Posts filed under ‘Biológicos’

Risk of serious infections associated with use of immunosuppressive agents in pregnant women with autoimmune inflammatory conditions: cohort study.

BMJ. 2017 Mar 6;356:j895.

Desai RJ1, Bateman BT2,3, Huybrechts KF2, Patorno E2, Hernandez-Diaz S4, Park Y4, Dejene SZ2, Cohen J4, Mogun H2, Kim SC2.

Author information

1 Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA 02120, USA rdesai@bwh.harvard.edu.

2 Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA 02120, USA.

3 Department of Anesthesia, Critical Care, and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.

4 Department of Epidemiology, Harvard School of Public Health, Boston, MA, USA.

Abstract

Objective To compare the risk of serious infections associated with use of systemic steroids, non-biologic agents, or tumor necrosis factor α (TNF) inhibitors in pregnancy.

Design Observational cohort study.Setting Public (Medicaid, 2001-10) or private (Optum Clinformatics, 2004-15) health insurance programs in the US.Participants 4961 pregnant women treated with immunosuppressive drugs for rheumatoid arthritis, systemic lupus erythematosus, ankylosing spondylitis, psoriatic arthritis, or inflammatory bowel disease.Exposure for observational studies Exposure was classified into steroid, non-biologic, or TNF inhibitors on first filled prescription during pregnancy. Because TNF inhibitors are not used to treat systemic lupus erythematosus, patients with this condition were excluded from comparisons involving TNF inhibitors.Main outcome measure The main outcome was occurrence of serious infections during pregnancy, defined by hospital admission for bacterial or opportunistic infections. Hazard ratios were derived using Cox proportional hazard regression models after adjustment for confounding with propensity score fine stratification. A logistic regression model was used to conduct a dose-response analysis among women filling at least one steroid prescription.

Results 71 out of 4961 pregnant women (0.2%) treated with immunosuppressive agents experienced serious infections. The crude incidence rates of serious infections per 100 person years among 2598 steroid users, 1587 non-biologic users, and 776 TNF inhibitors users included in this study were 3.4 (95% confidence interval 2.5 to 4.7), 2.3 (1.5 to 3.5), and 1.5 (0.7 to 3.0), respectively. No statistically significant differences in the risk of serious infections during pregnancy were observed among users of the three immunosuppressive drug classes: non-biologics v steroids, hazard ratio 0.81 (95% confidence interval 0.48 to 1.37), TNF inhibitors v steroids 0.91 (0.36 to 2.26), and TNF inhibitors v non-biologics 1.36 (0.47 to 3.93). In the dose-response analysis, higher steroid dose was associated with an increased risk of serious infections during pregnancy (coefficient for each unit increase in average prednisone equivalent mg daily dose=0.019, P=0.02).

Conclusions Risk of serious infections is similar among pregnant women with systemic inflammatory conditions using steroids, non-biologics, and TNF inhibitors. However, high dose steroid use is an independent risk factor of serious infections in pregnancy.

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http://www.bmj.com/content/bmj/356/bmj.j895.full.pdf

April 13, 2017 at 8:37 am

Pneumocystis jirovecii Pneumonia in Rheumatoid Arthritis Patients: Risks and Prophylaxis Recommendations.

Clin Med Insights Circ Respir Pulm Med. 2015 Sep 6;9(Suppl 1):29-40.                   

Mori S1, Sugimoto M2.

Author information

1Department of Rheumatology, Clinical Research Center for Rheumatic Diseases, NHO Kumamoto Saishunsou National Hospital, Kumamoto, Japan.

2Division of Respiratory Medicine, Department of Medicine, Social Insurance Omuta Tenryo Hospital, Fukuoka, Japan.

