scholarly journals A Broad Safety Assessment of the 9-Valent Human Papillomavirus Vaccine

2021 ◽  
Author(s):  
W Katherine Yih ◽  
Martin Kulldorff ◽  
Inna Dashevsky ◽  
Judith C Maro
Keyword(s):  
Human Papillomavirus ◽  
Adverse Events ◽  
Multiple Testing ◽  
Statistical Power ◽  
Hpv Vaccination ◽  
Exposure Period ◽  
Human Papillomavirus Vaccine ◽  
Serious Adverse Events ◽  
Increased Risk

Abstract Surveys of parents indicate safety is their top concern about human papillomavirus (HPV) vaccination. A data-mining method not requiring pre-specification of health outcome(s) of interest or post-exposure period(s) of potentially increased risk can check for associations between an exposure and any of thousands of medically attended health outcomes. The method was applied to the 9-valent HPV vaccine (HPV9) to detect potential safety problems. Data on 9-26-year-olds who had received HPV9 vaccine between November 4, 2016 and August 5, 2018, inclusive, were extracted from Marketscan and analyzed for statistically significant clustering of incident diagnoses within the hierarchy of ICD-10-CM coded diagnoses and temporally within the 1 year after vaccination, using the self-controlled tree-temporal scan statistic and TreeScan software. Only 56 days of post-vaccination enrollment was required; subsequent follow-up was censored at disenrollment. Multiple testing was adjusted for. The analysis included 493,089 doses of HPV9. Almost all signals resulted from temporal confounding, not unexpected with a 1-year follow-up period. The only plausible signals were for non-specific adverse events (e.g., injection-site reactions and headache) on Days 1-2 after vaccination, with attributable risks as low as 1 per 100,000 vaccinees. Considering the broad scope of the evaluation and the high statistical power, the findings of no specific serious adverse events should provide reassurance about this vaccine’s safety.

scholarly journals Immunogenicity of a Two-Dose Human Papillomavirus Vaccine Schedule in HIV-Infected Adolescents with Immune Reconstitution

Vaccines ◽  
2022 ◽  
Vol 10 (1) ◽  
pp. 118
Author(s):  
Supattra Rungmaitree ◽  
Charin Thepthai ◽  
Zheng Quan Toh ◽  
Noppasit Musiwiraphat ◽  
Alan Maleesatharn ◽  
...  
Keyword(s):  
Human Papillomavirus ◽  
Immune Reconstitution ◽  
Geometric Mean ◽  
Hpv Vaccination ◽  
Human Papillomavirus Vaccine ◽  
Hpv 16 ◽  
Cell Counts ◽  
Increased Risk ◽  
2D And 3D ◽  
Hpv 18

HIV-infected patients are at increased risk of human papillomavirus (HPV) acquisition and HPV-associated diseases. This study set out to determine whether a two-dose (2D) HPV vaccination schedule was sufficient in HIV-infected adolescents with immune reconstitution (IR) following antiretroviral treatment. Participants aged 9–15 years who had CD4 cell counts > 500 cells/mm3 and HIV-1 RNA < 40 copies/mL for at least one year were assigned to the 2D schedule, while older participants or those without IR received a three-dose (3D) schedule. Antibodies to HPV-16 and -18 were measured using a pseudovirion-based neutralization assay. A total of 96 subjects were enrolled; 31.3% and 68.7% received the 2D and 3D schedule, respectively. Of these, 66.7% and 57.6% of the 2D and 3D participants, respectively, were male. The seroconversion rates for HPV-16 and HPV-18 were 100% in all cases, except for HPV-18 in males who received the 3D schedule (97.4%). In males, the anti-HPV-16 geometric mean titers (GMTs) were 6859.3 (95% confidence interval, 4394.3–10,707.1) and 7011.1 (4648.8–10,573.9) in the 2D and 3D groups (p = 0.946), respectively, and the anti-HPV-18 GMTs were 2039.3 (1432.2–2903.8) and 2859.8 (1810.0–4518.4) in the 2D and 3D (p = 0.313) groups, respectively. In females, the anti-HPV-16 GMTs were 15,758.7 (8868.0–28,003.4) and 26,241.6 (16,972.7–40,572.3) in the 2D and 3D groups (p = 0.197), respectively, and the anti-HPV-18 GMTs were 5971.4 (3026.8–11,780.6) and 9993.1 (5950.8–16,781.1) in the 2D and 3D groups (p = 0.271), respectively. In summary, a 2D schedule is as immunogenic in young adolescents with IR as a 3D schedule in older subjects and those without IR.

