FDA approves new treatment option for RA
 
The FDA approved tofacitinib citrate (Xeljanz; Pfizer) on November 6 for the treatment of moderate to severe active rheumatoid arthritis (RA). Tofacitinib is approved for use in adults with RA who have not responded adequately to methotrexate.
 
The recommended dose is 5 mg PO twice daily. Tofacitinib may be used as monotherapy for RA; it may also be combined with methotrexate or with other nonbiologic disease-modifying antirheumatic drugs (DMARDs). It should not be used in combination with biologic DMARDs or with immunosuppressants such as azathioprine and cyclosporine.
 
Tofacitinib works by blocking Janus kinase (JAK) molecules, which are important in the joint inflammation of RA. It is the first drug of this class to target RA.
 
The prescribing information for tofacitinib includes a boxed warning of the drug’s safety risks, which include serious bacterial, invasive fungal, viral, and other opportunistic infections; tuberculosis; lymphoma; and other malignancies.
 
Higher cholesterol levels, increased liver enzyme levels, and decreased blood cell counts have been seen in patients taking tofacitinib.
 
In clinical trials, the most common adverse reactions to tofacitinib were upper respiratory infections, headache, diarrhea, and nasopharyngitis.
 
A postmarketing study will be conducted to evaluate the long-term effects of tofacitinib on cardiac disease, cancer, and serious infections.
 
 
Cochrane analysis: Topical NSAIDs effective for chronic musculoskeletal pain
 
A recent Cochrane review affirms that topical nonsteroidal anti-inflammatory drugs (NSAIDs) are effective for chronic musculoskeletal pain in adults.
 
Sheena Derry, PhD, of the University of Oxford’s Pain Research and Nuffield Department of Clinical Neurosciences, Oxford, UK, and associates searched electronic databases, clinical trial registers, and topical NSAID manufacturers’ databases for high-quality studies of topical NSAIDs used to treat chronic musculoskeletal pain. They looked at randomized, double-blind studies that included placebo or active comparators where at least one treatment was a topical NSAID formulation (cream, gel, patch, solution). They looked at studies that were at least 8 weeks long.
 
After analyzing data from 34 studies that included 7688 participants, Derry and colleagues found that:

• Topical NSAIDs were significantly more effective than placebo in reducing chronic musculoskeletal pain.
• The number-needed-to-treat (NNT) to achieve at least 50% pain relief for osteoarthritis over an 8- to 12-week period was 6.4 for diclofenac solution and 11 for diclofenac gel.
• No difference in efficacy was shown in a direct comparison of topical NSAIDs with oral NSAIDs.
• Local adverse events, such as skin reactions, were increased with topical NSAIDs compared with placebo or oral formulations, but no increase in serious adverse events was seen.
• Gastrointestinal adverse events with topical NSAIDs occurred at the same rate as with placebo, and less frequently than with oral NSAIDs.

 
For an abstract of the Cochrane review, go to: Derry S, Moore RA, Rabbie R. Cochrane Database Syst Rev. Sept 12, 2012; issue 9.