Abstract

Pneumocystis jirovecii infection causes fulminant interstitial pneumonia (Pneumocystis pneumonia, PCP) in patients with rheumatoid arthritis (RA) who are receiving biological and/or nonbiological antirheumatic drugs. Recently, we encountered a PCP outbreak among RA outpatients at our institution. Hospital-acquired, person-to-person transmission appears to be the most likely mode of this cluster of P. jirovecii infection. Carriage of P. jirovecii seems a time-limited phenomenon in immunocompetent hosts, but in RA patients receiving antirheumatic therapy, clearance of this organism from the lungs is delayed. Carriers among RA patients can serve as sources and reservoirs of P. jirovecii infection for other susceptible patients in outpatient facilities. Development of PCP is a matter of time in such carriers. Considering the poor survival rates of PCP cases, prophylactic antibiotics should be considered for RA patients who are scheduled to receive antirheumatic therapy. Once a new case of PCP occurs, we should take prompt action not only to treat the PCP patient but also to prevent other patients from becoming new carriers of P. jirovecii. Short-term prophylaxis with trimethoprim-sulfamethoxazole is effective in controlling P. jirovecii infection and preventing future outbreaks of PCP among RA patients.

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4562607/pdf/ccrpm-suppl.1-2015-029.pdf

April 9, 2017 at 7:30 pm

Atypical Presentation of Disseminated Zoster in a Patient with Rheumatoid Arthritis.

Case Rep Med. 2015;2015:124840.     

Patel N1, Singh D1, Patel K1, Ahmed S1, Anand P1.

Author information

1Department of Medicine, Nassau University Medical Center, East Meadow, NY 11554, USA.

Abstract

Patients with rheumatoid arthritis (RA) have 2-fold increased risk of herpes zoster. In literature, limited information exists about disseminated cutaneous zoster in RA patients. An 83-year-old African-American female with RA presented with generalized and widespread vesicular rash covering her entire body. Comorbidities include hypertension, type II diabetes, and dyslipidemia. Patient was on methotrexate 12.5 mg and was not receiving any corticosteroids, anti-TNF therapy, or other biological agents. The patient was afebrile (98F) with no SIRS criteria. Multiple vesicular lesions were present covering patient’s entire body including face. Lesions were in different stages, some umbilicated with diameter of 2-7cm. Many lesions have a rim of erythema with no discharge. On admission, patient was also pancytopenic with leukocyte count of 1.70k/mm(3). Biopsies of lesions were performed, which were positive for Varicella antigen. Subsequently, patient was started on Acyclovir. The patient’s clinical status improved and rash resolved. Our patient presented with “atypical” clinical picture of disseminated cutaneous zoster with no obvious dermatome involvement. Disseminated zoster is a potentially serious infection that can have an atypical presentation in patients with immunocompromised status. High index of suspicion is needed to make the diagnosis promptly and to initiate therapy to decrease mortality and morbidity.

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4609790/pdf/CRIM2015-124840.pdf

April 9, 2017 at 7:29 pm

Specific management of post-chikungunya rheumatic disorders: a retrospective study of 159 cases in Reunion Island from 2006-2012.

PLoS Negl Trop Dis. 2015 Mar 11;9(3):e0003603.

Javelle E1, Ribera A2, Degasne I3, Gaüzère BA4, Marimoutou C5, Simon F1.

Author information

1Department of Tropical and Infectious Diseases, Laveran Military Teaching Hospital, Marseille, France.

2Private Rheumatology Office, Saint Denis, La Réunion, France.

3Department of Rheumatology, Centre Hospitalier Universitaire de La Réunion, Hôpital Felix Guyon, Saint Denis, La Réunion, France.

4Intensive Care Unit, Centre Hospitalier Universitaire de La Réunion, Hôpital Felix Guyon, Saint Denis, La Réunion, France.

5French Army Centre for Epidemiology and Public Health (“IRBA”), Marseille, France.

Abstract

BACKGROUND:

Since 2003, the tropical arthritogenic chikungunya (CHIK) virus has become an increasingly medical and economic burden in affected areas as it can often result in long-term disabilities. The clinical spectrum of post-CHIK (pCHIK) rheumatic disorders is wide. Evidence-based recommendations are needed to help physicians manage the treatment of afflicted patients.