scholarly journals Acceptability of the Human Papillomavirus Vaccine Among Urban Adolescent Males

2012 ◽  
Vol 7 (1) ◽  
pp. 27-36 ◽  
Author(s):  
Baudelio Gutierrez ◽  
Anthony Leung ◽  
Kevin Trimell Jones ◽  
Peter Smith ◽  
Randee Silverman ◽  
...  
Keyword(s):  
Human Papillomavirus ◽  
Hpv Vaccine ◽  
Hpv Vaccination ◽  
Hpv Infection ◽  
Adolescent And Young Adult ◽  
Human Papillomavirus Vaccine ◽  
Adult Males ◽  
Urban Adolescent ◽  
Increased Risk ◽  
Sex With Men

The human papillomavirus (HPV) vaccine was recently approved for use in males. Certain groups, such as men who have sex with men (MSM), are at increased risk of HPV infection. The purpose of the study was to understand perceptions of HPV and the vaccine among adolescent and young adult males, both heterosexual and MSM. Seventy-six males (45 heterosexual, 31 MSM) completed a questionnaire and participated in a focus group. Overall, 42% had heard of HPV and 39% had heard of the HPV vaccine. Males had moderate to favorable attitudes toward vaccination, although intentions to vaccinate were more neutral. MSM were more knowledgeable, aware, and in control of the decision to vaccinate than heterosexual males. Increasing awareness and knowledge about HPV and the vaccine may be necessary to encourage vaccination; certain subgroups of males may be more receptive to HPV vaccination than others.

scholarly journals Adverse events following school-based vaccination of girls with quadrivalent human papillomavirus vaccine in Slovenia, 2009 to 2013

2016 ◽  
Vol 21 (14) ◽  
Author(s):  
Maja Šubelj ◽  
Veronika Učakar ◽  
Alenka Kraigher ◽  
Irena Klavs
Keyword(s):  
Human Papillomavirus ◽  
Adverse Events ◽  
Vaccination Programme ◽  
Hpv Vaccination ◽  
Monitoring And Evaluation ◽  
Human Papillomavirus Vaccine ◽  
School Based ◽  
Annual Reporting ◽  
Reporting Rates ◽  
Papillomavirus Vaccine

Adverse events following immunisation (AEFIs) with qHPV reported to the Slovenian AEFI Registry for the first four school years of the vaccination programme were analysed. We calculated annual reporting rates for 11–14 year-old vaccinees with AEFIs, using the number of qHPV doses distributed within the school-based vaccination programme as the denominator. Between September 2009 and August 2013, 211 AEFIs that occurred in 89 vaccinees were reported, a rate of 149.5 vaccinees with AEFI per 100,000 qHPV doses distributed. For five vaccinees, serious AEFIs (8.4 per 100,000 doses distributed) were reported. The highest reporting rates were for fatigue, headache, and fever (≥ 38.0⁰) (53.8, 40.3, and 35.3 per 100,000 qHPV doses distributed, respectively). As no AEFI resulted in permanent sequelae and they all were categorised as serious only due to the criterion of a minimum of one day of hospitalisation, this provides reassurance for the safety of our school-based HPV vaccination programme. Further AEFI surveillance is warranted to provide data for HPV vaccination programme monitoring and evaluation of its safety.

scholarly journals Immunogenicity And Safety Of The Nine-Valent Human Papillomavirus Vaccine In Solid Organ Transplant Recipients And Hiv-Infected Adults

2020 ◽  
Author(s):  
Lise Boey ◽  
Ans Curinckx ◽  
Mathieu Roelants ◽  
Inge Derdelinckx ◽  
Eric Van Wijngaerden ◽  
...  
Keyword(s):  
Human Papillomavirus ◽  
Adverse Events ◽  
Geometric Mean ◽  
Organ Transplant ◽  
Solid Organ Transplant ◽  
Phase Iii ◽  
Solid Organ ◽  
Human Papillomavirus Vaccine ◽  
Serious Adverse Events ◽  
Hpv Types

