TNF alpha antagonist therapy and safety monitoring

Pham, Thao; Bachelez, Hervé; Berthelot, Jean‐Marie; Blacher, Jacques; Bouhnik, Yoram; Claudepierre, Pascal; Constantin, Arnaud; Fautrel, Bruno; Gaudin, Philippe; Goëb, Vincent; Gossec, Laure; Goupille, Philippe; Guillaume-Czitrom, S.; Hachulla, É.; Huet, Isabelle; Jullien, D.; Launay, Odile; Lémann, Marc; Maillefert, Jean-Françis; Marolleau, Jean‐Pierre; Martinez, Valérie; Masson, Charles; Morel, Jacques; Mouthon, Luc; Pol, S.; Puéchal, Xavier; Richette, Pascal; Saraux, Alain; Schaeverbeke, Thierry; Soubrier, Martin; Sudre, Anne; Tran, Tú-Anh; Viguier, Manuelle; Vittecoq, Olivier; Wendling, Daniel; Mariette, Xavier; Sibilia, Jean

doi:10.1016/s1297-319x(11)70001-x

Cited by 65 publications

(51 citation statements)

References 437 publications

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“…The safety risks associated with BRMs have been widely described in the literature and recommendations have been made for assessing and monitoring safe use of these agents. 17,29,30 It is widely believed that the introduction of BRMs has significantly improved patient outcomes for a variety of indicated diseases; however, the safety concerns require careful screening of candidates, especially in patients at risk for adverse events, for example, patients with certain comorbidities or patients receiving an immunomodulator along with BRMs. 29 Some have called for systems to monitor the safety and effectiveness of BRMs in everyday practice.…”

Section: ■■ Discussionmentioning

confidence: 99%

“…11 Hepatitis B viral status should be assessed prior to initiation of treatment and monitored or possibly treated in patients who are hepatitis B positive. 11,13,17,18 Liver function tests (LFT) and complete blood counts (CBC) are recommended prior to initiation and every 3 months or as frequently as the prescriber deems necessary during the course of therapy. This monitoring is performed to assess for opportunistic infections, malignancies, and liver abnormalities.…”

Section: Improvement In Safety Monitoring Of Biologic Response Modifimentioning

confidence: 99%

“…The Clinical Care Guidelines for BRMs was developed by a committee of pharmacists, nurses, and physicians at UI Health, based on an assessment of published literature and medication labeling. [4][5][6][7][8]11,14,17,18,[20][21][22][23][24][25][26][27] The guidelines were introduced to the health system in February 2012. The goal of the guidelines was to reinforce safety monitoring recommendations by assisting providers with clinical decisions for specific BRMs by implementing standardized monitoring and screening criteria.…”

Section: Improvement In Safety Monitoring Of Biologic Response Modifimentioning

confidence: 99%

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Improvement in Safety Monitoring of Biologic Response Modifiers After the Implementation of Clinical Care Guidelines by a Specialty Pharmacy Service in an Academic Health System

Hanson

Gannon

Khamo

et al. 2013

JMCP

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BACKGROUND: Tumor necrosis factor (TNF)-alpha inhibitors and other biologic response modifiers (BRMs) are frequently used to treat a variety of inflammatory diseases. Use of these agents may increase risk of serious infections, malignancies, and other complications such as worsening symptoms of heart failure or demyelinating disease. Because of these risks, a baseline assessment and routine monitoring have been recommended, but standardized guidelines for monitoring have yet to be established.

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Section: ■■ Discussionmentioning

confidence: 99%

Section: Improvement In Safety Monitoring Of Biologic Response Modifimentioning

confidence: 99%

Section: Improvement In Safety Monitoring Of Biologic Response Modifimentioning

confidence: 99%

See 1 more Smart Citation

Improvement in Safety Monitoring of Biologic Response Modifiers After the Implementation of Clinical Care Guidelines by a Specialty Pharmacy Service in an Academic Health System

Hanson

Gannon

Khamo

et al. 2013

JMCP

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“…Patients who have been curatively treated for nonmetastasized solid cancers should have a disease-free interval of at least 5 years before considering anti-TNF-α treatment, and treatment should probably not be considered in patients with previous cancers that have an unpredictable course such as malignant melanoma and breast cancer [38,39]. Previous lymphoma is considered an absolute contraindication of anti-TNF-α treatment [38]. …”

