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Frontiers in Oncology 2021Given the expanding clinical applications of laparoscopic surgery and neoadjuvant chemotherapy in advanced gastric cancer treatment, there is an emerging need to...
BACKGROUND
Given the expanding clinical applications of laparoscopic surgery and neoadjuvant chemotherapy in advanced gastric cancer treatment, there is an emerging need to summarize the few evidences that evaluated the safety and efficacy of laparoscopic versus open gastrectomy in patients with advanced gastric cancer (AGC) following neoadjuvant chemotherapy (NAC).
METHODS
From January 1 to 2, 2021, we searched Ovid Embase, PubMed, Cochrane central register Trials (Ovid), and web of science to find relevant studies published in English, and two authors independently performed literature screening, quality assessment of the included studies, data extraction, and data analysis. This study was registered with PROSPERO (CRD42021228845).
RESULTS
The initial search retrieved 1567 articles, and 6 studies were finally included in the meta-analysis review, which comprised 2 randomized control trials and 4 observational studies involving 288 laparoscopic gastrectomy (LG) and 416 open gastrectomy (OG) AGC patients treated with NAC. For intraoperative conditions, R0 resection rate, blood transfusion, intraoperative blood loss, number of lymph nodes dissected, proximal margin, and distal margin were comparable between LG group and open OG group. For postoperative short-term clinical outcomes, LG has significantly less postoperative complications (OR = 0.65, 95%CI: 0.42-1.00, p = 0.05) and shorter postoperative time to first aerofluxus (WMD = -0.57d, 95%CI: -0.89-0.25, p = 0.0004) than OG, and anastomotic leakage, pulmonary infection, pleural effusion, surgical site infection, thrombosis, intestinal obstruction, peritoneal effusion or abscess formation, postoperative time to first defecation, postoperative time to first liquid diet, and postoperative length of stay were comparable between the two groups. For postoperative survival outcomes, there were no significant differences in disease-free survival (DFS) and overall survival (OS) between the two groups.
CONCLUSION
The available evidences indicated that LG is an effective and feasible technology for the treatment of AGC patients treated with NAC, and LG patients have much less postoperative complications and faster bowel function recovery than OG patients.
SYSTEMATIC REVIEW REGISTRATION
PROSPERO database (identifier, CRD42021228845).
PubMed: 34422658
DOI: 10.3389/fonc.2021.704244 -
The Cochrane Database of Systematic... May 2018Appendectomy, the surgical removal of the appendix, is performed primarily for acute appendicitis. Patients who undergo appendectomy for complicated appendicitis,... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Appendectomy, the surgical removal of the appendix, is performed primarily for acute appendicitis. Patients who undergo appendectomy for complicated appendicitis, defined as gangrenous or perforated appendicitis, are more likely to suffer from postoperative complications. The routine use of abdominal drainage to reduce postoperative complications after appendectomy for complicated appendicitis is controversial.This is an update of the review first published in 2015.
OBJECTIVES
To assess the safety and efficacy of abdominal drainage to prevent intra-peritoneal abscess after open appendectomy for complicated appendicitis.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library, 2017, Issue 6), Ovid MEDLINE (1946 to 30 June 2017), Ovid Embase (1974 to 30 June 2017), Science Citation Index Expanded (1900 to 30 June 2017), World Health Organization International Clinical Trials Registry Platform (30 June 2017), ClinicalTrials.gov (30 June 2017) and Chinese Biomedical Literature Database (CBM) (1978 to 30 June 2017).
SELECTION CRITERIA
We included all randomised controlled trials (RCTs) that compared abdominal drainage and no drainage in people undergoing emergency open appendectomy for complicated appendicitis.
DATA COLLECTION AND ANALYSIS
Two review authors identified the trials for inclusion, collected the data, and assessed the risk of bias independently. We performed the meta-analyses using Review Manager 5. We calculated the risk ratio (RR) for dichotomous outcomes (or a Peto odds ratio for very rare outcomes), and the mean difference (MD) for continuous outcomes with 95% confidence intervals (CI). We used GRADE to rate the quality of evidence.
