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  1. Book: Cirroz pečeni i portal'naja gipertenzija

    Ivanov, Anatolij Jakovlevič / Napalkov, Pavel Nikolaevič

    1968  

    Author's details Minist. zdravooch. RSFSR. Leningrads. sanitarnogigien. med. in-t.. Red.: A[natolij] Ja[kovlevič] Ivanov ; P[avel] N[ikolaevič] Napalkov [u.a.]
    Language Russian
    Size 311 S. ; 4-o
    Publisher Izd-vo Medicina
    Publishing place Leningrad
    Publishing country Russian Federation
    Document type Book
    HBZ-ID HT008219149
    Database Catalogue ZB MED Medicine, Health

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    1970 A 297 order for loan Magazin

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  2. Article: Comprehensive pan-cancer genomic landscape of KRAS altered cancers and real-world outcomes in solid tumors.

    Lee, Jessica K / Sivakumar, Smruthy / Schrock, Alexa B / Madison, Russell / Fabrizio, David / Gjoerup, Ole / Ross, Jeffrey S / Frampton, Garrett M / Napalkov, Pavel / Montesion, Meagan / Schutzman, Jennifer L / Ye, Xin / Hegde, Priti S / Nagasaka, Misako / Oxnard, Geoffrey R / Sokol, Ethan S / Ou, Sai-Hong Ignatius / Shi, Zhen

    NPJ precision oncology

    2022  Volume 6, Issue 1, Page(s) 91

    Abstract: Recent clinical development of KRAS inhibitors has heightened interest in the genomic landscape of KRAS-altered cancers. We performed a pan-cancer analysis of KRAS-altered samples from 426,706 adult patients with solid or hematologic malignancies using ... ...

    Abstract Recent clinical development of KRAS inhibitors has heightened interest in the genomic landscape of KRAS-altered cancers. We performed a pan-cancer analysis of KRAS-altered samples from 426,706 adult patients with solid or hematologic malignancies using comprehensive genomic profiling; additional analyses included 62,369 liquid biopsy and 7241 pediatric samples. 23% of adult pan-cancer samples had KRAS alterations; 88% were mutations, most commonly G12D/G12V/G12C/G13D/G12R, and prevalence was similar in liquid biopsies. Co-alteration landscapes were largely similar across KRAS mutations but distinct from KRAS wild-type, though differences were observed in some tumor types for tumor mutational burden, PD-L1 expression, microsatellite instability, and other mutational signatures. Prognosis of KRAS-mutant versus other genomic cohorts of lung, pancreatic, and colorectal cancer were assessed using a real-world clinicogenomic database. As specific KRAS inhibitors and combination therapeutic strategies are being developed, genomic profiling to understand co-alterations and other biomarkers that may modulate response to targeted or immunotherapies will be imperative.
    Language English
    Publishing date 2022-12-09
    Publishing country England
    Document type Journal Article
    ISSN 2397-768X
    ISSN 2397-768X
    DOI 10.1038/s41698-022-00334-z
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  3. Article ; Online: Incidence of giant cell arteritis and characteristics of patients: data-driven analysis of comorbidities.

    Petri, Hans / Nevitt, Alan / Sarsour, Khaled / Napalkov, Pavel / Collinson, Neil

    Arthritis care & research

    2015  Volume 67, Issue 3, Page(s) 390–395

    Abstract: Objective: To establish the incidence of giant cell arteritis (GCA), cumulative use of prednisolone, and comorbidities most associated with GCA.: Methods: The data source was the UK Clinical Practice Research Datalink. Selection criteria included ≥1 ... ...