Abstract Background The burden of human papillomavirus (HPV) in HIV-infected persons and solid organ transplant (SOT) recipients is high. Clinical trials on HPV vaccines in HIV-infected persons and particularly in SOT recipients have been sparse to date, included low numbers of participants and none of them assessed the nine-valent HPV (9vHPV). We investigated the immunogenicity with respect to HPV types 6/11/16/18/31/33/45/52/58 and the safety of the 9vHPV vaccine in HIV-infected persons and recipients of a kidney, lung or heart transplant. Methods This is a phase III investigator-initiated study in 100 HIV-infected persons (age: 18-45 years) and 171 SOT recipients (age: 18-55 years). The 9vHPV vaccine was administered at day 1, month 2 and month 6. Primary outcome was seroconversion rates to the 9vHPV types at month 7. Secondary outcomes were geometric mean titers (GMTs) and frequency of adverse events (AEs). Results All HIV-infected participants seroconverted for all HPV types, but seroconversion ranged from 46% for HPV45 to 72% for HPV58 in SOT recipients. GMTs ranged from 180 to 2985 mMU/ml in HIV-positive participants and from 17 to 170 mMU/ml in SOT recipients, depending on the HPV type. Injection-site AEs occurred in 62% of participants but were mostly mild or moderate in intensity. None of the reported serious adverse events were deemed vaccine-related. No patients died during the study. Conclusion Immunogenicity of the 9vHPV vaccine is high in HIV-infected persons but suboptimal in SOT recipients. The vaccine is safe and well tolerated in both groups.

scholarly journals Safety and Immunogenicity of the Quadrivalent Human Papillomavirus Vaccine in Patients with Juvenile Dermatomyositis: A Real-World Multicentre Study

2020 ◽  
Author(s):  
Natalia Balera Ferreira Pinto ◽  
Ingrid Herta Rotstein Grein ◽  
Aline Lobo ◽  
Noortje Groot ◽  
Flavio Sztajnbok ◽  
...  
Keyword(s):  
Human Papillomavirus ◽  
Adverse Events ◽  
Disease Activity ◽  
Hpv Vaccine ◽  
Juvenile Dermatomyositis ◽  
Hpv Vaccination ◽  
Dose Schedule ◽  
Control Group ◽  
Human Papillomavirus Vaccine ◽  
One Year

Abstract Background: Concerns about the safety and efficacy of vaccinations in patients with pediatric rheumatic diseases, such as juvenile dermatomyositis, have led to contradictions and low vaccination coverage in this group, who are at a higher risk of infections, including by human papillomavirus (HPV). Although HPV vaccine should be recommended for all juvenile dermatomyositis patients, there is a lack of data to support the safety of this vaccine. The aim of this study was to assess the safety and immunogenicity of the quadrivalent HPV vaccination in juvenile dermatomyositis patients.Methods: Juvenile dermatomyositis patients aged from 9-20 years and healthy controls were enrolled to receive a 3-dose schedule of quadrivalent HPV vaccination from March/2014 until March/2016. Study visits were performed before the first dose, one month after the second and third doses and one year after the first dose. Participants completed a diary of possible adverse events following each dose, and disease activity was measured. At each visit, serum samples was collected for testing antibody concentrations. Participants recruitment was conducted in ten Brazilian centers. From 48 eligible patients, 42 completed the 3 doses schedule of the vaccine (5 patients had received doses previously). The McNemar test and the Kappa concordance coefficient were applied to compare the disease activity scores used for juvenile dermatomyositis patients between quadrivalent HPV vaccine doses and before the vaccination. The software used was SAS 9.4.Results: No severe adverse events were related to the vaccination. The disease activity scores were usually low, and remained stable, or even improved during the follow-up. After three vaccine doses the juvenile dermatomyositis group presented seropositivity of 100% for HPV16 and 97% for HPV18, similarly to the control group who presented 100% for both. One year after the first dose the seropositivity for the patients group was 94% for both HPV types.Conclusions: The HPV vaccination in juvenile dermatomyositis patients is safe and immunogenic. Since the seropositivity against HPV16 and HPV18 was very high after the 3-dose schedule, this regimen should be recommended for juvenile dermatomyositis patients.