MAIN RESULTS
We included six RCTs (521 participants), comparing abdominal drainage and no drainage in patients undergoing emergency open appendectomy for complicated appendicitis. The studies were conducted in North America, Asia and Africa. The majority of the participants had perforated appendicitis with local or general peritonitis. All participants received antibiotic regimens after open appendectomy. None of the trials was at low risk of bias.There was insufficient evidence to determine the effects of abdominal drainage and no drainage on intra-peritoneal abscess at 14 days (RR 1.23, 95% CI 0.47 to 3.21; 5 RCTs; 453 participants; very low-quality evidence) or for wound infection at 14 days (RR 2.01, 95% CI 0.88 to 4.56; 5 RCTs; 478 participants; very low-quality evidence). The increased risk of 30-day overall complication rate (morbidity) in the drainage group was rated as very low-quality evidence (RR 6.67, 95% CI 2.13 to 20.87; 1 RCT; 90 participants). There were seven deaths in the drainage group (N = 183) compared to one in the no drainage group (N = 180), equating to an increase in the risk of 30-day mortality from 0.6% to 2.7% (Peto odds ratio (OR) 4.88, 95% CI 1.18 to 20.09; 4 RCTs; 363 participants; moderate-quality evidence). There is 'very low-quality' evidence that drainage increases hospital stay compared to the no drainage group by 2.17 days (95% CI 1.76 to 2.58; 3 RCTs; 298 participants).Other outlined outcomes, hospital costs, pain, and quality of life, were not reported in any of the included studies.
AUTHORS' CONCLUSIONS
The quality of the current evidence is very low. The effect of abdominal drainage on the prevention of intra-peritoneal abscess or wound infection after open appendectomy is uncertain for patients with complicated appendicitis. The increased rates for overall complication rate and hospital stay for the drainage group compared to no drainage group is also subject to great uncertainty. Thus, there is no evidence for any clinical improvement by using abdominal drainage in patients undergoing open appendectomy for complicated appendicitis. The increased risk of mortality with drainage comes from eight deaths observed in just under 400 people recruited to the studies. Larger studies are needed to determine the effects of drainage on morbidity and mortality outcomes more reliably.
Topics: Abdominal Abscess; Appendectomy; Appendicitis; Drainage; Emergencies; Humans; Length of Stay; Peritoneal Diseases; Postoperative Complications; Randomized Controlled Trials as Topic
PubMed: 29741752
DOI: 10.1002/14651858.CD010168.pub3 -
Medicine Jan 2015To this day, the treatment of generalized peritonitis secondary to diverticular perforation is still controversial. Recently, in patients with acute sigmoid... (Meta-Analysis)
Meta-Analysis Review
To this day, the treatment of generalized peritonitis secondary to diverticular perforation is still controversial. Recently, in patients with acute sigmoid diverticulitis, laparoscopic lavage and drainage has gained a wide interest as an alternative to resection. Based on this backdrop, we decided to perform a systematic review of the literature to evaluate the safety, feasibility, and efficacy of peritoneal lavage in perforated diverticular disease.A bibliographic search was performed in PubMed for case series and comparative studies published between January 1992 and February 2014 describing laparoscopic peritoneal lavage in patients with perforated diverticulitis.A total of 19 articles consisting of 10 cohort studies, 8 case series, and 1 controlled clinical trial met the inclusion criteria and were reviewed. In total these studies analyzed data from 871 patients. The mean follow-up time ranged from 1.5 to 96 months when reported. In 11 studies, the success rate of laparoscopic peritoneal lavage, defined as patients alive without surgical treatment for a recurrent episode of diverticulitis, was 24.3%. In patients with Hinchey stage III diverticulitis, the incidence of laparotomy conversion was 1%, whereas in patients with stage IV it was 45%. The 30-day postoperative mortality rate was 2.9%. The 30-day postoperative reintervention rate was 4.9%, whereas 2% of patients required a percutaneous drainage. Readmission rate after the first hospitalization for recurrent diverticulitis was 6%. Most patients who were readmitted (69%) required redo surgery. A 2-stage laparoscopic intervention was performed in 18.3% of patients.Laparoscopic peritoneal lavage should be considered an effective and safe option for the treatment of patients with sigmoid diverticulitis with Hinchey stage III peritonitis; it can also be consider as a "bridge" surgical step combined with a delayed and elective laparoscopic sigmoidectomy in order to avoid a Hartmann procedure. This minimally invasive staged approach should be considered for patients without systemic toxicity and in centers experienced in minimally invasive surgery techniques. Further evidence is needed, and the ongoing RCTs will better define the role of the laparoscopic peritoneal lavage/drainage in the treatment of patients with complicated diverticulitis.
