Highlights of 5 topline news stories from the FDA, CDC, and American College of Rheumatology-with real-world implications for primary care practice.
References:
1. American College of Rheumatology. Omega-3 and omega-6 fatty acid intake may affect lupus outcomes. November 4, 2017. Accessed January 25, 2018.2. US Food and Drug Administration. Potential Signals of Serious Risks/New Safety Information Identified from the FDA Adverse Event Reporting System (FAERS): July - September 2017. Accessed January 25, 2018.3. Hesselstrand R, Nagel J, Saxne T, et al. Immunogenicity and safety of pneumococcal vaccination in patients with systemic sclerosis. Rheumatology. 2018 Jan 8. doi: 10.1093/rheumatology/kex471.4. Pfizer. Pfizer Announces FDA Approval of XELJANZ® (tofacitinib) and XELJANZ® XR for the Treatment of Active Psoriatic Arthritis. December 14, 2017. Accessed January 25, 2018.5. Schwartz AM, Hinckley AF, Mead PS, et al. Surveillance for Lyme Disease - United States, 2008-2015. MMWR. 2017;66:1-12. Accessed January 25, 2018.
The results of a recent cross-sectional study were presented at the American College of Rheumatology/Association of Rheumatology Health Professionals Annual Meeting in November 2017.1 The researchers used a dietary questionnaire in 456 patients with systemic lupus erythematosus (SLE) in southeast Michigan
An increasing ratio of omega-6s (pro-inflammatory) to omega-3s (anti-inflammatory) was associated with decreased SLE activity. Higher intake of omega-3s was linked to significantly improved sleep quality; in addition, there was a trend toward decreased depressive symptoms and decreased fibromyalgia.
Four rheumatology drugs were on the FDA Watch List issued for July to September 2017: tocilizumab injection (Actemra); methotrexate injection USP/methotrexate oral solution (Xatmap); Rheumatrex (methotrexate sodium) tablets/methotrexate tablets, USP; obeticholic acid tablets (Ocaliva), for oral use.2
This prospective study included 32 patients with systemic sclerosis (SSc) who were not taking disease-modifying antirheumatic drugs (DMARDs), 12 patients with SSc who were taking synthetic DMARDs, and 49 healthy controls.3
Participants received pneumococcal conjugate vaccine (PCV13) or pneumococcal polysaccharide vaccine (PPV23). Four to six weeks later, antibody levels to pneumococcal polysaccharides 6B and 23F were measured.
A lower antibody response to 23F and lower post-vaccination antibody levels to both 6B and 23F were found in patients with SSc who were receiving DMARDs. The current recommendation for PCV13 followed by PPV23 may improve vaccine immunogenicity in immunosuppressed patients such as those with SSc.
In December 2017, the FDA approved Xeljanz (tofacitinib) and Xeljanz XR for adults with active psoriatic arthritis and inadequate response/intolerance to methotrexate and other DMARDs.4 Xeljanz is also approved in moderate to severe RA.
It is intended for use in combination with nonbiologic DMARDs. It is not intended for use with biologic DMARDs or potent immunosuppressants such as azathioprine or cyclosporine. The labeling carries a boxed warning for serious infections and malignancy.
In the CDC surveillance review for Lyme disease, 275,589 cases were reported from 2008 to 2015.5 It is now the most commonly reported vector-borne disease in the US. Cases are increasing in states that neighbor those with high incidence.
