PDSA E-News: November 28, 2016




Inactivated Flu Vaccine Can Cause Recurrent ITP

Flu shotPhysicians at the Sackler School of Medicine in Tel Aviv, Israel, have reported a case of recurrent ITP believed to have been generated by the influenza trivalent inactivated vaccine. The 4 ½ year-old patient was brought to the medical center with mucosal bleeding, bruises, and petechiae a week after receiving the vaccine. A complete blood count (CBC) test showed a decreased platelet count, which returned to normal 10 days after receiving a single dose of IVIg.

The patient’s medical history indicated two prior hospitalizations with similar symptoms, both within one week of immunization with the same inactivated influenza vaccine. Physicians noted that the patient did not experience any bleeding symptoms during the year that he was not vaccinated. The medical team advised against further vaccination with the inactivated vaccine. They have reported that this case is the first in which the influenza vaccine is the cause of ITP in a pediatric patient.

ITP patients who plan to receive a flu shot should take into consideration both that this case is currently the only one known that has caused this reaction, as well as the fact that the child received an inactivated (killed) vaccine in contrast with an attenuated (live) vaccine, which could have produced different results. Conversely, it is also important to note that PDSA medical advisors have suggested that contracting the flu itself can result in lowered platelet counts or relapsed ITP. Patients should discuss with their hematologist before making a decision.

Monthly Prescribing Reference. “Case: Recurrent Immune Thrombocytopenia after Flu Shot.” MPR. 11/9/2016.



Decreased Vitamin D3 Levels Found in Patients with Active ITP

A recent study published in Molecular Immunology showed that patients with active immune thrombocytopenia (ITP) had decreased Vitamin D3 levels. The findings indicated that Vitamin D3 may play a role in developing ITP, an acquired autoimmune disease. Both 1α, 25-dihydroxyvitamin D3 [1, 25(OH)₂D₃] and vitamin D receptor (VDR) play important immune-suppressive roles in the immune system. In this study, Chinese researchers evaluated both D3 and VDR mRNA expression levels and determined whether the D3/VDR were correlated with T cell dysfunction in ITP patients. The researchers found D3 levels were decreased in active ITP patients and that D3 had significant anti-inflammatory effects on patients with ITP. They found D3 suppressed pro-inflammatory cytokines (INF-ƴ and IL-17A) but promoted anti-inflammatory cytokine (IL-10). They concluded that decreased 1, 25(OH)₂D₃ /VDR might be part of the development of ITP and that appropriate supplementation with D3 might be a promising treatment.

Vitamin D3 research has shown D3 deficiency is associated with increased autoimmunity and increased susceptibility to infection. Lab tests measure blood levels of vitamin D in nanograms per milliliter (ng/mL) or nanomoles per liter (nmol/L) of 25-hydroxyvitamin D, with 1 ng/mL equaling 2.5. Many vitamin D researchers and experts have argued a blood level of at least 30 ng/mL is optimal; others advise higher levels— 40 or 50 ng/mL. It is important for ITP patients to know their Vitamin D3 levels, to discuss testing with their doctor, and if found below optimal range, to supplement with D3.

Liu W, Li H, Hao Y, et al. “Decreased immunosuppressive actions of 1α, 25-dihydroxyvitamin D3 in patients with immune thrombocytopenia.” Molecular Immunology, 2016 Oct; 78: 89-97. Doi: 10.1016/j.molimm.2016.08.014. Epub 2-16 Sep 7.



Rigel’s Phase 3 Studies of Fostamatinib Showed Benefit in ITP Patients

Rigel logoIn October Rigel Pharmaceuticals announced results for the second of two double-blind studies in its FIT Phase 3 clinical trials for fostamatinib, an oral spleen tyrosine kinase (SYK) inhibitor for patients with chronic/persistent ITP. SYK kinase is a key player in the immune process that causes platelet destruction in ITP. Primary endpoint of the study was a stable platelet response (defined as a 50,000 or higher platelet count on at least four of the last six clinic visits between weeks 14 and 24 of treatment), which was reported for 17% of patients receiving fostamatinib. In the earlier FIT 2 Phase 3 study, response rate to fostamatinib was 18%.

In the FIT 2 Phase 3 study one patient in the placebo group achieved a stable platelet response. Because the difference between patients on treatment and those on placebo did not reach statistical significance, the FIT 3 Phase 3 study did not meet its primary endpoint. However, when data from the FIT 3 Phase 3 and FIT 2 Phase 3 studies were combined, the differences were statistically significant. Data from both Phase 3 studies plus an open-label extension study, demonstrated consistent benefit of fostamatinib in ITP. Raul Rodriguez, President and CEO of Rigel, said, “We are encouraged by these results and believe that the risk/benefit ratio for fostamatinib is positive for patients with chronic/persistent ITP, a population with a serious unmet medical need.” He said Rigel would continue to pursue this opportunity and seek feedback from the US FDA.

“Rigel Announces Results from the Second FIT Phase 3 Study and the Long-Term Open-Label Extension Study for Fostamatinib in ITP.” PR Newswire, Oct. 20, 2016; information provided by Rigel Pharmaceuticals, Inc.



Modified CMS P-Code Allows Outpatient Billing of Platelet Safety Test and Extends Platelet Shelf-life from 5 to 7 Days

TransfusionGood news for patients who sometimes receive platelet transfusions. A modified CMS P-Code may make platelets safer, extend the lifespan of platelets for transfusion, and save millions of healthcare dollars. November 1, 2016 the US Centers for Medicare and Medicaid Services (CMS) issued a permanent Healthcare Common Procedure Coding System (HCPCS) Level II code. The modified P code allows medical facilities running Verax Biomedical Platelet PGD® tests to code and bill for Medicare hospital outpatient reimbursement of platelet components tested with PGD®. The CMS revised the HCPCS Code (established in 2016) for pathogen-reduced platelets (P9072) to include use of pathogen-reducing technology or rapid bacterial testing.

CMS establishing a permanent P-code signifies the importance of this testing for safety of the nation’s blood supply and provides a pathway for reimbursement for rapid testing. The Verax Platelet PGD® Test was FDA cleared for detecting bacterial contamination in platelets. It is the only FDA-cleared method to extend platelet lifespan from 5 days to 7 days. Expiration of 5-day platelets currently costs the US health system more than $150 Million per year. Extending the platelet lifespan to 7 days will offer considerable cost savings to hospitals and blood banks as well as extend an important life-saving resource.

“CMS Modifies Permanent P-Code Allowing Outpatient Hospital Billing of the Verax PGD® Test.” Business Wire, Nov. 15, 2016.




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