scholarly journals Comparable Rates of Glucocorticoid-Associated Adverse Events in Patients With Polymyalgia Rheumatica and Comorbidities in the General Population

2018 ◽  
Vol 70 (4) ◽  
pp. 643-647 ◽  
Author(s):  
Izzat Shbeeb ◽  
Divya Challah ◽  
Shafay Raheel ◽  
Cynthia S. Crowson ◽  
Eric L. Matteson
Keyword(s):  
General Population ◽  
Adverse Events ◽  
Polymyalgia Rheumatica

Treatment of attention deficit/hyperactivity disorder in children with CHD

2021 ◽  
pp. 1-4
Author(s):  
Alyson R. Pierick ◽  
Melodie Lynn ◽  
Courtney M. McCracken ◽  
Matthew E. Oster ◽  
Glen J. Iannucci
Keyword(s):  
Attention Deficit Hyperactivity Disorder ◽  
General Population ◽  
Adverse Events ◽  
Supraventricular Tachycardia ◽  
Medical Therapy ◽  
Attention Deficit ◽  
Case Reports ◽  
Single Centre ◽  
Hyperactivity Disorder ◽  
Increased Risk

Abstract Introduction: The prevalence of attention deficit/hyperactivity disorder in the general population is common and is now diagnosed in 4%–12% of children. Children with CHD have been shown to be at increased risk for attention deficit/hyperactivity disorder. Case reports have led to concern regarding the use of attention deficit/hyperactivity disorder medications in children with underlying CHD. We hypothesised that medical therapy for patients with CHD and attention deficit/hyperactivity disorder is safe. Methods: A single-centre, retrospective chart review was performed evaluating for adverse events in patients aged 4–21 years with CHD who received attention deficit/hyperactivity disorder therapy over a 5-year span. Inclusion criteria were a diagnosis of CHD and concomitant medical therapy with amphetamines, methylphenidate, or atomoxetine. Patients with trivial or spontaneously resolved CHD were excluded from analysis. Results: In 831 patients with CHD who received stimulants with a mean age of 12.9 years, there was only one adverse cardiovascular event identified. Using sensitivity analysis, our median follow-up time was 686 days and a prevalence rate of 0.21% of adverse events. This episode consisted of increased frequency of supraventricular tachycardia in a patient who had this condition prior to initiation of medical therapy; the condition improved with discontinuation of attention deficit/hyperactivity disorder therapy. Conclusion: The incidence of significant adverse cardiovascular events in our population was similar to the prevalence of supraventricular tachycardia in the general population. Our single-centre experience demonstrated no increased risk in adverse events related to medical therapy for children with attention deficit/hyperactivity disorder and underlying CHD. Further population-based studies are indicated to validate these findings.

Real-life use of nivolumab and pembrolizumab in four adult university teaching hospitals in Québec, Canada.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e14125-e14125 ◽  
Author(s):  
Nathalie Letarte ◽  
Layal El Raichani ◽  
Chantal Guevremont ◽  
Nathalie Marcotte ◽  
Ghislain Berard ◽  
...  
Keyword(s):  
General Population ◽  
Adverse Events ◽  
Real Life ◽  
Median Number ◽  
University Teaching ◽  
Teaching Hospitals ◽  
Grade 3 ◽  
Nsclc Patients ◽  
University Teaching Hospitals

e14125 Background: Nivolumab and pembrolizumab, two anti-PD1 agents, were approved and funded in Québec since 2016 for non small cell lung cancer (NSCLC), renal cell carcinoma (RCC) and melanoma. The objectives were to describe and assess the “real-life” use, efficacy and security of nivolumab and pembrolizumab in NSCLC, RCC and melanoma in the general population. Methods: Medical records of every patient who received nivolumab or pembrolizumab between January 1st 2011 and October 31st 2017 were reviewed retrospectively. Data analysis cut-off was Dec 31st 2017. Results: In total, 532 patients received at least one dose of anti-PD1 during the study period. Median number of doses received varied for each indication (medians varied from 4 to 9.5). Adverse events were pooled together by drug. 47.7 % of patients receiving pembrolizumab suffered from any grade immune-related adverse event (IRAE), most of them of grade 1 or 2. 12.2 % of patients reported grade 3-4 IRAE. Most of the patients reported only one type of IRAE. For nivolumab, 44.6% of patients presented with any IRAE, including 8.3% of grade 3-4. Dermatologic IRAE were more frequent in the melanoma patients whereas gastrointestinal and pulmonary IRAE were more frequent in NSCLC patients. Treatment discontinuation due to adverse events varied from 6 to18% depending on indication. Conclusions: Nivolumab and pembrolizumab seemed less effective and caused more IRAE in “real-life” population than in the pivotal clinical trials. Caution and regular follow-up are warranted when using these drugs in general population. Longer follow-up is needed.[Table: see text]

scholarly journals Adverse events associated with treatment of latent tuberculosis in the general population