    Abstract Objective: To establish the incidence of giant cell arteritis (GCA), cumulative use of prednisolone, and comorbidities most associated with GCA.
    Methods: The data source was the UK Clinical Practice Research Datalink. Selection criteria included ≥1 record of a diagnostic term for GCA between January 1, 2000 and December 31, 2011, age ≥50 years, and ≥1 prescription of oral or systemic corticosteroid. Controls were selected randomly (2:1), with year of birth, practice, and followup duration (<2 or ≥2 years) as matching variables. Analysis was data driven; all comorbidities were identified in a 2-year window, with relative risk (RR) calculated and rank ordered.
    Results: A total of 4,671 patients fulfilled the definition of GCA (incidence, 1.0 per 10,000 person-years), with highest incidence (7.4 per 10,000 person-years) in women ages 70-79 years. Of the 4,671 patients, 4,655 (99.7%) were prescribed prednisolone. In the group with ≥2 years' followup (n = 3,074), the mean number of prednisolone prescriptions was 32.1, and the mean cumulative dose was 8,640 mg; 1,034 patients (33.4%) received a cumulative dose of ≥10,000 mg. Comorbidities strongly associated with GCA were polymyalgia rheumatica (RR 14.9, 95% confidence interval [95% CI] 11.9-18.7), visual disturbances (RR 4.6, 95% CI 2.7-7.8), facial pain (RR 3.3, 95% CI 2.1-5.3), osteoporosis (RR 2.9, 95% 2.3-3.7), hypokalemia (RR 2.5, 95% CI 1.6-3.9), and various infections such as oral/esophageal thrush (RR 3.7, 95% CI 2.2-6.0) and herpes zoster (RR 2.6, 95% CI 1.6-4.1).
    Conclusion: GCA is relatively uncommon; its incidence peaks at age 70-79 years in women. Overall, GCA patients in the UK are treated with high cumulative prednisolone doses. Many conditions are associated with GCA, including several related to corticosteroid use.
    MeSH term(s) Age Distribution ; Age Factors ; Aged ; Comorbidity ; Databases, Factual ; Drug Prescriptions ; Female ; Giant Cell Arteritis/diagnosis ; Giant Cell Arteritis/drug therapy ; Giant Cell Arteritis/epidemiology ; Glucocorticoids/administration & dosage ; Glucocorticoids/adverse effects ; Humans ; Incidence ; Male ; Middle Aged ; Odds Ratio ; Prednisolone/administration & dosage ; Prednisolone/adverse effects ; Prevalence ; Primary Health Care ; Risk Factors ; Sex Distribution ; Sex Factors ; Time Factors ; Treatment Outcome ; United Kingdom/epidemiology
    Chemical Substances Glucocorticoids ; Prednisolone (9PHQ9Y1OLM)
    Language English
    Publishing date 2015-03
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 645059-3
    ISSN 2151-4658 ; 0893-7524 ; 2151-464X
    ISSN (online) 2151-4658
    ISSN 0893-7524 ; 2151-464X
    DOI 10.1002/acr.22429
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    Zs.A 2446: Show issues Location:
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  4. Article ; Online: Rheumatoid arthritis and the incidence of influenza and influenza-related complications

    Blumentals William A / Arreglado Anna / Napalkov Pavel / Toovey Stephen

    BMC Musculoskeletal Disorders, Vol 13, Iss 1, p

    a retrospective cohort study

    2012  Volume 158

    Abstract: Abstract Background Patients with rheumatoid arthritis (RA) are known to be at increased risk of infection, particularly if they are taking drugs with immunomodulatory effects. There is a need for more information on the risk of influenza in patients ... ...

    Abstract Abstract Background Patients with rheumatoid arthritis (RA) are known to be at increased risk of infection, particularly if they are taking drugs with immunomodulatory effects. There is a need for more information on the risk of influenza in patients with RA. Methods A retrospective cohort study was carried out using data gathered from a large US commercial health insurance database (Thomson Reuters Medstat MarketScan) from 1 January 2000 to 31 December 2007. Patients were ≥18 years of age, with at least two RA claims diagnoses. The database was scanned for incidence of seasonal influenza and its complications on or up to 30 days after an influenza diagnosis in RA patients and matched controls. Other factors accounted for included medical conditions, use of disease-modifying anti-rheumatic drugs (DMARDs), use of biological agents, influenza vaccination and high- or low-dose corticosteroids. Incidence rate ratios (IRRs) were calculated for influenza and its complications in patients with RA. Results 46,030 patients with RA and a matching number of controls had a median age of 57 years. The incidence of influenza was higher in RA patients than in controls (409.33 vs 306.12 cases per 100,000 patient-years), and there was a 2.75-fold increase in incidence of complications in RA. Presence or absence of DMARDs or biologics had no significant effect. The adjusted IRR of influenza was statistically significant in patients aged 60–69 years, and especially among men. A significantly increased rate of influenza complications was observed in women and in both genders combined (but not in men only) when all age groups were combined. In general, the risk of influenza complications was similar in RA patients not receiving DMARDs or biologics to that in all RA patients. Pneumonia rates were significantly higher in women with RA. Rates of stroke/myocardial infarction (MI) were higher in men, although statistical significance was borderline. Conclusions RA is associated with increased incidence of seasonal influenza and its complications. Gender- and age-specific subgroup data indicate that women generally have a greater rate of complications than men, but that men primarily have an increased rate of stroke and MI complications. Concomitant DMARD or biological use appears not to significantly affect the rate of influenza or its complications.
    Keywords Internal medicine ; RC31-1245 ; Medicine ; R ; DOAJ:Internal medicine ; DOAJ:Medicine (General) ; DOAJ:Health Sciences ; Diseases of the musculoskeletal system ; RC925-935
    Subject code 610
    Language English
    Publishing date 2012-08-01T00:00:00Z
    Publisher BioMed Central
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  5. Article ; Online: Incidence and complications of interstitial lung disease in users of tocilizumab, rituximab, abatacept and anti-tumor necrosis factor α agents, a retrospective cohort study.