Topics: Colectomy; Diverticulitis, Colonic; Humans; Laparoscopy; Peritoneal Lavage; Peritonitis
PubMed: 25569649
DOI: 10.1097/MD.0000000000000334 -
Cureus Jan 2024Dialysis in pediatric groups is complicated by a wide range of factors that can affect long-term prognosis. The purpose of this meta-analysis and systematic review is to... (Review)
Review
Dialysis in pediatric groups is complicated by a wide range of factors that can affect long-term prognosis. The purpose of this meta-analysis and systematic review is to better understand the demographic and clinical factors that affect dialysis success in children. We searched a variety of databases for relevant articles and included 14 reports that dealt with the case studies of pediatric patients undergoing dialysis for a wide range of renal diseases. Patients' demographics, clinical presentations, laboratory findings, and treatment outcomes were the primary areas of data collection. To get a better sense of the overall prevalence of certain outcomes and to spot noteworthy trends or patterns in the disease process, we conducted a meta-analysis. Variations in dialysis efficacy and outcomes are highlighted throughout a wide range of ages in the pediatric dialysis cohort, from neonates to teenagers. Acute kidney injuries (AKI) tended to impact more boys, but chronic kidney diseases (CKD), such as lupus nephritis, disproportionately afflicted girls. Many different ethnic groups were represented, and there was evidence that some diseases having a hereditary component were more common in some areas than others. However, the potential for long-term consequences remained a concern. Hemodialysis was found to be effective in controlling end-stage renal disease (ESRD) and AKI, with some patients going on to have a kidney transplant. At the same time, peritoneal dialysis was associated with an increased risk of infection. This comprehensive analysis highlights the importance of demographic and clinical parameters in determining pediatric dialysis outcomes. A 14.47% mortality rate and gender disparities are revealed by this meta-analysis of pediatric renal diseases, which included a cohort of 235 patients with conditions like lupus nephritis and hepatitis C infection. The findings stress the necessity for individualized treatment techniques and suggest that demographic characteristics should be addressed in prognostic models. For better patient outcomes, the study also suggests standardized reporting in pediatric dialysis studies.
PubMed: 38344624
DOI: 10.7759/cureus.51978 -
International Journal of Colorectal... Aug 2021The aim of this study was to compare the outcomes of right hemicolectomy with CME performed with laparoscopic and open surgery. (Meta-Analysis)
Meta-Analysis Review
PURPOSE
The aim of this study was to compare the outcomes of right hemicolectomy with CME performed with laparoscopic and open surgery.
METHODS
PubMed, Scopus, Web of Science, China National Knowledge Infrastructure, Wanfang Data, Google Scholar and the ClinicalTrials.gov register were searched. Primary outcome was the overall number of harvested lymph nodes. Secondary outcomes were short and long-term course variables. A meta-analysis was performed to calculate risk ratios.
