Judy Qiang

Adverse events resulting in withdrawal of biologic therapy for psoriasis in real-world clinical practice: A Canadian multicenter retrospective study

BACKGROUND Safety profiles of biologics for treatment of psoriasis are limited to data from randomized controlled trials. There is a need for comparative safety reports of biologics based on data from clinical practice. OBJECTIVE We sought to estimate and compare the incidence of adverse events (AEs) leading to withdrawal of biologics (etanercept, infliximab, adalimumab, and ustekinumab) in the treatment of psoriasis. METHODS We conducted a multicenter retrospective chart review from September 2005 to September 2014. Incidence proportion and rate of AEs leading to withdrawal by biologic agent and AE were calculated. RESULTS For 545 treatments administered in 398 patients, 22 (4.04%) AEs were associated with withdrawal, for a rate of 1.97/100 patient-years (95% confidence interval [CI] 1.32-2.94). Common AEs were injection-/infusion-site reactions (0.55%, 0.92%, 0%, and 0% for etanercept, infliximab, adalimumab, and ustekinumab, respectively); infections (0%, 0.18%, 0.55%, 0.18%); and malignancies (0.18%, 0.18%, 0%, 0.37%). LIMITATIONS Possible incompleteness of chart details and small study population limit the conclusiveness of findings. CONCLUSION Biologic agents for treatment of psoriasis are safe; AEs associated with withdrawal occurred in 4% of all administered biologic therapies. It does not appear that real-world patients encounter more AEs with biologics than patients in clinical trials.

Risk of Malignancy in Dermatomyositis and Polymyositis: A Systematic Review and Meta-Analysis

Background: There is variation in the risk of malignancy in dermatomyositis (DM) and polymyositis (PM) in the existing literature. Objective: To conduct a meta-analysis to estimate the risk of malignancy in DM and PM as compared with the general population. Methods: Medline and Embase Database abstracts were searched through August 2014 using the search terms myositis, neoplasms, and paraneoplastic syndromes. Population-based, observational studies in English were included. Meta-analyses were conducted using random-effects models. Results: A total of 5 studies with 4538 DM or PM patients were included in the analysis. The overall relative risk was 4.66 for DM and 1.75 for PM. By gender, the standardized incidence ratio (SIR) of malignancy among DM patients was 5.29 for males and 4.56 for females; the SIR of malignancy among PM patients was 1.62 for males and 2.02 for females. By time since diagnosis, the SIR of malignancy among DM patients was 17.29 in the first year, 2.7 between 1 and 5 years, and 1.37 after 5 years. By age group, the SIR among DM patients was 2.79 for patients between 15 and 44 years and 3.13 beyond 45 years. Conclusions: Both DM and PM are associated with increased risk of malignancy, but the risk is higher in DM. The risk of malignancy is present in both genders and all age groups and is highest in the first year after diagnosis but persists beyond the fifth year in DM. Adults should be evaluated for malignancy at diagnosis, followed by long-term surveillance.

Survival rates of biological therapies for psoriasis treatment in real-world clinical practice: A Canadian multicentre retrospective study

Data on biologic drug survival in real‐world psoriasis treatment are limited. There is a need to evaluate long‐term trends of biologic use outside the realm of clinical trials.

Sa1234 RNA-Seq Derived Whole Blood Gene Expression Signature As a Biomarker for Differential Diagnosis and Intestinal Inflammation in Inflammatory Bowel Disease