2011 ◽  
Vol 183 (3) ◽  
pp. E173-E179 ◽  
Author(s):  
B. M. Smith ◽  
K. Schwartzman ◽  
G. Bartlett ◽  
D. Menzies
Keyword(s):  
General Population ◽  
Adverse Events ◽  
Latent Tuberculosis

Abatacept as Adjunctive Therapy in Refractory Polymyalgia Rheumatica

2021 ◽  
pp. jrheum.210455
Author(s):  
Eric Toussirot ◽  
Martin Michaud ◽  
Daniel Wendling ◽  
Valérie Devauchelle
Keyword(s):  
Adverse Events ◽  
Polymyalgia Rheumatica ◽  
Adjunctive Therapy ◽  
Substantial Proportion

Glucocorticoids (GCs) are the mainstay of treatment for patients with polymyalgia rheumatica (PMR).1 Despite their efficacy, GCs are associated with well-known adverse events and a substantial proportion of patients with PMR do not respond adequately, or are refractory, to initial GC treatment. GC-sparing agents in PMR are limited to methotrexate (MTX).1

A Close Association of History of Autoimmunity with Chronic Myelomonocytic Leukemia (CMML) in Contrast to Chronic Myelogenous Leukemia (CML)

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 1712-1712 ◽  
Author(s):  
Deniz Peker ◽  
Eric Padron ◽  
Pedro Horna ◽  
John M. Bennett ◽  
Xiaohui Zhang ◽  
...  
Keyword(s):  
General Population ◽  
Autoimmune Diseases ◽  
Medical History ◽  
Polymyalgia Rheumatica ◽  
Chronic Myelomonocytic Leukemia ◽  
Myelogenous Leukemia ◽  
Cancer Center ◽  
Past Medical History ◽  
History Of ◽  
Myelomonocytic Leukemia

Abstract Abstract 1712 Background: Chronic myelomonocytic leukemia (CMML) is a myelodysplastic and myeloproliferative neoplasm (MDS/MPN) characterized by cytopenias, persistent monocytosis, morphologic dysplasia and a tendency to transform to acute myeloid leukemia (AML). Similar to MDS, multiple genetic, molecular, microenvironmental and immunologic mechanisms of pathogenesis have been linked to CMML. Autoimmunity results from inflammation and tissue damage caused by inappropriate T and B cell self-recognition. The prevalence of autoimmunity in the U.S. population (not age adjusted) was estimated to be 3.2% prior to 1996 and is now 5 –8% according to 2004 data with a female prevalence (M: F= 1:3) (http://www.niaid.nih.gov/topics/autoimmune/documents/adccfinal.pdf). The prevalence of autoimmunity is estimated to be higher (10–17%) in MDS and MDS derived AML compared to the general population (Giannouli S et al.2012, Emadi A abstract 2012 ASCO). Recent investigations have shown a close link between autoimmune disorders and cancer. A recent study indicated that a history of autoimmununity might predict a better clinical response to DNA methyltransferase inhibitors (DNMTI) in MDS [Emadi A abstract 2012 ASCO]. The current study was conducted to identify the prevalence of autoimmune diseases in patients with CMML and compare it with the general population and to patients with a non-MDS-related MPN chronic myelogenous leukemia (CML). Methods: A retrospective analysis was performed of a series of 123 patients with CMML at Moffitt Cancer Center diagnosed between January 1999 and June 2011. A consecutive collection of 116 patients who were diagnosed with CML between January 2007 and June 2011 was included for comparison. Patients with a past medical history of autoimmunue disorders e.g. idiopathic thrombocytopenic purpura (ITP), Sjogren's syndrome, rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), multiple sclerosis (MS), chronic autoimmune hemolytic anemia, inflammatory bowel diseases (IBD, ulcerative colitis or Crohn disease), psoriasis etc. were retrieved and clinical findings were correlated to published prevalence of these conditions in the general population. Results: Among 123 CMML patients (average age of 68.6, ranging from 30 to 90 y/o, M: F = 2.61), 20 (16.26%, 8 Female, 12 Male) had a history of autoimmune related disorders: RA(3, 2.4%), MS (2, 1.6% ), Sjogren's syndrome (1, 0.8%), IBD(1, 0.8%), autoimmune anemia (1, 0.8%), psoriasis (4, 3.25%), polymyalgia rheumatica (1, 0.8%), ITP(6, 4.9%), hyperthyroidism (2, 1.6%); and 3 patients have more than 1 autoimmune disorder. In addition, 9 of 123 cases (7.3%) had a history of the other malignancies (7 with solid tumors and 2 with hematopoietic neoplasms other than MDS/CMML/AML, but no CML). In the CML group (average age of 55.5, ranging from 21 to 84 y/o, M: F = 1.2), history of autoimmunity was found in 6 of 116 patients (5.2%), which is similar to reports of these conditions in the general population. The autoimmune phenomenon included 2 RA, 2 polymyalgia rheumatica, 1 IBD, and 1 psoriasis. There was a statistically significant difference in the rate of autoimmune diseases between CMML and CML (p=0.0066, X2test). Of note, 5 CMML patients were considered secondary CMML; however, none of the 5 patients in the study had documented autoimmununity in his/her past medical history. Conclusion: The presence of autoimmune disorders is significantly higher in CMML compared to historical data on the general population and Moffitt Cancer Center patients with CML. Identifying autoimmune process in CMML may relevance to development of novel therapeutic strategies. A larger study to explore the detailed relationship between a history of autoimmune diseases and CMML is needed to define the molecular pathogenesis. Disclosures: No relevant conflicts of interest to declare.