Section: Precautions Before Introducing Biologicalsmentioning

confidence: 99%

“…The IGRA test is more sensitive than the tuberculin skin test in patients on immunomodulator therapy, and is therefore recommended by the Centers for Disease Control and Prevention [41]. False-negative IGRA tests are encountered, and a careful clinical work-up and observation of patients to identify those at risk of developing tuberculosis is recommended in addition to the tuberculin skin test and the IGRA tests [38]. …”

Section: Precautions Before Introducing Biologicalsmentioning

confidence: 99%

Biological Treatment of Crohn’s Disease

Nielsen

Bjerrum²,

Seidelin³

et al. 2012

Dig Dis

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Introduction of biological agents for the treatment of Crohn’s disease (CD) has led to a transformation of the treatment paradigm. Several biological compounds have been approved for patients with CD refractory to conventional treatment: infliximab, adalimumab and certolizumab pegol (and natalizumab in several countries outside the European Union). However, despite the use of biologics for more than a decade, questions still remain about the true efficacy and the best treatment regimens – especially about when to discontinue treatment. Furthermore, a need for optimizing treatment with biologics still exists, as 20–40% of patients with CD (depending on selection criteria) do not have any relevant response to the current biological agents (i.e. primary failures). A better patient selection might maximize the clinical outcome while minimizing the complications associated with this type of therapy. However, the clinical tools capable of identifying such patients are still unavailable, and the trough level strategy may help the clinician to optimize therapy and to avoid loss of response and/or immunogenicity (i.e. a low but measurable antibody level exists just before the periodic administration of the biological agent). On the other hand, peak levels and average levels should not exceed concentrations associated with increased toxicity. Randomized, controlled studies focusing on trough levels and antibodies towards the biological agent in routine clinical situations may add important pieces to the puzzle for a more rational treatment algorithm of CD patients. In some situations, the risks (i.e. immunogenicity, serious infections and the promotion of neoplasia) may, however, not outweigh the benefits of biological treatment.

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Safety of Abatacept in Rheumatoid Arthritis With Serologic Evidence of Past or Present Hepatitis B Virus Infection

Padovan

Filippini

Tincani

et al. 2016

Arthritis Care & Research

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Objective. Rheumatoid arthritis (RA) with concomitant hepatitis B virus (HBV) infection represents a therapeutic challenge due to the risk of HBV reactivation under immunosuppressive treatment. To date there are few data coming from anecdotal case reports that concern HBV reactivation following treatment with abatacept. This observational retrospective study was aimed to assess the safety profile of abatacept in this particular clinical setting. Methods. Eleven Italian rheumatologic centers provided data from patients with RA and positive HBV serology treated with intravenous abatacept. HBV markers and clinical and laboratory data were checked at followup visits every 3 months. Results. In total, 72 patients were included in the study: 47 inactive carriers, 21 occult carriers, and 4 chronic active carriers for HBV. At baseline all of the patients had normal liver function tests and low or undetectable HBV DNA levels, except for those with chronic active hepatitis. Thirteen patients received prophylaxis with lamivudine, and 4 received treatment with adefovir or tenofovir. At the end of the 24-month followup period, 49 patients were being treated. Data from 316 followup visits showed that abatacept was safe. No patients experienced reactivation of hepatitis B. Treatment withdrawals (23 patients) were due to lack of efficacy, subject decision/lost at followup, or adverse events not related to HBV infection. Conclusion. Our study provides reassuring data about the safety profile of abatacept in RA with concomitant HBV infection without universal antiviral prophylaxis. Further prospective studies are needed to confirm these preliminary results.

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TNF alpha antagonist therapy and safety monitoring

Cited by 65 publications

References 437 publications

Improvement in Safety Monitoring of Biologic Response Modifiers After the Implementation of Clinical Care Guidelines by a Specialty Pharmacy Service in an Academic Health System

Improvement in Safety Monitoring of Biologic Response Modifiers After the Implementation of Clinical Care Guidelines by a Specialty Pharmacy Service in an Academic Health System

Biological Treatment of Crohn’s Disease

Safety of Abatacept in Rheumatoid Arthritis With Serologic Evidence of Past or Present Hepatitis B Virus Infection

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