PATIENTS AND METHODS:

We conducted a 6-year case series retrospective study in Reunion Island of patients referred to a rheumatologist due to continuous rheumatic or musculoskeletal pains that persisted following CHIK infection. These various disorders were documented in terms of their clinical and therapeutic courses. Post-CHIK de novo chronic inflammatory rheumatisms (CIRs) were identified according to validated criteria.

RESULTS:

We reviewed 159 patient medical files. Ninety-four patients (59%) who were free of any articular disorder prior to CHIK met the CIR criteria: rheumatoid arthritis (n=40), spondyloarthritis (n=33), undifferentiated polyarthritis (n=21). Bone lesions detectable by radiography occurred in half of the patients (median time: 3.5 years pCHIK). A positive therapeutic response was achieved in 54 out of the 72 patients (75%) who were treated with methotrexate (MTX). Twelve out of the 92 patients (13%) received immunomodulatory biologic agents due to failure of contra-indication of MTX treatment. Other patients mainly presented with mechanical shoulder or knee disorders, bilateral distal polyarthralgia that was frequently associated with oedema at the extremities and tunnel syndromes. These pCHIK musculoskeletal disorders (MSDs) were managed with pain-killers, local and/or general anti-inflammatory drugs, and physiotherapy.

CONCLUSION:

Rheumatologists in Reunion Island managed CHIK rheumatic disorders in a pragmatic manner following the outbreak in 2006. This retrospective study describes the common mechanical and inflammatory pCHIK disorders. We provide a diagnostic and therapeutic algorithm to help physicians deal with chronic patients, and to limit both functional and economic impacts. The therapeutic indication of MTX in pCHIK CIR could be approved in future efficacy trials.

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https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4356515/pdf/pntd.0003603.pdf

February 28, 2017 at 9:06 am

Infectious complications in chronic lymphocytic leukemia.

Mediterr J Hematol Infect Dis. 2012;4(1):e2012070. doi: 10.4084/MJHID.2012.070. Epub 2012 Nov 5.

Nosari A1.

Author information

1Divisione di Ematologia, Niguarda Ca’ Granda Hospital, Piazza Ospedale Maggiore 3 – 20162 Milano, Italy. Tel: 39-02-64442668.

Abstract

Infectious complications have been known to be a major cause of morbidity and mortality in Chronic Lymphocytic Leukemia (CLL) patients who are prone to infections because of both the humoral immunodepression inherent to the hematologic disease and to the immunosuppression related to the therapy.

The majority of infections in CLL patients treated with alkilating agents is of bacterial origin. The immunodeficiency and natural infectious history of alkylator-resistant, corticosteroid-treated patients appears to have changed with the administration of purine analogs, which has been complicated by very severe and unusual infections and also more viral infections due to sustained reduction of CD4-positive T lymphocytes.

The subsequent introduction of monoclonal antibodies in therapies, in particular alemtuzumab, further increased the immunodepression, increasing also infections which appeared more often in patients with recurrent neutropenia due to chemotherapy cycles.

Epidemiological data regarding fungal infections in lymphoproliferative disorders are scarce.

Italian SEIFEM group in a retrospective multicentre study regarding CLL patients reported an incidence of mycoses 0.5%; however, chronic lymphoproliferative disorders emerged as second haematological underlying disease after acute leukemia in a French study on aspergillosis; in particular CLL with aspergillosis accounted for a third of these chronic lymphoproliferative diseases presenting mould infection.

PDF

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3507529/pdf/mjhid-4-1-e2012070.pdf

February 23, 2017 at 7:49 am

Posterior Reversible Encephalopathy Syndrome and Fatal Cryptococcal Meningitis After Immunosuppression in a Patient With Elderly Onset Inflammatory Bowel Disease.

ACG Case Rep J. 2016 Aug 3;3(4):e98. eCollection 2016.

Vasant DH1, Limdi JK1, Borg-Bartolo SP1, Bonington A2, George R3.

Author information

1Department of Gastroenterology, Pennine Acute Hospitals NHS Trust, United Kingdom; Manchester Academic Health Sciences Centre, The University of Manchester, Manchester, United Kingdom.

