New Report Warns of Blood Disorders and TB from Some Rheumatoid Arthritis Drugs

Friday, August 21, 2015
Arthritis

Rheumatoid arthritis is a chronic disease of the immune system that affects nearly 1% of all adults with painful joints. Since its effects are best managed with medication, this has netted a multi-billion dollar segment for drug manufacturers.

However, a new report shows the growth of these drugs may present a whole new risk of side effects, including blood disorders and tuberculosis.

The medications used to treat rheumatoid arthritis typically fall into one of 4 categories: disease-modifying anti-rheumatic drugs (DMARDs), glucocorticoids, non-steroidal anti-inflammatory medications (NSAIDs) and analgesics (painkillers).

Disease-modifying anti-rheumatic drugs are often the first line of defense for those diagnosed with RA. They are used in conjunction with other meds to disrupt the part of the immune system that causes inflammation. Some DMARDS, known as TNF-alpha drugs, inhibit the tumor necrosis factor, while others do not.

A recent review of FDA adverse event filings by the independent firm Adverse Events found an elevated level of complaints for both TNF-alpha drugs, such as Cimzia, Simponi, Humera, Enbrel and Remicade, as well as non-TNF alphas, like Imuran, Arava, Rituxan and Orencia.

However, where the non-TNF alphas registered higher for a certain blood disorder, the TNF-alphas had slightly more complaints for respiratory infections.

 

Blood Disorders and Infections Linked to Rheumatoid Arthritis Drugs

In all, the review flagged four out of the six non-TNF alphas as having higher FDA reports for the blood disorder pancytopenia. This condition is characterized by a drop in red and white blood cells, as well as platelet count.

Over 150 reports of pancytopenia were linked to the drug Arava, while 360 patients complained of the blood disorder while taking Rituxan. TNF-alpha inhibitors like Cimzia and Simponi, on the other hand, posted only 13 and 22 cases each, respectively, for pancytopenia.

Since DMARDS are designed to target the immune system, it’s no surprise they may also come with infection side effects. However, the report still arose some alarm.

Rituxan, for example, produced 670 reports of sepsis infection, while Arava had 172, Cimzia had 126, Simponi had 95 and Imuran had 93.

 

Respiratory Infections Linked to RA Meds

When the data was examined for respiratory infections, it was the TNF-alphas that had significantly higher rates of FDA complaints.

The blockbuster drug Enbrel was listed in 3,372 adverse event reports for upper respiratory infection, while Humira was named in 1,657. The highest number of respiratory infections for non-TNF alphas, however, was only 84 for the drug Orencia.

The most unexpected data, however, according to AdverseEvents’ VP Keith Hoffman, was the rising number of tuberculosis cases associated with the DMARD meds. In total, 9 out of the 11 drugs reviewed had at least one report of a patient developing TB.

The highest of these was the drug Remicade, with 1,607 FDA reports linked to tuberculosis. Enbrel was next with 508 TB reports.

Check back for more from DrugNews on the continuing studies and FDA reports associated with rheumatoid arthritis medications.

 

Sources:

Wasserman, E. AdverseEvents flags TB reports, blood-disorder cases linked to RA drugs. FiercePharma. (June 30, 2015). Retrieved from www.fiercepharma.com

Rheumatoid Arthritis Medications: An Analysis Utilizing AdverseEvents Explorer. Advara Health. Retrieved from www.info.adverahealth.com

Arthritis
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Arthritis
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