    Curtis, Jeffrey R / Sarsour, Khaled / Napalkov, Pavel / Costa, Laurie A / Schulman, Kathy L

    Arthritis research & therapy

    2015  Volume 17, Page(s) 319

    Abstract: Introduction: Interstitial lung disease (ILD) is a common extra-articular condition in rheumatoid arthritis (RA), but few studies have systematically investigated its incidence and risk factors in patients receiving anti-tumor necrosis factor-alpha ( ... ...

    Abstract Introduction: Interstitial lung disease (ILD) is a common extra-articular condition in rheumatoid arthritis (RA), but few studies have systematically investigated its incidence and risk factors in patients receiving anti-tumor necrosis factor-alpha (anti-TNFα) agents or alternate mechanisms of action (MOAs) (e.g., T-cell, B-cell, and interleukin-6 inhibitors).
    Methods: RA patients at least 18 years old were selected from the MarketScan databases (2010-2012) if they had at least one prescription/administration of abatacept, rituximab, tocilizumab, or anti-TNF after having discontinued a different biologic agent and meeting enrollment criteria. Cox models estimated the risk of incident ILD and ILD-related hospitalization. Sensitivity analyses used an alternate ILD case definition.
    Results: We identified 13,795 episodes of biologic exposure in 11,219 patients. Mean (standard deviation) follow-up was 0.7 (0.5) years. Patients receiving alternate MOA agents were more likely to have had recent exposure to steroids, prior exposure to a greater number of biologics, and history of ILD, anemia, chronic obstructive pulmonary disease, and other pulmonary conditions. When the sensitive definition was used, unadjusted ILD incidence rates (95% confidence interval, or CI) ranged from 4.0 (1.6-8.2, abatacept) to 12.2 (5.6-23.2, infliximab) per 1000 person-years. Being older (hazard ratio (HR) 3.5; 95% CI 2.1-6.0), being male (HR 3.1; 95% CI 1.2-8.4), and having another pulmonary condition (HR 4.8; 95% CI 1.7-13.7) were associated with increased ILD incidence in either sensitive and/or specific models. There were no significant differences by biologic class. Hospitalization rates (95% CI) when the sensitive definition was used ranged from 55.6 (6.7-200.7, tocilizumab) to 262.5 (71.5-672.2, infliximab). In Cox models, recent methotrexate exposure was associated with reduced ILD hospitalization (HR 0.16; 95% CI 0.06-0.46), whereas being male (HR 2.5; 95% CI 1.3-4.8) and having had a hospitalization for asthma (HR 3.4; 95% CI 1.2-9.8) or ILD/pneumonia (HR 2.3; 95% CI 1.1-4.7) in the 12 months prior to index were associated with increased hospitalization risk.
    Conclusions: There were no significant differences in the risk of ILD and its related complications between RA patients receiving anti-TNFα agents and those receiving alternate MOA agents. Further studies are needed that account for differences in baseline characteristics in order to fully evaluate the risk of ILD and its complications.
    MeSH term(s) Abatacept/therapeutic use ; Adult ; Aged ; Antibodies, Monoclonal, Humanized/therapeutic use ; Antirheumatic Agents/therapeutic use ; Arthritis, Rheumatoid/complications ; Arthritis, Rheumatoid/drug therapy ; Cohort Studies ; Female ; Humans ; Incidence ; Lung Diseases, Interstitial/complications ; Lung Diseases, Interstitial/epidemiology ; Male ; Middle Aged ; Retrospective Studies ; Rituximab/therapeutic use ; Tumor Necrosis Factor-alpha/antagonists & inhibitors
    Chemical Substances Antibodies, Monoclonal, Humanized ; Antirheumatic Agents ; Tumor Necrosis Factor-alpha ; Rituximab (4F4X42SYQ6) ; Abatacept (7D0YB67S97) ; tocilizumab (I031V2H011)
    Language English
    Publishing date 2015-11-11
    Publishing country England
    Document type Journal Article ; Research Support, N.I.H., Extramural ; Research Support, U.S. Gov't, P.H.S.
    ZDB-ID 2107602-9
    ISSN 1478-6362 ; 1478-6354
    ISSN (online) 1478-6362
    ISSN 1478-6354
    DOI 10.1186/s13075-015-0835-7
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    Zs.A 5490: Show issues Location:
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  6. Article ; Online: Rheumatoid arthritis and the incidence of influenza and influenza-related complications: a retrospective cohort study.