RESULTS
Twenty-one studies were identified with 5038 patients enrolled. The difference in number of harvested lymph nodes was not statistically significant (MD 0.68, - 0.41-1.76, P = 0.22). The only RCT shows a significant advantage in favour of laparoscopy (MD 3.30, 95% CI - 0.20-6.40, P = 0.04). The analysis of CCTs showed an advantage in favour of the laparoscopic group, but the result was not statically significantly (MD - 0.55, 95% CI - 0.57-1.67, P = 0.33). The overall incidence of local recurrence was not different between the groups, while systemic recurrence at 5 years was lower in laparoscopic group. Laparoscopy showed better short-term outcomes including overall complications, lower estimated blood loss, lower wound infections and shorter hospital stay, despite a longer operative time. The rate of anastomotic and chyle leak was similar in the two groups.
CONCLUSIONS
Despite the several limitations of this study, we found that the median number of lymph node harvested in the laparoscopic group is not different compared to open surgery. Laparoscopy was associated with a lower incidence of systemic recurrence.
Topics: China; Colectomy; Colonic Neoplasms; Humans; Laparoscopy; Length of Stay; Lymph Node Excision; Mesocolon; Neoplasm Recurrence, Local; Operative Time; Treatment Outcome
PubMed: 33644837
DOI: 10.1007/s00384-021-03891-0 -
Tuberkuloz Ve Toraks Dec 2021Kidney transplant recipients and dialysis patients constitute a risk group for severe COVID-19. They are highly advised to get vaccinated according to the current...
Kidney transplant recipients and dialysis patients constitute a risk group for severe COVID-19. They are highly advised to get vaccinated according to the current guidelines. However, data on antibody response, cell responses and protection from events, and factors that might alter this response after a routine full series of vaccination remain incomplete for these populations. The aim of this article was to analyze the antibody responses after a full series of mRNA-based SARS-CoV-2 vaccination in kidney transplantation and dialysis patients and to define the factors that alter seroconversion status in these populations. In this systematic review, 18 studies investigating the antibody response to full vaccination with two doses of COVID-19 mRNA vaccines in hemodialysis, peritoneal dialysis, and kidney transplant patients were included. Kidney transplant and dialysis patients have a lower seroconversion rate after mRNA-based SARS-CoV-2 vaccination than the healthy population: 27.2% for kidney transplantation, 88.5% for dialysis patients while all healthy control in these studies seroconverted. Moreover, anti-S antibody titers were lower in seroconverted kidney transplantation or dialysis patients than in healthy control in all studies that assessed this variable. Older age and dialysis vintage, immunosuppressive or chemotherapy treatment, and lower serum albumin, white blood cell, lymphocyte and hemoglobin counts were associated with lower/no antibody response to vaccination. Dialysis patients and kidney transplant recipients have lower seroconversion rates after a full series of mRNA-based SARS-CoV-2 vaccination than the general population. Several factors are associated with an altered antibody response. A third dose could be considered in this patient group.