scholarly journals OP0270 TRHEUMA REGISTRY EXPLORES CHARACTERISTICS AND SUITABLE DIAGNOSTIC AND THERAPEUTIC MANAGEMENT OF RHEUMATIC IMMUNE-RELATED ADVERSE EVENTS (IRAES)

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 168.1-169
Author(s):  
K. Benesova ◽  
L. Diekmann ◽  
H. M. Lorenz ◽  
K. Jordan ◽  
J. Leipe
Keyword(s):  
Adverse Events ◽  
Polymyalgia Rheumatica ◽  
Tumor Response ◽  
Symptom Control ◽  
University Hospital ◽  
Therapeutic Management ◽  
Future Research ◽  
Research Support ◽  
Scientific Support ◽  
Organ Systems

Background:Reports of rheumatic immune-related adverse events (irAEs) in patients receiving immune checkpoint inhibitors (ICPi) have recently attracted new attention to the complex interrelations of malignancies andrheumatic and musculoskeletal diseases (RMDs). Since those two entities represent two sides of a dysregulated immune response, further research on rheumatic irAEs and mechanisms underlying the better tumor response rates in irAE-affected patients may contribute to a better understanding of the different pathophysiology characterizing tumor and rheumatic disease.Objectives:Given the heterogeneity of the patient population with rheumatic irAEs, a registry-based study has been conducted to provide first evidence regarding characteristics of rheumatic irAEs and further insights into the optimal diagnostic and therapeutic management of rheumatic irAEs.Methods:The TRheuMa registry is a long-term, open-end observational study of a patient cohort suffering from rheumatic symptoms as a result of ICPi or other cancer therapies. The TRheuMa registry is one of the three subregistries of the MalheuR project, a registry-based study initiated in July 2018 at the at the university hospital Heidelberg to explore interrelations of malignancies and RMDs.Results:Over 18 months, 52 of 63 patients in the TRheuMa registry were recruited with a rheumatic irAE under ICPi treatment (pembrolizumab n=21, nivolumab n=28, ipilimumab n=11, durvalumab n=1, atezolizumab n=2, avelumab n=1, history of >1 ICPi n=11). Of the 52 patients, 22 (42.3%) had non-small cell lung cancer and 23 (44.2%) had a melanoma. Eight (15.3%) patients experienced a flare of a preexisting RMD under ICPi treatment. The remaining 44 patients withde novoirAEs were characterized by rheumatoid arthritis-like (20.5%) or polymyalgia rheumatica-like (18.1%) and psoriatic or other spondyloarthritis-like phenotypes (50.0%). However, laboratory findings differed from classical RMDs with elevated CRP-levels in 73.1% particularly in psoriatic arthritis-like, but not necessarily in polymyalgia rheumatica-like irAEs. On the contrary, autoantibody positivity was very rare. The majority of patients (78.8%) showed signs of inflammation upon ultrasound examination.Based on the severity of signs and symptoms as well as treatment response, we developed a therapeutic algorithm for rheumatic irAEs: non-steroidal anti-inflammatory drugs and/or low dosed