scholarly journals O06 Baseline predictors of methotrexate-related adverse events in methotrexate-naïve patients with RA

Rheumatology ◽  
2021 ◽  
Vol 60 (Supplement_1) ◽  
Author(s):  
Ahmad A Sherbini ◽  
James M Gwinnutt ◽  
Kimme L Hyrich ◽  
Suzanne M M Verstappen ◽  
Keyword(s):  
Rheumatoid Arthritis ◽  
Adverse Events ◽  
Health Assessment ◽  
Prevalence Rates ◽  
Clinical Predictors ◽  
Research Support ◽  
Related Data ◽  
Increased Risk ◽  
One Year

Abstract Background/Aims  Methotrexate (MTX) is the most common treatment for rheumatoid arthritis (RA). The prevalence of adverse events (AEs) associated with MTX treatment for RA have been studied extensively, but there are limited data on the predictors of these AEs. This study aims to summarise the prevalence rates of MTX AEs, including gastrointestinal (GI), neurological, mucocutaneous, and elevated alanine transaminase (ALT) enzyme, and to identify baseline demographic and clinical predictors of these AEs. Methods  The Rheumatoid Arthritis Medication Study (RAMS) is a UK multi-centre prospective cohort study of patients with RA starting MTX for the first time. Relevant demographic, medication, clinical and disease related data were collected at baseline. AEs were reported at six and twelve months follow-ups. The prevalence rates of AEs were calculated based on the proportions of patients who reported having had an AE within one year of follow-up. The associations between candidate baseline predictors and AEs were assessed using multivariable logistic regression. Results  A total of 2,089 patients were included with a mean age of 58.4 (standard deviation: 13.5) years, 1390 (66.5%) were women. 1,814 and 1,579 patients completed the 6 and 12 months follow-up visits, respectively. The prevalence rates of the AEs within one year of follow-up were: GI = 777 (40.6%), mucocutaneous = 441 (23.1%), neurological = 487 (25.5%), elevated ALT (&gt; upper limit of normal [ULN]) = 286 (15.5%). Younger age and being a woman were associated with increased risk of GI AEs, (age: OR 0.97 per year increase in age, 95% CI 0.98, 1.00; male sex: OR 0.58 vs female, 95% CI 0.46, 0.74) (Table 1). Higher baseline Health Assessment Questionnaire (HAQ) score was an independent predictor of GI, mucocutaneous, and neurological AEs. Furthermore, having ALT &gt;1xULN at baseline or history of diabetes was associated with increased risk of subsequent ALT elevation during the study follow-up. Conclusion  In patients with RA starting MTX, GI AEs were the most commonly reported AEs during the first year of follow-up. The identified predictors of AEs may facilitate discussions between clinicians and patients prior to commencing MTX, and may lead to increased adherence and consequently improved effectiveness. Disclosure  A.A. Sherbini: None. J.M. Gwinnutt: Grants/research support; BMS. K.L. Hyrich: Member of speakers’ bureau; Abbvie. Grants/research support; Pfizer, UCB, BMS. S.M.M. Verstappen: Consultancies; Celltrion. Member of speakers’ bureau; Pfizer. Grants/research support; BMS.

scholarly journals Bioabsorbable Implant for Treatment of Nasal Valve Collapse with or without Concomitant Procedures

2021 ◽  
Author(s):  
Douglas M. Sidle ◽  
Pablo Stolovitzky ◽  
Ellen M. O'Malley ◽  
Randall A. Ow ◽  
Nathan E. Nachlas ◽  
...  
Keyword(s):  
Adverse Events ◽  
Nasal Obstruction ◽  
Large Population ◽  
Inferior Turbinate ◽  
Nasal Valve ◽  
Serious Adverse Events ◽  
Vas Scores ◽  
Nasal Implant ◽  
Nasal Valve Collapse