Topics: Aged; COVID-19; COVID-19 Vaccines; Humans; Kidney Transplantation; Renal Dialysis; SARS-CoV-2; Vaccines, Synthetic; mRNA Vaccines
PubMed: 34957748
DOI: 10.5578/tt.20219612 -
Cureus Mar 2023Multidrug-resistant/rifampicin-resistant tuberculosis (MDR/RR TB) is a global concern, with 450,000 new cases and 191,000 deaths in 2021. TB and chronic kidney disease... (Review)
Review
Multidrug-resistant/rifampicin-resistant tuberculosis (MDR/RR TB) is a global concern, with 450,000 new cases and 191,000 deaths in 2021. TB and chronic kidney disease (CKD) have been associated since 1974, with suggested explanations such as oxidative stress, malnutrition, dysfunction in vitamin D metabolism, and a compromised cell-mediated immune response. End-stage renal failure patients are more likely to acquire drug resistance due to poor adherence, adverse drug reactions, and inappropriate dose adjustment. We then aim to evaluate the therapeutic outcome of multidrug-resistant TB of the lungs in patients who require hemodialysis in terms of successful treatment (cured and treatment completed) and the associated factors for a favorable outcome. Our secondary goal is to identify unfavorable treatment outcomes (treatment failed, patient died, or patient lost to follow-up) and the underlying associated factors. We conformed to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 Guidelines for this systematic review. We included adults (>19 years old) with chronic kidney disease who needed hemodialysis and had microbiologically confirmed multidrug-resistant pulmonary TB, excluding patients who had a renal allograft transplant, were on peritoneal dialysis, had extrapulmonary TB, were children and pregnant patients. We searched PubMed, MEDLINE, PubMed Central, ScienceDirect, Public Library of Science (PLOS), and Google Scholar. Keywords were combined with the Boolean "AND" operator to gather results as well as the medical subject heading (MeSH) search strategy. After screening study articles by reading their titles and abstracts, the following tools were used to assess the risk of bias: the Newcastle-Ottawa scale for observational studies, the Assessment of Multiple Systematic Reviews (AMSTAR) checklist for systematic reviews, and the Joanna Briggs Institute (JBI) assessment tool for case reports. Primary and secondary outcomes were assessed, and a conclusion was made. We gathered 21,570 studies from the databases between 2013 and 2023, with 30,062 total participants. There were eight eligible studies for review. Patients with CKD, particularly those on dialysis, are at increased risk of TB due to a combination of factors that contribute to immunosuppression. TB reactivation is common in chronic renal failure patients. Diagnostic samples such as sputum and pleural fluid had lower sensitivity rates compared to tissue samples, which led to delays in diagnosis and treatment and, most importantly, contributed to drug resistance. All new dialysis patients should undergo interferon-gamma release assay testing. TB-infected patients with severe renal disease (eGFR 30 ml/min) had increased morbidity and mortality; however, the use of directly observed treatment, short-course (DOTS), and renal-dose adjustment of anti-TB medications significantly reduced these risks. Drug-induced hepatitis and cutaneous reactions were common adverse effects of anti-TB medications. A therapeutic drug monitoring guideline is required to reduce these adverse events and even mortality. Additional research is required to assess the safety and efficacy of therapeutic regimens, as well as their outcomes, in this population with multidrug-resistant TB.
PubMed: 37123717
DOI: 10.7759/cureus.36833 -
Digestive Surgery 2016Laparoscopic sigmoidectomy for diverticulitis has initially been confined to the elective setting. However, open acute sigmoidectomy for perforated diverticulitis is... (Review)
Review
BACKGROUND
Laparoscopic sigmoidectomy for diverticulitis has initially been confined to the elective setting. However, open acute sigmoidectomy for perforated diverticulitis is associated with high morbidity rates that might be reduced after laparoscopic surgery. The aim of this systematic review was to assess the feasibility of emergency laparoscopic sigmoidectomy for perforated diverticulitis.
METHODS
We performed a systematic search of PubMed, EMBASE and CENTRAL. All studies reporting on patients with perforated diverticulitis (Hinchey III-IV) treated by laparoscopic sigmoidectomy in the acute phase were included, regardless of design.
RESULTS
We included 4 case series and one cohort study (total of 104 patients) out of 1,706 references. Hartmann's procedure (HP) was performed in 84 patients and primary anastomosis in 20. The mean operating time varied between 115 and 200 min. The conversion rate varied from 0 to 19%. The mean length of hospital stay ranged between 6 and 16 days. Surgical re-intervention was necessary in 2 patients. In 20 patients operated upon without defunctioning ileostomy, no anastomotic leakage was reported. Three patients died during the postoperative period. Stoma reversal after HP was performed in 60 out of 79 evaluable patients (76%).
CONCLUSIONS
Acute laparoscopic sigmoidectomy for the treatment of perforated diverticulitis is feasible in selected patients provided they are handled by experienced hands.