glucocorticoids (≤10mg prednisone equivalent) as first treatment step were sufficient for 75% patients, whereas 17.3% required higher dosed glucocorticoids and 11.5% patients required further treatment with a cs- or bDMARD. In two cases ICPi-treatment was discontinued on patients’ request due to the pain and functional impairment caused by the rheumatic irAE, although a satisfactory symptom control was reached in the further course.Complete remission of cancer was observed in 43.5% of melanoma patients, 66.7% experienced additional severe irAEs in other organ systems.Conclusion:Overall, data from the TRheuMa-registry show that rheumatic irAEs mostly resemble classical RMDs, however show distinct characteristics. Our diagnostic and therapeutic management of rheumatic irAEs demonstrated efficacy in the majority of patients. These findings contribute to the further understanding of rheumatic irAEs and malignancies. Future research agenda includes a correlation of irAE severity with tumor response.Disclosure of Interests:Karolina Benesova Grant/research support from: Study grants for SCREENED study by Abbvie, Novartis and Rheumaliga Baden-Württemberg, Consultant of: One-time participation in Novartis advisory board., Leonore Diekmann: None declared, Hanns-Martin Lorenz Grant/research support from: Consultancy and/or speaker fees and/or travel reimbursements: Abbvie, MSD, BMS, Pfizer, Celgene, Medac, GSK, Roche, Chugai, Novartis, UCB, Janssen-Cilag, Astra-Zeneca, Lilly. Scientific support and/or educational seminars and/or clinical studies: Abbvie, MSD, BMS, Pfizer, Celgene, Medac, GSK, Roche, Chugai, Novartis, UCB, Janssen-Cilag, Astra-Zeneca, Lilly, Baxter, SOBI, Biogen, Actelion, Bayer Vital, Shire, Octapharm, Sanofi, Hexal, Mundipharm, Thermo Fisher., Consultant of: see above, Karin Jordan Consultant of: Consultancy and/or speaker fees: MSD, Merck, Amgen, Hexal, Riemser, Helsinn, Tesaro, Kreussler, Voluntis, Pfizer, Pomme-med., Jan Leipe Grant/research support from: Consultancy and speaker fees: Abbvie, AstraZeneca, BMS, Celgene, Hospira, Janssen-Cilag, LEO Pharma, Lilly, MSD, Novartis, Pfizer, Roche, Sanofi, UCB. Scientific support: Novartis, Pfizer., Consultant of: Consultancy and speaker fees: Abbvie, AstraZeneca, BMS, Celgene, Hospira, Janssen-Cilag, LEO Pharma, Lilly, MSD, Novartis, Pfizer, Roche, Sanofi, UCB. Scientific support: Novartis, Pfizer., Speakers bureau: Abbvie, AstraZeneca, BMS, Celgene, Hospira, Janssen-Cilag, LEO Pharma, Lilly, MSD, Novartis, Pfizer, Roche, Sanofi, UCB

scholarly journals FRI0475 STEROID SPARING AGENTS IN POLYMYALGIA RHEUMATICA: A SYSTEMATIC REVIEW

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 834.2-835
Author(s):  
S. Banerjee ◽  
K. Chaudhuri ◽  
A. Desai ◽  
M. Krishna ◽  
N. Gullick
Keyword(s):  
Adverse Events ◽  
Polymyalgia Rheumatica ◽  
Classification Criteria ◽  
Risk Of Bias ◽  
List Type ◽  
High Quality ◽  
Level 1 ◽  
Sparing Effect ◽  
Level 2 ◽  
Steroid Sparing

