptable threshold, with infliximab yielding much poorer economic results (57,000-120,000 pounds per QALY). The assumptions of the short-term model were used to explore the cost-effectiveness of the use of anti-TNF-alpha agents in the long term. This model is far more speculative than the first since trends and parameter values must be projected far beyond the available evidence. Sensitivity analyses reveal wide variations in estimates of cost over the long term although it is considered unlikely that costs will decrease over time. CONCLUSIONS: The review of clinical data related to the three drugs (including conventional treatment) compared with conventional treatment plus placebo indicates that in the short term (12-24 weeks), the three treatments are clinically effective in relation to assessment of ASAS, BASDAI and BASFI. Indirect comparisons of treatments were limited and did not show a significant difference in effectiveness between the three agents. The short-term economic assessment indicates that none of the three anti-TNF-alpha agents is likely to be considered cost-effective at current acceptability thresholds, with infliximab consistently the least favourable option. There is an absence of evidence concerning a number of limiting factors related to patients suffering from AS, the disease itself and its treatment. In order to obtain robust estimates of the longer term clinical effectiveness and cost-effectiveness of anti-TNF-alpha agents for AS, clinical trials that aim to address these limiting factors need to be conducted. Executive summary and full-text available for free by visiting the document URL listed with this record.

Systematic review

Unclassified

Decreased incidence of anterior uveitis in patients with ankylosing spondylitis treated with the anti-tumor necrosis factor agents infliximab and etanercept.

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Journal Arthritis and rheumatism
Year 2005
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This article is included in 2 Broad syntheses 7 Broad syntheses (2 references)

This article includes 7 Primary studies 7 Primary studies (7 references)

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OBJECTIVE: To estimate the incidence of anterior uveitis in patients with ankylosing spondylitis (AS) who underwent anti-tumor necrosis factor (anti-TNF) therapy, using data from recently performed trials. METHODS: Data from 4 placebo-controlled studies with anti-TNF agents in AS (2 with etanercept and 2 with infliximab) and 3 open-label studies were analyzed for the prestudy prevalence and the incidence of reported flares of anterior uveitis. RESULTS: A total of 717 patients who received treatment for anterior uveitis during the course of published clinical studies were identified by a systematic literature search using Medline. Followup information on the course of anterior uveitis was available for 397 patients. Of these, 297 were exposed to etanercept and 90 were exposed to infliximab for a total of 430 and 146.4 years, respectively. Among 190 patients who received placebo, the overall exposure was 70.5 years. The frequency of flares of anterior uveitis in the placebo group was 15.6 per 100 patient-years (95% confidence interval 7.8-27.9), while the patients treated with anti-TNF agents had a mean of only 6.8 anterior uveitis flares per 100 patient-years (P = 0.01). Flares of anterior uveitis occurred less frequently (although not significantly) in patients treated with infliximab than in patients treated with etanercept (3.4 per 100 patient-years and 7.9 per 100 patient-years, respectively). CONCLUSION: Treatment of AS patients with biologic agents directed against TNFalpha is associated with a significant decrease in the number of anterior uveitis flares. This reduction was slightly more marked among patients treated with infliximab, but the difference was not significant.