Topics: Colectomy; Colon, Sigmoid; Diverticulitis, Colonic; Emergencies; Humans; Intestinal Perforation; Laparoscopy; Peritonitis; Sigmoid Diseases; Treatment Outcome
PubMed: 26551040
DOI: 10.1159/000441150 -
BMC Nephrology Aug 2022Telehealth could potentially increase independency and autonomy of patients treated with peritoneal dialysis (PD). Moreover, it might improve clinical and economic...
BACKGROUND
Telehealth could potentially increase independency and autonomy of patients treated with peritoneal dialysis (PD). Moreover, it might improve clinical and economic outcomes. The demand for telehealth modalities accelerated significantly in the recent COVID-19 pandemic. We evaluated current literature on the impact of telehealth interventions added to PD-care on quality of life (QoL), clinical outcomes and cost-effectiveness.
METHODS
An electronic search was performed in Embase, PubMed and the Cochrane Library in order to find studies investigating associations between telehealth interventions and: i. QoL, including patient satisfaction; ii. Standardized Outcomes in Nephrology (SONG)-PD clinical outcomes: PD-related infections, mortality, cardiovascular disease and transfer to hemodialysis (HD); iii. Cost-effectiveness. Studies investigating hospitalizations and healthcare resource utilization were also included as secondary outcomes. Due to the heterogeneity of studies, a meta-analysis could not be performed.
RESULTS
Sixteen reports (N = 10,373) were included. Studies varied in terms of: sample size; design; risk of bias, telehealth-intervention and duration; follow-up time; outcomes and assessment tools. Remote patient monitoring (RPM) was the most frequently studied intervention (11 reports; N = 4982). Telehealth interventions added to PD-care, and RPM in particular, might reduce transfer to HD, hospitalization rate and length, as well as the number of in-person visits. It may also improve patient satisfaction.
CONCLUSION
There is a need for adequately powered prospective studies to determine which telehealth-modalities might confer clinical and economic benefit to the PD-community.
Topics: COVID-19; Humans; Pandemics; Peritoneal Dialysis; Prospective Studies; Quality of Life; Telemedicine
PubMed: 35999512
DOI: 10.1186/s12882-022-02869-6 -
The Cochrane Database of Systematic... Dec 2015Etrolizumab (rhuMAb beta7) is an anti-integrin that selectively targets the β7 subunits of the α4β7 and αEβ7 integrins, which are involved in the pathogenesis of... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Etrolizumab (rhuMAb beta7) is an anti-integrin that selectively targets the β7 subunits of the α4β7 and αEβ7 integrins, which are involved in the pathogenesis of ulcerative colitis.
OBJECTIVES
The objectives of this review were to assess the efficacy and safety of etrolizumab for induction of remission in ulcerative colitis.
SEARCH METHODS
We searched PubMed, MEDLINE, EMBASE, and the Cochrane Library (CENTRAL) from inception to 12 March 2015. References and conference abstracts were searched to identify additional studies.
SELECTION CRITERIA
Randomized controlled trials (RCTs) trials in which etrolizumab was compared to placebo or another active comparator in patients with active ulcerative colitis were included.
DATA COLLECTION AND ANALYSIS
Two authors independently screened studies for inclusion, assessed methodological quality and extracted data. We assessed methodological quality using the Cochrane risk of bias tool. The primary outcome was failure to induce clinical remission (as defined by the primary studies). Secondary outcomes included failure to induce clinical improvement (as defined by the primary studies), failure to induce endoscopic remission (as defined by the primary studies), adverse events, serious adverse events, withdrawal due to adverse events, and health-related quality of life (as defined by the primary studies). We assessed the overall quality of the evidence using the GRADE criteria. We calculated the risk ratio (RR) and corresponding 95% confidence interval (CI) for each dichotomous outcome.