AbstractThe aim of the study is to report outcomes after treatment of nasal valve collapse with a bioabsorbable nasal implant. It involves two prospective, multicenter, post-market studies evaluating long-term effectiveness of the LATERA implant for severe to extreme nasal obstruction. Participants underwent implant alone or with concomitant inferior turbinate reduction (ITR) and/or septoplasty. Outcome measures included the change from baseline Nasal Obstruction Symptom Evaluation (NOSE) scores, NOSE responder rates, visual analog scale (VAS) scores, and adverse events. A total cohort of 277 participants (109 implants only, 67 implants + ITR, 101 implants + septoplasty + ITR) enrolled at 19 U.S. centers was available for analysis with 177 participants (69 implants only, 39 implants + ITR, 69 implants + septoplasty + ITR) available at 2 years. The mean changes from baseline in NOSE scores and VAS scores were statistically significant (p < 0.001) at all follow-up periods. The baseline NOSE score of 77.8 ± 13.6 was improved to 24.2 ± 23.6 at 24 months. Greater than 90% of participants were NOSE responders across all follow-up periods, 6.1% withdrew for lack of treatment effect. The baseline VAS score of 66.7 ± 18.8 was improved to 21.1 ± 23.9 at 24 months. There were no serious adverse events related to the device or implant procedure. Implant retrieval rate was 4.0% (22/543 implants). Nonserious adverse events were mild to moderate in severity, typically occurred within 6 months of implant, and resolved or were stable. Significant reductions in NOSE and VAS scores and high responder rates from our large population of patients with nasal obstruction who had nasal valve implants confirm sustained effectiveness at 24 months after treatment. The studies are registered on www.clinicaltrials.gov (NCT02952313 and NCT02964312).

scholarly journals AB1158 VACCINATION BARRIERS IN PATIENTS WITH RHEUMATIC DISEASES

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1869.2-1870
Author(s):  
G. Figueroa-Parra ◽  
A. Moreno-Salinas ◽  
L. Santoyo-Fexas ◽  
C. M. Gamboa-Alonso ◽  
A. L. De-Leon-Ibarra ◽  
...  
Keyword(s):  
Human Papillomavirus ◽  
Herpes Zoster ◽  
Hepatitis B ◽  
Adverse Events ◽  
Rheumatic Diseases ◽  
Demographic Characteristics ◽  
Specific Patient ◽  
Increased Risk ◽  
Rheumatic Patients ◽  
Vaccination Barriers

Background:Patients with rheumatic diseases (RD) are at increased risk of infections, attributed to the underlying RD, comorbidities and immunosuppressive therapy, including glucocorticoids, disease-modifying antirheumatic drugs, etc. (1). While many infectious diseases can generally be prevented by vaccines, immunization rates in this specific patient population remain suboptimal (2). Despite being recognized as one of the most successful public health measures, vaccination is perceived as unsafe and unnecessary by a growing number of individuals. Lack of confidence in vaccines is now considered a threat to the success of vaccination programs (3).Objectives:To describe the main causes of non-vaccination in patients with RD.Methods:A self-questionnaire was applied to a sample of patients with RD in the rheumatology clinic of the university hospital “Dr. Jose Eleuterio Gonzalez” in Monterrey, Mexico between September and December 2019. The questionnaire evaluated demographic characteristics (age, gender, diagnosis) and the vaccination status for Influenza (last year), pneumococcal (last 5 years), Herpes zoster (ever), Human papillomavirus (any dose) and Hepatitis B (any dose). It also includes a question asking: If you didn’t receive any of the previous vaccines, what was the reason? (multiple-choice are shown in Table 2). Results are shown in frequencies and percentages.Table 2.Vaccination barriersN=82If you didn’t receive any of the previous vaccines,what was the reason? n (%)1)Did not was recommended22 (26.8)2) Lack of availability21 (25.6)3) Vaccines don’t work13 (15.8)4) Fear of adverse events8 (9.7)5) Previous adverse event3 (3.6)6) Other reason- Own decision8 (9.7)- Disinformation7 (8.5)Results:102 patients were evaluated: Mean age was 51.27 (SD 14.68) years; 84 (82.4%) were females; 71 (69.6%) had rheumatoid arthritis, 13 (12.7%) had systemic lupus erythematosus, 6 (5.8%) had other autoimmune diseases and 12 (11.8%) had osteoarthritis. The rate of vaccination for Influenza was 49 (48%), for pneumococcal 25 (24.5%), for Herpes zoster 5 (4.9%), for Human papillomavirus 9 (8.8%), for Hepatitis B 14 (13.7%) (Table 1). 82 (80.3%) patients reported some barriers in vaccination, from these: 22 (26.8%) did not get the recommendation from the rheumatologist, 21 (25.6%) did not found available the vaccine, 13 (15.8%) believes that vaccines don’t work, 8 (9.7%) had fear of adverse events, 3 (3.6%) reported previous adverse events, and 15 (18.2%) reported other reasons, that we classified as own decision 8 (9.7%) and disinformation 7 (8.5%) (Table 2).Table 1.Demographic characteristicsN= 102Age, years, mean (SD)51.27 (14.68)Female, n (%)84 (82.4)Diagnosis, n (%)-RA71 (69.6)-SLE13 (12.7)-OA12 (11.8)-Other AID6 (5.8)Conclusion:The main barriers in vaccination of rheumatic patients reported were the lack of availability of the indicated vaccines and the medical and patient disinformation. This problem must be combated to ensure the complete vaccination of rheumatic patients.References:[1]Ann Rheum Dis. 2020;79:39-52.[2]J Rheumatol. 2019;46(7):751-754[3]Hum Vaccin Immunother. 2013;9(8):1763-73.Disclosure of Interests:None declared