Introduction: In the last two decades the therapeutic paradigm of Crohns disease (CD) has changed dramatically thanks to the use of biological drugs. In this scenario, we must consider the pivotal role of tumor necrosis factor-alpha (TNF-α), a pro-inflammatory cytokine, in the pathogenesis and relapse of CD. High levels of TNF-α have been associated with the development of intestinal inflammation in CD and blocking this cytokine with anti-TNF-α molecules may result in mucosal healing. In addition several studies have shown increased TNF-α levels in the serum and in the intestinal mucosa of patients with CD. However, little is known about the course of TNF-α levels and their relationship with disease recurrence in CD patients during maintenance treatment with Adalimumab. Aim: We assessed TNF-α levels in patients with CD who were in maintenance treatment with ADA and correlated them with clinical and endoscopic disease activity. Methods: In this prospective observational cohort study, performed at a single tertiary referral center, 23 [14M/9F; mean age 41 (range 21-66) infliximab-Naive patients with CD in maintenance treatment with ADA were included and followed-up. Blood samples were drawn at standardized time points (i.e. at 6, 12, 18, 24 months and in case of CD relapse) just before ADA injection. Antibodies against ADA (AAA) were measured using an homogenous mobility shift assay (HMSA; Prometheus Lab, San Diego, United States). Blood samples were considered positive for AAA presence if ≥1.7 U/mL. Disease activity was assessed at the same points by means of the Harvey-Bradshaw Index (HBI, remission 16). Moreover, endoscopic activity was assessed at baseline and at the time of relapse by means of CD endoscopic index (CDEIS 5 responder, CDEIS<3 complete endoscopic remission and mucosal healing). Results: We have data from 133 blood samples. AAA were observed in 26/133 (19.5%) samples, and 10/26 (38.5%) had a value of AAA ≥1.7 U/mL. TNF-α levels were present in all samples assessed (Mean 4.4, range 027.2). As shown in the figure, per-patient median TNF-α levels were strongly correlated with median HBI scores (r2=0.702, p<0.0001). Moreover, TNF levels were also correlated with CDEIS (r2=0.350, p=0.001). Conclusion: TNF-α levels strongly correlated with disease activity based on HBI and CDEIS indices in patients with CD in maintenance treatment with ADA. Indeed, moderate to severe patients often have high sustained TNF-α levels.

Efficacies Of Biologic Therapies at week 12 in patients with Plaque Psoriasis in Real World Academic Clinical Practice: A Canadian Multicentre Retrospective Study.

Psoriasis is a chronic inflammatory condition for which biologic therapies have been proven as effective therapies.1 However, considerable variation in the real world efficacy of these agents is observed in clinical practice.2 Given the treatment choices available, it is vital that dermatologists have access to the necessary information for optimal treatment selection in daily clinical practice. In this large, multi-centre study, we examine the real world effectiveness of, etanercept (ETN), adalimumab (ADA), ustekinumab (UST), infliximab (IFX) and validated assessment tools of response to these treatments. This article is protected by copyright. All rights reserved.

Support systems of women with epilepsy in pregnancy: A retrospective needs assessment.

PURPOSE To explore support systems for women with epilepsy (WWE) during pregnancy. METHODS Audio-recorded, transcribed, semi-structured telephone interviews with WWE in pregnancy and following childbirth were coded using descriptive thematic analysis. RESULTS Twelve women with epilepsy aged 21-37 years who received care during pregnancy in our epilepsy clinic from 2010 to 2013 were interviewed. Women identified three areas of support: immediate family, their specialist and group support. Some women felt unable to fully share health concerns with family members, but appreciated their support. Neurologists were perceived as reliable sources of support and information, but could be inaccessible. Support groups were seen as beneficial, but may heighten womens fear of epilepsy-related adverse events during pregnancy. CONCLUSION This study highlights the use of support systems by WWE during pregnancy. The richness of the transcribed interviews provides valuable insight into the pregnancy-experience of WWE and helps to direct future clinical and research goals and hypotheses.

Effectiveness of sequential use of biologics in the treatment of moderate to severe psoriasis in real world Canadian academic clinical practice: A cohort study

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MACEs Not Associated With the Use of Biologic Therapy for Psoriasis in Real-World Clinical Practice: A Canadian Multicenter Retrospective Study.

Introduction: Previous reports have shown inconsistent findings with regard to the relationship between biologic therapy and risk for major adverse cardiovascular events (MACEs). Objectives: The aim of this study was to determine the overall rate of MACEs in a cohort of 398 patients. Methods: All patients treated with biologics for psoriasis at 2 academic centers in Toronto, Ontario, between September 2005 and September 2014 were considered for inclusion. Medical records were reviewed to identify MACEs. Results: A total of 398 patients were included. The median duration of disease was 19.8 years. Median time to biologic therapy withdrawal because of an adverse event was 23.5 months. In this cohort, no MACEs were identified in patients treated with biologic therapy. Conclusions: Biologic treatment for psoriasis was not associated with increased cardiovascular risk in this cohort. These results require validation in larger studies.