scholarly journals AB1329 Biologic agents and risk of serious infections in rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis: results by integrating ten-year (X2006–2015) administrative databases in the italian region of friuli venezia giulia

Author(s):  
L. Quartuccio ◽  
A. Zabotti ◽  
S. Del Zotto ◽  
L. Zanier ◽  
S. De Vita ◽  
...  
2016 ◽  
Vol 43 (12) ◽  
pp. 2120-2130 ◽  
Author(s):  
Jonathan Kay ◽  
Roy Fleischmann ◽  
Edward Keystone ◽  
Elizabeth C. Hsia ◽  
Benjamin Hsu ◽  
...  

Objective.Assess 5-year golimumab (GOL) safety in rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS).Methods.Subcutaneous (SC) GOL (50 mg or 100 mg every 4 weeks) was evaluated in phase 3 trials of patients with active RA, PsA, and AS. Safety data through Year 5 were pooled across 3 RA trials [1 each evaluating methotrexate (MTX)-naive, MTX-experienced, and antitumor necrosis factor (TNF)-experienced patients], 1 PsA trial, and 1 AS trial. Data summarized was derived from both placebo-controlled (through weeks 24–52) and uncontrolled study periods. For adverse events (AE) of special interest [serious infections (SI), opportunistic infections (OI), deaths, malignancies, demyelination, tuberculosis (TB)], incidence per 100 patient-years (pt-yrs) was determined.Results.Across all trials, 639 patients received placebo and 2228 received SC GOL 50 mg only (n = 671), 50 mg and 100 mg (n = 765), or 100 mg only (n = 792). Safety followup extended for averages of 28.5 and 203.2 weeks for placebo and GOL, respectively. Respective placebo and GOL AE incidence/100 pt-yrs (95% CI) through Year 5 were 4.86 (2.83–7.78) and 3.29 (2.92–3.69) for SI, 0.00 (0.00–0.86) and 0.23 (0.14–0.35) for TB, 0.00 (0.00–0.86) and 0.22 (0.13–0.34) for OI, 0.00 (0.00–0.86) and 0.10 (0.05–0.20) for lymphoma, 0.00 (0.00–0.86) and 0.08 (0.03–0.17) for demyelination, and 0.29 (0.01–1.59) and 0.41 (0.29–0.57) for death. TB, OI, lymphoma, and demyelination incidence appeared to be higher among patients receiving GOL 100 mg only.Conclusion.SC GOL safety through Year 5 remained consistent with previously reported Year 3 findings and with other TNF antagonists. Numerically higher incidences of TB, OI, lymphoma, and demyelination were observed with 100 mg versus 50 mg. Clinicaltrials.gov identifiers: NCT00264537 (GO-BEFORE), NCT00264550 (GO-FORWARD), NCT00299546 (GO-AFTER), NCT00265096 (GO-REVEAL), and NCT00265083 (GO-RAISE).


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1557.2-1558
Author(s):  
L. Quartuccio ◽  
E. Treppo ◽  
S. De Vita ◽  
F. Valent

Background:ANCA-associated vasculitides (AAV) are a group of systemic vasculitis carrying a high risk of hospitalization because the multiorgan involvement, the acute nature of some clinical manifestations, the chronic but very disabling course of some other manifestations and finally the risk of severe infections due to chronic glucocorticoid and immunosuppressor administration. However, data on hospitalization due to ANCA-associated vasculitis are still scarce.Objectives:to estimate the rate of the first hospitalization or the death in patients suffering from AAV in the Italian region of Friuli Venezia Giulia (about 1,200,000 inhabitants) from year 2013 to 2017.Methods:integration of the information coming from many administrative databases were used to this end. The Regional Health Information System of Friuli Venezia Giulia was used as the source of information for this retrospective cohort study. The system covers the entire regional population and includes various electronic health administrative databases that can be linked with one another on an individual basis through a unique encrypted identifier. In particular, the following databases were matched: the database of the regional potential health care beneficiaries (including demographic information and the residential history of all of the subjects living in the region), the hospital discharge database, the database of exemptions from medical charges were used for this study, the database of the different regional laboratories. The population under study was selected based on the following inclusion criteria: patients were residents in Friuli Venezia Giulia and they had to carry the exemption code for AAV, including Granulomatosis with Polyangiitis (GPA), or Eosinophilic Granulomatosis with Polyangiitis (EGPA), or Microscopic Polyangiitis (MPA). This population was observed from 2013 to 2017. The coded event was the occurrence of the first hospitalization or the death. Also, all the hospitalization and their main discharge diagnoses were registered.Results:103 patient with AAV were identified. The number of patients with at least one hospitalization/death was 74/103 (71,8%). Seven patients died during the observation period (6,6%). The whole number of hospitalizations was 285 in 74 patients. 55/74 (74,3%) patients experienced more than one hospitalization. In the majority of the hospitalizations (119/285, 41,7%), the cause of hospitalization was directly attributable to the disease itself, while the second cause of hospitalization was the infections (26/285, 9,1%). In 10/103 patients (9,7%), an end stage renal disease was recorded as event. The presence of at least one positivity for ANCA antibodies was documented in 76/103 patients (73,8%), mainly in patients carrying GPA. Globally, the presence of ANCA antibody seems to be associated with greater likelihood of an event (p=0,07, log-rank test). The first event occurred in 50% of ANCA-positive patients within 180 days from diagnosis, while in 50% of ANCA negative patients in 859 days. 6 out of the 7 deaths occurred in ANCA positive patients.Conclusion:the rate of hospitalization in AAV is very high confirming the high health care burden of illness. The disease itself is often the cause of the hospitalization, as well as the infectious complication, highlighting the need for more effective treatments, and glucocorticoid sparing therapies. ANCA antibody may represent a biomarker of a more serious disease.Disclosure of Interests:Luca Quartuccio Consultant of: Abbvie, Bristol, Speakers bureau: Abbvie, Pfizer, Elena Treppo: None declared, Salvatore De Vita Consultant of: Roche, GSK, Speakers bureau: Roche, GSK, Novartis, Francesca Valent: None declared


2016 ◽  
Vol 83 (5) ◽  
pp. 607-609 ◽  
Author(s):  
Benjamin Batteux ◽  
Agathe Devauchelle ◽  
Pauline Lasselin Boyard ◽  
Alice Sejourné ◽  
Patrice Fardellone ◽  
...  

2020 ◽  
pp. 263-306
Author(s):  
Charlotte Frise ◽  
Sally Collins

This chapter covers rheumatic diseases in the pregnant patient. It gives background, clinical features, and management in the pregnant patient for rheumatoid arthritis, Sjögren’s syndrome, psoriatic arthritis, systemic lupus erythematosus, antiphospholipid syndrome, and ankylosing spondylitis among others. It also covers systemic sclerosis, osteoporosis, and other musculoskeletal problems. Medications and the use of biologics in pregnancy are also discussed, with reference to breastfeeding.


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