scholarly journals POS0647 EFFICACY, SAFETY AND CHARACTERISTICS OF IGURATIMOD-BASED THERAPY IN THE TREATMENT OF UA, ERA AND RA PATIENTS FOR 24 WEEKS: A PROSPECTIVE COHORT STUDY

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 561.2-562
Author(s):  
X. Liu ◽  
Z. Sun ◽  
W. Guo ◽  
F. Wang ◽  
L. Song ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Cohort Study ◽  
Adverse Events ◽  
Disease Activity ◽  
Prospective Cohort Study ◽  
Early Rheumatoid Arthritis ◽  
Prospective Cohort ◽  
Combined Treatment ◽  
Serious Adverse Events

Background:Experts emphasize early diagnosis and treatment in RA, but the widely used diagnostic criterias fail to meet the accurate judgment of early rheumatoid arthritis. In 2012, Professor Zhanguo Li took the lead in establishing ERA “Chinese standard”, and its sensitivity and accuracy have been recognized by peers. However, the optimal first-line treatment of patients (pts) with undifferentiated arthritis (UA), early rheumatoid arthritis (ERA), and rheumatoid arthritis (RA) are yet to be established.Objectives:To evaluate the efficacy and safety of Iguratimod-based (IGU-based) Strategy in the above three types of pts, and to explore the characteristics of the effects of IGU monotherapy and combined treatment.Methods:This prospective cohort study (ClinicalTrials.gov Identifier NCT01548001) was conducted in China. In this phase 4 study pts with RA (ACR 1987 criteria[1]), ERA (not match ACR 1987 criteria[1] but match ACR/EULAR 2010 criteria[2] or 2014 ERA criteria[3]), UA (not match classification criteria for ERA and RA but imaging suggests synovitis) were recruited. We applied different treatments according to the patient’s disease activity at baseline, including IGU monotherapy and combination therapies with methotrexate, hydroxychloroquine, and prednisone. Specifically, pts with LDA and fewer poor prognostic factors were entered the IGU monotherapy group (25 mg bid), and pts with high disease activity were assigned to combination groups. A Chi-square test was applied for comparison. The primary outcomes were the proportion of pts in remission (REM)or low disease activity (LDA) that is DAS28-ESR<2.6 or 3.2 at 24 weeks, as well as the proportion of pts, achieved ACR20, Boolean remission, and good or moderate EULAR response (G+M).Results:A total of 313 pts (26 pts with UA, 59 pts with ERA, and 228 pts with RA) were included in this study. Of these, 227/313 (72.5%) pts completed the 24-week follow-up. The results showed that 115/227 (50.7%), 174/227 (76.7%), 77/227 (33.9%), 179/227 (78.9%) pts achieved DAS28-ESR defined REM and LDA, ACR20, Boolean remission, G+M response, respectively. All parameters continued to decrease in all pts after treatment (Fig 1).Compared with baseline, the three highest decline indexes of disease activity at week 24 were SW28, CDAI, and T28, with an average decline rate of 73.8%, 61.4%, 58.7%, respectively. Results were similar in three cohorts.We performed a stratified analysis of which IGU treatment should be used in different cohorts. The study found that the proportion of pts with UA and ERA who used IGU monotherapy were significantly higher than those in the RA cohort. While the proportion of triple and quadruple combined use of IGU in RA pts was significantly higher than that of ERA and UA at baseline and whole-course (Fig 2).A total of 81/313 (25.8%) pts in this study had adverse