Category Archives: Rheumatology

Golimumab (Simponi) side effects: risk of serious fungal infections

Centocor Ortho Biotech and FDA reminded prescribers of the risk of serious fungal infections associated with TNF-α blockers, this includes the newer Simponi (golimumab).

Simponi is a recently approved human monoclonal antibody for the treatment of rheumatic diseases. Its indications include:

  • Moderately to severely active Rheumatoid Arthritis (RA) in adults, in combination with methotrexate.
  • Active Psoriatic Arthritis (PsA) in adults, alone or in combination with methotrexate.
  • Active Ankylosing Spondylitis in adults (AS).

According to the FDA, histoplasmosis and other invasive fungal infections are not consistently recognized in patients under other TNF-α blockers such as Cimzia (certolizumab pegol), Enbrel (etanercept), Humira (adalimumab), and Remicade (infliximab). This has resulted in delays in appropriate antifungal treatment, which in some cases has lead to death. The agency also added  a Boxed Warning to this group of medications,  alerting about an increased risk of  lymphoma.

Also, the UK’s National Institute for Health and Clinical Excellence (NICE) issued in February 2009 an update of the rheumatoid arthritis clinical guidelines.


MedWatch: The FDA Safety Information and Adverse Event Reporting Program. Simponi (golimumab)

Video lecture: Biologic therapies for inflammatory and autoimmune diseases

Dr. Chan explains how biologic therapy (mainly through monoclonal antibodies) is changing the present and future of autoimmune and inflammatory diseases. He illustrates some examples of autoimmune diseases such as: multiple sclerosis, asthma, treatment of rheumatoid arthritis with etanercept, and others.Continue Reading

Overview on monoclonal antibody therapy: PPT, images and videos

This post intends to be a brief and readable overview on what monoclonal antibodies (mAbs) are and some examples of their clinical applications. The following slideshow is a clear and accurate introduction on the topic: (ignore the first slide error message and move to the second)Continue Reading

More evidence that bisphosphonates do not increase the risk of atrial fibrillation (AF) or flutter

Bisphosphonates don’t increase the risk of atrial fibrillation, according to the study Oral Bisphosphonates and Risk of Atrial Fibrillation and Flutter in Women: A Self-Controlled Case-Series Safety, published in PLoS One on March 2009. The authors used a self-control case series analysis to study nearly 400,000 women from the UK General Practice Research Database. They…

New 2009 NICE clinical guideline for the treatment of rheumatoid arthritis

The UK’s National Institute for Health and Clinical Excellence (NICE) issued in February 2009 an update of the rheumatoid arthritis guideline. Pharmacist Matt Robinson at his excellent “Prescribing advice for GP’s” commented the most relevant points of the guidance: This guideline recommends that treatment is started early during active disease in order to minimise damage…

Scottish Medicines Consortium accepted Adalimumab (Humira) for adolescents that do not respond to other DMARDs

An excerpt from the Drug Advice issued by the Scottish Medicines Consortium on adalimumab (Humira): adalimumab (Humira)  is  accepted  for  restricted  use  in  NHS  Scotland,  in  combination  with methotrexate, for the treatment of active polyarticular juvenile idiopathic arthritis in adolescents aged 13-17  years  who  have  an  inadequate  response  to  one  or more  disease-modifying  anti-rheumatic drugs…

Cochrane review: Anakinra (Kineret) for reumathoid arthritis has modest efficacy

A recent Cochrane review about the use of anakinra (Kineret) for reumathoid arthritis, concludes that it is a “modestly efficacious biologic therapy for rheumatoid arthritis”. Authors’ conclusions Anakinra is a relatively safe and modestly efficacious biologic therapy for rheumatoid arthritis. Although head to head comparison trials have not been carried out, the amount of improvement…

Febuxostat (Adenuric, Ipsen) for the management of hyperuricemia in gout patients. NICE guidance

The following is an excerpt of the NICE guidance about: Febuxostat for the management of hyperuricaemia in people with gout. 1 Guidance 1.1 Febuxostat, within its marketing authorisation, is recommended as an option for the management of chronic hyperuricaemia in gout only for people who are intolerant of allopurinol (as defined in section 1.2) or…Continue Reading

Efalizumab (Raptiva) and progressive multifocal leukoencephalopathy (PML). New safety information

This is duplicated text of a letter from EMD Serono Canada Inc to health care professionals, available at Health Canada . Dear Health Care Professional, EMD Serono Canada Inc., in collaboration with Health Canada, would like to inform you of important new safety information regarding the risk of serious infections, including progressive multifocal leukoencephalopathy (PML),…Continue Reading

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