    Blumentals, William A / Arreglado, Anna / Napalkov, Pavel / Toovey, Stephen

    BMC musculoskeletal disorders

    2012  Volume 13, Page(s) 158

    Abstract: Background: Patients with rheumatoid arthritis (RA) are known to be at increased risk of infection, particularly if they are taking drugs with immunomodulatory effects. There is a need for more information on the risk of influenza in patients with RA.!## ...

    Abstract Background: Patients with rheumatoid arthritis (RA) are known to be at increased risk of infection, particularly if they are taking drugs with immunomodulatory effects. There is a need for more information on the risk of influenza in patients with RA.
    Methods: A retrospective cohort study was carried out using data gathered from a large US commercial health insurance database (Thomson Reuters Medstat MarketScan) from 1 January 2000 to 31 December 2007. Patients were ≥18 years of age, with at least two RA claims diagnoses. The database was scanned for incidence of seasonal influenza and its complications on or up to 30 days after an influenza diagnosis in RA patients and matched controls. Other factors accounted for included medical conditions, use of disease-modifying anti-rheumatic drugs (DMARDs), use of biological agents, influenza vaccination and high- or low-dose corticosteroids. Incidence rate ratios (IRRs) were calculated for influenza and its complications in patients with RA.
    Results: 46,030 patients with RA and a matching number of controls had a median age of 57 years. The incidence of influenza was higher in RA patients than in controls (409.33 vs 306.12 cases per 100,000 patient-years), and there was a 2.75-fold increase in incidence of complications in RA. Presence or absence of DMARDs or biologics had no significant effect. The adjusted IRR of influenza was statistically significant in patients aged 60-69 years, and especially among men. A significantly increased rate of influenza complications was observed in women and in both genders combined (but not in men only) when all age groups were combined. In general, the risk of influenza complications was similar in RA patients not receiving DMARDs or biologics to that in all RA patients. Pneumonia rates were significantly higher in women with RA. Rates of stroke/myocardial infarction (MI) were higher in men, although statistical significance was borderline.
    Conclusions: RA is associated with increased incidence of seasonal influenza and its complications. Gender- and age-specific subgroup data indicate that women generally have a greater rate of complications than men, but that men primarily have an increased rate of stroke and MI complications. Concomitant DMARD or biological use appears not to significantly affect the rate of influenza or its complications.
    MeSH term(s) Adolescent ; Adult ; Aged ; Antirheumatic Agents/therapeutic use ; Arthritis, Rheumatoid/diagnosis ; Arthritis, Rheumatoid/drug therapy ; Arthritis, Rheumatoid/epidemiology ; Comorbidity ; Female ; Humans ; Immunization ; Incidence ; Influenza Vaccines/therapeutic use ; Influenza, Human/complications ; Influenza, Human/diagnosis ; Influenza, Human/epidemiology ; Influenza, Human/prevention & control ; Male ; Middle Aged ; Retrospective Studies ; Risk Factors ; Seasons ; Time Factors ; United States/epidemiology ; Young Adult
    Chemical Substances Antirheumatic Agents ; Influenza Vaccines
    Language English
    Publishing date 2012-08-27
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2041355-5
    ISSN 1471-2474 ; 1471-2474
    ISSN (online) 1471-2474
    ISSN 1471-2474
    DOI 10.1186/1471-2474-13-158
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  7. Article: Malignancy rates in patients with rheumatoid arthritis treated with tocilizumab.