MAIN RESULTS
Two RCTs including 172 patients with moderate to severe UC who failed conventional therapy met the inclusion criteria. Both studies were rated as low risk of bias. We did not pool efficacy data from the two included studies due to differences in dose and route of administration. The small phase I study found no statistically significant differences between etrolizumab and placebo in the proportion of patients who failed to enter remission (RR 1.04, 95% CI 1.04 to 1.69; participants = 23) or respond at week 10 (RR 1.67, 95% CI 0.26 to 10.82; participants = 23). The phase II study reported on failure to enter clinical remission at weeks 6 and 10. In the etrolizumab group 91% (71/78) of patients failed to enter remission at week 6 compared to 95% (39/41) of placebo patients (RR 0.96, 95% CI 0.87 to 1.06). Subgroup analysis revealed no statistically significant differences by dose. At week 10, there was a statistically significant difference in clinical remission rates favouring etrolizumab over placebo. Of the patients who received etrolizumab, 85% (66/78) failed to enter remission at week 10 compared to 100% (41/41) patients in the placebo group (RR 0.86, 95% CI 0.77 to 0.95). A subgroup analysis by dose found a statistically significant difference in clinical remission rates favoring 100 mg etrolizumab over placebo (RR 0.81 CI 95% 0.68 to 0.96), but not 300 mg etrolizumab over placebo (RR 0.91, 95% CI 0.80 to 1.03). No significant heterogeneity was detected for this comparison (P = 0.28, I(2) = 13.5%). GRADE analyses indicated that the overall quality of evidence for the clinical remission outcomes was moderate due to sparse data. Both of the included studies reported on safety. The outcome adverse events was initially pooled, however this analysis was removed due to high heterogeneity (I(2) = 88%). The phase I study found no statistically significant difference between etrolizumab and placebo in the proportion of patients who had at least one adverse event. Ninety-five per cent (36/38) of etrolizumab patients had at least one adverse event compared to 100% (10/10) of placebo patients (RR 0.98, 95% CI 0.84 to 1.14). Common adverse events reported in the phase I study included exacerbation of UC, headache, fatigue, abdominal pain, dizziness, nasopharyngitis, nausea, arthralgia and urinary tract infection. There was a statistically significant difference between etrolizumab and placebo in the proportion of patients who had at least one adverse event. Fifty-six per cent (44/78) of etrolizumab patients had at least one adverse event compared to 79% of placebo patients (RR 0.71, 95% CI 0.55 to 0.91). A GRADE analysis indicates that the overall quality of the evidence for this outcome was moderate due to sparse data. Common adverse events reported in the phase II study included worsening UC, nasopharyngitis, nervous system disorders, headache and arthralgia . A pooled analysis of two studies indicates that there was no statistically significant difference in the proportion of patients who had a serious adverse event. Twelve per cent (14/116) of etrolizumab patients had a serious adverse event compared to 12% of placebo patients (6/49) (RR 0.92, 95% CI 0.36 to 2.34). A GRADE analysis indicated that the overall quality of the evidence for this outcome was low due to very sparse data (20 events). Common serious adverse events included worsening of UC, impaired wound healing and bacterial peritonitis.
AUTHORS' CONCLUSIONS
Moderate quality evidence suggests that etrolizumab may be an effective induction therapy for some patients with moderate to severe ulcerative colitis who have failed conventional therapy. Due to small numbers of patients in dose subgroups the optimal dosage of etrolizumab is unclear. Due to sparse data we are uncertain regarding the risk of adverse events and serious adverse events. Further studies are needed to determine the efficacy and safety of etrolizumab in this patient population. There are five ongoing phase III etrolizumab trials and two ongoing open-label extension studies that will provide important new information on the efficacy, safety and optimal dose of this drug for the treatment of UC.
Topics: Antibodies, Monoclonal, Humanized; Colitis, Ulcerative; Humans; Induction Chemotherapy; Randomized Controlled Trials as Topic; Time Factors
PubMed: 26630451
DOI: 10.1002/14651858.CD011661.pub2