2Department of Infectious Diseases, Pennine Acute Hospitals NHS Trust, United Kingdom; Manchester Academic Health Sciences Centre, The University of Manchester, Manchester, United Kingdom.

3Department of Gastroenterology, Pennine Acute Hospitals NHS Trust, United Kingdom.

Abstract

Advanced age and associated comorbidities are-recognized predictors of life-threatening adverse outcomes, such as opportunistic infection following immunosuppressive therapy.

We describe the case of an elderly patient with stricturing colonic Crohn’s disease and significant clinical comorbidities, initially controlled with corticosteroid induction followed by infliximab, whose course was complicated by fatal disseminated cryptococcal infection and posterior reversible encephalopathy syndrome.

Our patient’s case highlights rare, but serious, complications of immunosuppression.

In applying modern treatment paradigms to the elderly, the clinician must consider the potential for more pronounced adverse effects in this potentially vulnerable group, maximizing benefit and minimizing harm.

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https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5062660/pdf/CG-CGCR160009.pdf

February 10, 2017 at 8:54 am

Staphylococcus aureus bacteremia with iliac artery endarteritis in a patient receiving ustekinumab.

BMC Infect Dis. 2016 Oct 20;16(1):586.

Joost I1, Steinfurt J2, Meyer PT3, Kern WV4, Rieg S4.

Author information

1Division of Infectious Diseases, Department of Medicine II, University Medical Center Freiburg, Hugstetter Str. 55, Freiburg, 79106, Germany. insa.joost@uniklinik-freiburg.de

2Department of Cardiology and Angiology I, Heart Center, University of Freiburg, Hugstetter Strasse 55, Freiburg, 79106, Germany.

3Department of Nuclear Medicine, University Medical Center Freiburg, Hugstetter Str. 55, Freiburg, 79106, Germany.

4Division of Infectious Diseases, Department of Medicine II, University Medical Center Freiburg, Hugstetter Str. 55, Freiburg, 79106, Germany.

Abstract

BACKGROUND:

Ustekinumab (Stelara®), a human monoclonal antibody targeting the p40-subunit of interleukin (IL)-12 and IL-23, is indicated for moderate to severe plaque psoriasis and psoriatic arthritis. In large multicenter, prospective trials assessing efficacy and safety of ustekinumab increased rates of severe infections have not been observed so far.

CASE PRESENTATION:

Here, we report the case of a 64-year old woman presenting with chills, pain and swelling of her right foot with dark maculae at the sole, and elevated inflammatory markers. She had received a third dose of ustekinumab due to psoriatic arthritis three days before admission. Blood cultures revealed growth of Staphylococcus aureus and imaging showed a thickening of the aortic wall ventral the bifurcation above the right internal iliac artery, resembling an acute bacterial endarteritis. Without the evidence of aneurysms and in absence of foreign bodies, the decision for conservative management was made. The patient received four weeks of antibiotic therapy with intravenous flucloxacillin, followed by an oral regime with levofloxacin and rifampicin for an additional four weeks. Inflammatory markers resolved promptly and the patient was discharged in good health.

CONCLUSION:

To our knowledge, this is the first report of a severe S. aureus infection in a patient receiving ustekinumab. Albeit ustekinumab is generally regarded as a safe drug, severe bacterial infections should always be included in the differential diagnosis of elevated inflammatory markers in patients receiving biologicals as these might present with nonspecific symptoms and fever might be absent. Any effort to detect deep-seated or metastatic infections should be made to prevent complications and to secure appropriate treatment. Although other risk factors for an invasive staphylococcal infection like psoriasis, recent corticosteroid injection, or prior hospitalisations were present, and therefore a directive causative link between the S. aureus bacteraemia and ustekinumab can not be drawn, we considered the reporting of this case worthwhile to alert clinicians as we believe that ongoing pharmacovigilance to detect increased risks for rare but severe infections beyond phase II and phase III trials in patients treated with biologicals is essential.

PDF

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5072319/pdf/12879_2016_Article_1912.pdf

February 10, 2017 at 8:52 am

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