    Rubbert-Roth, Andrea / Sebba, Anthony / Brockwell, Laura / Kelman, Ariella / Porter-Brown, Benjamin / Pulley, Jennifer / Napalkov, Pavel / van Vollenhoven, Ronald F

    RMD open

    2016  Volume 2, Issue 1, Page(s) e000213

    Abstract: Objective: To analyse malignancy rates in patients with rheumatoid arthritis (RA) treated with tocilizumab.: Methods: Patients who received tocilizumab or placebo+methotrexate/disease-modifying antirheumatic drugs in the double-blind phases of 5- ... ...

    Abstract Objective: To analyse malignancy rates in patients with rheumatoid arthritis (RA) treated with tocilizumab.
    Methods: Patients who received tocilizumab or placebo+methotrexate/disease-modifying antirheumatic drugs in the double-blind phases of 5-phase three trials or who received at least 1 dose of tocilizumab in the long-term extension studies were analysed up to the 2 May 2012 cut-off date. Malignancies were monitored throughout the studies, analysed and adjudicated as malignant by medical review. Risk was compared with that in the general population using standardised incidence ratios (SIRs) based on data from the Surveillance Epidemiology and End Results SEER (US general population) and GLOBOCAN (non-US general population) databases.
    Results: In total, 4009 patients in the tocilizumab all-exposure population were included. Mean treatment duration was 4.0 years (mean 5.1 (range 0.0-6.8); total observation time was 16 120.1 patient-years (PY). The adjudicated malignancy rate (95% CI) was 1.26/100 PY (1.09 to 1.44) and remained constant over time. The SIR (95% CI) for all malignancies combined, excluding non-melanoma skin cancer, was 1.36 (1.01 to 1.80) for US and 1.81 (1.44 to 2.23) for non-US populations, driven primarily by higher rates in lung and bronchus (US/non-US) malignancies and prostate cancer and non-Hodgkin lymphoma (non-US), in contrast to those for the general populations; these higher rates are in line with those expected in patients with RA or in the geographic regions studied.
    Conclusions: Malignancy rates remained stable with long-term tocilizumab treatment, and malignancy types and rates were consistent with those expected in patients with RA.
    Language English
    Publishing date 2016
    Publishing country England
    Document type Journal Article
    ZDB-ID 2812592-7
    ISSN 2056-5933
    ISSN 2056-5933
    DOI 10.1136/rmdopen-2015-000213
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  8. Article ; Online: Corticosteroid-related adverse events in patients with giant cell arteritis: A claims-based analysis.

    Broder, Michael S / Sarsour, Khaled / Chang, Eunice / Collinson, Neil / Tuckwell, Katie / Napalkov, Pavel / Klearman, Micki

    Seminars in arthritis and rheumatism

    2016  Volume 46, Issue 2, Page(s) 246–252

    Abstract: Objective: Corticosteroids (CS) are standard treatment for giant cell arteritis (GCA), but concerns persist over toxicities associated with long-term use. In this retrospective study of medical claims data, we estimated risks for adverse events (AEs) in ...