Background:Polymyalgia rheumatica (PMR) is the commonest chronic inflammatory musculoskeletal disease of the elderly. The mainstay of treatment for PMR is long term systemic glucocorticoid (GC), which is associated with significant systemic toxicity. There is a need for steroid sparing drugs in PMR to reduce GC cumulative dose and GC induced adverse effects.(1)Objectives:To evaluate the role of steroid sparing agents in PMR.Primary outcomes:1.Steroid sparing effect of the intervention, measured by difference in cumulative glucocorticoid dose2.Percentage of patients in remission.Secondary outcomes:1. Mean reduction of CRP/ESR2. Adverse event/toxicity the drugs being compared—measured as number of patients with adverse events in the compared groups3. Percentage of patients with relapse during study period4. MortalityMethods:Electronic databases including Medline, Embase and Cochrane databases (CENTRAL) were searched since inception for prospective randomized control trials comparing disease modifying anti rheumatic drugs (DMARDs) and biologics with systemic GC in PMR, published in English with more than 20 patients and a minimum study duration of 24 weeks. As different classification criteria for PMR exist, studies were included if they used any accepted classification criteria for PMR. Case series, case reports, retrospective, non-randomized trials, abstracts, systematic reviews and non English language trials were not included. Patients with Giant cell arteritis (GCA) were excluded. Risk of bias and quality was assessed using the Cochrane tool.The studies were assessed for cumulative GC dose, proportion of patients in remission, proportion of patients with relapse, reduction in inflammatory markers, adverse events and mortality.Results:5 studies were selected for final review-- 3 studies involving Methotrexate, one study on azathioprine, one on Infliximab. The study on Azathioprine had high risk of bias, small sample size and low quality (Level 2 evidence) with high attrition rate but it revealed reduction of daily prednisolone with Azathioprine. A high quality RCT (Level 1) did not confirm a steroid sparing effect with Infliximab vs placebo, and there was no significant difference between relapse or remission rate. Methotrexate studies showed conflicting results: one high quality RCT (Level 1) and one low quality RCT (Level 2) on Methotrexate revealed statistically significant steroid sparing effect, however the remaining study did not demonstrate between Methotrexate and placebo. Two methotrexate studies assessed the risk of relapse, with conflicting results (relapses 73% placebo vs 47% methotrexate; or no difference).Methotrexate was not associated with increased adverse effects in any of the studies. Azathioprine was associated with significant adverse events resulting in high attrition.A meta analysis was not performed for methotrexate as the studies were heterogenous.Conclusion:There is a lack of evidence regarding DMARDs and biologics in PMR. Methotrexate is an effective steroid sparing agent, and is not associated with increased adverse events. Azathioprine may be effective but is associated with significant adverse events. Infliximab is not an effective steroid sparing agent in PMR. More high quality RCTs are needed to study the efficacy of steroid sparing agents.References:[1]Bhaskar Dasgupta, Frances A. Borg, Nada Hassan, Kevin Barraclough, Brian Bourke, Joan Fulcher, Jane Hollywood, Andrew Hutchings, Valerie Kyle, Jennifer Nott, Michael Power, Ash Samanta, on behalf of the BSR and BHPR Standards, Guidelines and Audit Working Group, BSR and BHPR guidelines for the management of polymyalgia rheumatica,Rheumatology, Volume 49, Issue 1, January 2010, Pages 186–190Disclosure of Interests:None declared

Adverse Events During Longterm Low-dose Glucocorticoid Treatment of Polymyalgia Rheumatica: A Retrospective Study

2012 ◽  
Vol 39 (3) ◽  
pp. 552-557 ◽  
Author(s):  
MAURIZIO MAZZANTINI ◽  
CLAUDIA TORRE ◽  
MARIO MICCOLI ◽  
ANGELO BAGGIANI ◽  
ROSARIA TALARICO ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Acute Myocardial Infarction ◽  
Retrospective Study ◽  
Adverse Events ◽  
Arterial Hypertension ◽  
Cumulative Dose ◽  
Polymyalgia Rheumatica ◽  
Low Dose ◽  
Univariate Analysis ◽  
Fragility Fractures

Objective.To assess the occurrence of adverse events in a cohort of patients with polymyalgia rheumatica (PMR), treated with low-dose glucocorticoids (GC).Methods.This was a retrospective study by review of medical records.Results.We identified 222 patients who had a mean duration of followup of 60 ± 22 months and a mean duration of GC therapy of 46 ± 22 months. We found that 95 patients (43%) had at least 1 adverse event after a mean duration of GC therapy of 31 ± 22 months and a mean cumulative dose of 3.4 ± 2.4 g. In particular, 55 developed osteoporosis, 31 had fragility fractures; 27 developed arterial hypertension; 11 diabetes mellitus; 9 acute myocardial infarction; 3 stroke; and 2 peripheral arterial disease. Univariate analysis showed that the duration of GC treatment was significantly associated with osteoporosis (p < 0.0001), fragility fractures (p < 0.0001), arterial hypertension (p < 0.005), and acute myocardial infarction (p < 0.05). Cumulative GC dose was significantly associated with osteoporosis (p < 0.0001), fragility fractures (p < 0.0001), and arterial hypertension (p < 0.01). The adverse events occurred more frequently after 2 years of treatment. Multivariate analysis showed that GC duration was significantly associated with osteoporosis (adjusted OR 1.02, 95% CI 1.02–1.05) and arterial hypertension (adjusted OR 1.03, 95% CI 1.01–1.06); GC cumulative dose was significantly associated with fragility fractures (adjusted OR 1.4, 95% CI 1.03–1.8).Conclusion.Longterm, low-dose GC treatment of PMR is associated with serious adverse events such as osteoporosis, fractures, and arterial hypertension; these adverse events occur mostly after 2 years of treatment.

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