events (AE) with no serious adverse events. The main adverse events were infection(25/313, 7.99%), gastrointestinal disorders(13/313, 4.15%), liver dysfunction(12/313, 3.83%) which were lower than 259/2666 (9.71%) in the previous Japanese phase IV study[4].The most common reasons of lost follow-up were: 1) discontinued after remission 25/86 (29.1%); 2) lost 22/86 (25.6%); 3) drug ineffective 19/86 (22.1%).Conclusion:Both IGU-based monotherapy and combined therapies are tolerant and effective for treating UA, ERA, and RA, while the decline in joint symptoms was most significant. Overall, IGU combination treatments were most used in RA pts, while monotherapy was predominant in ERA and UA pts.References:[1]Levin RW, et al. Scand J Rheumatol 1996, 25(5):277-281.[2]Kay J, et al. Rheumatology 2012, 51(Suppl 6):vi5-9.[3]Zhao J, et al. Clin Exp Rheumatol 2014, 32(5):667-673.[4]Mimori T, et al. Mod Rheumatol 2019, 29(2):314-323.Disclosure of Interests:None declared

scholarly journals 416 - Risk of Mortality Associated with Antipsychotics in Alzheimer's Disease

2020 ◽  
Vol 32 (S1) ◽  
pp. 132-132
Author(s):  
Liliana P. Ferreira ◽  
Núria Santos ◽  
Nuno Fernandes ◽  
Carla Ferreira
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Adverse Events ◽  
Mortality Risk ◽  
Antipsychotic Treatment ◽  
Serious Adverse Events ◽  
Risk Of Death ◽  
Mesh Terms ◽  
Risk Of Mortality ◽  
Increased Risk

Objectives: Alzheimer's disease (AD) is the most common cause of dementia and it is associated with increased mortality. The use of antipsychotics is common among the elderly, especially in those with dementia. Evidence suggests an increased risk of mortality associated with antipsychotic use. Despite the short-term benefit of antipsychotic treatment to reduce the behavioral and psychological symptoms of dementia, it increases the risk of mortality in patients with AD. Our aim is to discuss the findings from the literature about risk of mortality associated with the use of antipsychotics in AD.Methods: We searched Internet databases indexed at MEDLINE using following MeSH terms: "Antipsychotic Agents" AND "Alzheimer Disease" OR "Dementia" AND "Mortality" and selected articles published in the last 5 years.Results: Antipsychotics are widely used in the pharmacological treatment of agitation and aggression in elderly patients with AD, but their benefit is limited. Serious adverse events associated with antipsychotics include increased risk of death. The risk of mortality is associated with both typical and atypical antipsychotics. Antipsychotic polypharmacy is associated with a higher mortality risk than monotherapy and should be avoided. The mortality risk increases after the first few days of treatment, gradually reducing but continues to increase after two years of treatment. Haloperidol is associated with a higher mortality risk and quetiapine with a lower risk than risperidone.Conclusions: If the use of antipsychotics is considered necessary, the lowest effective dose should be chosen and the duration should be limited because the mortality risk remains high with long-term use. The risk / benefit should be considered when choosing the antipsychotic. Further studies on the efficacy and risk of adverse events with antipsychotics are needed for a better choice of treatment and adequate monitoring with risk reduction.

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