    Abstract Objective: Corticosteroids (CS) are standard treatment for giant cell arteritis (GCA), but concerns persist over toxicities associated with long-term use. In this retrospective study of medical claims data, we estimated risks for adverse events (AEs) in CS-treated GCA patients.
    Methods: Cox regression analyses with CS use as a time-dependent variable were conducted on data from the 2003 to 2012 Truven Health Analytics MarketScan Database. Patients 50 years of age and older who had ≥2 claims of newly diagnosed GCA, ≥1 filled oral CS prescription, and no AEs before GCA diagnosis were included. The primary outcome was presence of a new CS-related AE.
    Results: In total, 2497 patients were included. Their mean age was 71.0 years, and 71% were women. Follow-up was 9680 patient-years (PY). CS treatment continued for a mean (SD) of 1.196 (729.2) days; mean (SD) prescribed cumulative CS dose was 6983.3mg (6519.9). The overall AE rate was 0.43 events/PY; the most frequent AEs were cataract and bone disease. For each 1000-mg increase in CS exposure, the hazard ratio (HR) increased by 3% (HR = 1.03; 95% CI: 1.02-1.05; P < 0.001). Additionally, statistically significant individual associations between increased CS exposure and AE risk were observed for bone-related AEs (P < 0.001), cataract (P < 0.001), glaucoma (P = 0.005), pneumonia (P = 0.003), and diabetes mellitus (P < 0.001 in a subset of patients with no previous history of diabetes).
    Conclusion: CS exposure significantly increased risk for potentially serious AEs, emphasizing a need for new treatment options for GCA patients.
    MeSH term(s) Adrenal Cortex Hormones/adverse effects ; Adrenal Cortex Hormones/therapeutic use ; Aged ; Bone Diseases/chemically induced ; Cataract/chemically induced ; Databases, Factual ; Female ; Giant Cell Arteritis/drug therapy ; Humans ; Male ; Risk Assessment
    Chemical Substances Adrenal Cortex Hormones
    Language English
    Publishing date 2016-06-02
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 120247-9
    ISSN 1532-866X ; 0049-0172
    ISSN (online) 1532-866X
    ISSN 0049-0172
    DOI 10.1016/j.semarthrit.2016.05.009
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  9. Article ; Online: Incidence of catheter-related complications in patients with central venous or hemodialysis catheters: a health care claims database analysis.

    Napalkov, Pavel / Felici, Diana M / Chu, Laura K / Jacobs, Joan R / Begelman, Susan M

    BMC cardiovascular disorders

    2013  Volume 13, Page(s) 86

    Abstract: Background: Central venous catheter (CVC) and hemodialysis (HD) catheter usage are associated with complications that occur during catheter insertion, dwell period, and removal. This study aims to identify and describe the incidence rates of catheter- ... ...

    Abstract Background: Central venous catheter (CVC) and hemodialysis (HD) catheter usage are associated with complications that occur during catheter insertion, dwell period, and removal. This study aims to identify and describe the incidence rates of catheter-related complications in a large patient population in a United States-based health care claims database after CVC or HD catheter placement.
    Methods: Patients in the i3 InVision DataMart® health care claims database with at least 1 CVC or HD catheter insertion claim were categorized into CVC or HD cohorts using diagnostic and procedural codes from the US Renal Data System, American College of Surgeons, and American Medical Association's Physician Performance Measures. Catheter-related complications were identified using published diagnostic and procedural codes. Incidence rates (IRs)/1000 catheter-days were calculated for complications including catheter-related bloodstream infections (CRBSIs), thrombosis, embolism, intracranial hemorrhage (ICH), major bleeding (MB), and mechanical catheter-related complications (MCRCs).
    Results: Thirty percent of the CVC cohort and 54% of the HD cohort had catheter placements lasting <90 days. Catheter-related complications occurred most often during the first 90 days of catheter placement. IRs were highest for CRBSIs in both cohorts (4.0 [95% CI, 3.7-4.3] and 5.1 [95% CI, 4.7-5.6], respectively). Other IRs in CVC and HD cohorts, respectively, were thrombosis, 1.3 and 0.8; MCRCs, 0.6 and 0.7; embolism, 0.4 and 0.5; MB, 0.1 and 0.3; and ICH, 0.1 in both cohorts. Patients with cancer at baseline had significantly higher IRs for CRBSIs and thrombosis than non-cancer patients. CVC or HD catheter-related complications were most frequently seen in patients 16 years or younger.
    Conclusions: The risk of catheter-related complications is highest during the first 90 days of catheter placement in patients with CVCs and HD catheters and in younger patients (≤16 years of age) with HD catheters. Data provided in this study can be applied toward improving patient care.
    MeSH term(s) Adolescent ; Adult ; Aged ; Catheter-Related Infections/diagnosis ; Catheter-Related Infections/epidemiology ; Central Venous Catheters/adverse effects ; Child ; Child, Preschool ; Cohort Studies ; Cross Infection/diagnosis ; Cross Infection/epidemiology ; Female ; Humans ; Incidence ; Infant ; Insurance Claim Review ; Male ; Middle Aged ; Renal Dialysis/adverse effects ; Retrospective Studies ; Thrombosis/diagnosis ; Thrombosis/epidemiology ; Young Adult
    Language English
    Publishing date 2013-10-16
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2059859-2
    ISSN 1471-2261 ; 1471-2261
    ISSN (online) 1471-2261
    ISSN 1471-2261
    DOI 10.1186/1471-2261-13-86
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  10. Article ; Online: Tocilizumab in rheumatoid arthritis: a case study of safety evaluations of a large postmarketing data set from multiple data sources.

    Curtis, Jeffrey R / Perez-Gutthann, Susana / Suissa, Samy / Napalkov, Pavel / Singh, Natasha / Thompson, Liz / Porter-Brown, Benjamin

    Seminars in arthritis and rheumatism

    2015  Volume 44, Issue 4, Page(s) 381–388

    Abstract: Objectives: To evaluate the magnitude of serious adverse events (SAEs) observed in postmarketing reports of tocilizumab (TCZ) for rheumatoid arthritis (RA) in relation to SAEs observed in TCZ clinical trials and external epidemiology data.: Methods: ... ...

    Abstract Objectives: To evaluate the magnitude of serious adverse events (SAEs) observed in postmarketing reports of tocilizumab (TCZ) for rheumatoid arthritis (RA) in relation to SAEs observed in TCZ clinical trials and external epidemiology data.
    Methods: A total of 64,000 patient-years (PY) of TCZ exposure was needed to determine, with 90% power, whether rates of SAEs of interest (eg, death, hepatic, gastrointestinal, and cardiovascular) were ≥50% higher (agreed with the Food and Drug Administration) than expected. Reporting rates were calculated for spontaneously reported SAEs, open-label or unblinded postmarketing clinical trials (phase 3b/4), and a Japanese postmarketing surveillance program in the global postmarketing safety database. Event rates were calculated for the registrational placebo-controlled trials and long-term extension data. External comparators for anti-tumor necrosis factor (aTNF)-treated RA patients were derived from a US-based health care insurance claims database or published literature.
    Results: The global postmarketing safety database provided 65,099 PY of TCZ exposure; the aTNF external comparator population provided 53,360 PY. Spontaneous reporting rates per 100 PY (95% confidence interval) were 8.3 (8.1, 8.5) SAEs, 0.39 (0.34, 0.44) deaths, 0.06 (0.04, 0.08) serious hepatic events, 0.15 (0.12, 0.18) serious gastrointestinal events, 0.09 (0.07, 0.12) serious myocardial infarctions, 0.15 (0.12, 0.18) serious strokes, and 0.07 (0.05, 0.09) cardiac deaths in the global postmarketing safety database. These were of similar magnitude to corresponding rates from registrational clinical trials, the aTNF external comparator population, and published literature.
    Conclusions: SAE rates observed among postmarketing TCZ users were similar to those of various comparison populations. Predetermined design of studies to compare postmarketing AEs using multiple data sources is a useful strategy that can be applied to other medications.
    MeSH term(s) Aged ; Antibodies, Monoclonal, Humanized/adverse effects ; Antibodies, Monoclonal, Humanized/therapeutic use ; Arthritis, Rheumatoid/drug therapy ; Arthritis, Rheumatoid/mortality ; Cardiovascular Diseases/chemically induced ; Cardiovascular Diseases/epidemiology ; Chemical and Drug Induced Liver Injury/epidemiology ; Clinical Trials as Topic/statistics & numerical data ; Europe ; Female ; Gastrointestinal Diseases/chemically induced ; Gastrointestinal Diseases/epidemiology ; Humans ; Incidence ; Japan ; Male ; Middle Aged ; Product Surveillance, Postmarketing/statistics & numerical data ; Survival Rate ; United States
    Chemical Substances Antibodies, Monoclonal, Humanized ; tocilizumab (I031V2H011)
    Language English
    Publishing date 2015-02
    Publishing country United States
    Document type Comparative Study ; Evaluation Studies ; Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 120247-9
    ISSN 1532-866X ; 0049-0172
    ISSN (online) 1532-866X
    ISSN 0049-0172
    DOI 10.1016/j.semarthrit.2014.07.006
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