Data from a Phase 2 trial of baricitinib for the treatment of SLE supporting the Fast Track designation were published in The Lancet and presented at the European Congress of Rheumatology earlier this year.
The designation was granted to Revive Therapeutics, a company that specializes in cannabis-based pharmaceuticals.
Patients with SLE who experienced high pain levels and had a visit to the emergency department the previous year were more likely to use opioids.
The sNDA included data from the REACH1 study (N=71) which evaluated ruxolitinib in combination with corticosteroids in patients with steroid-refractory acute GVHD.
Experts at the 2018 ACR/ARHP Annual Meeting discuss whether hydroxychloroquine dosing should be more than 5 mg/kg in patients with systemic lupus erythematosus.
The approval for follow up treatment was based on data from an open-label, prospective, active-controlled study (MAINRITSAN) involving 115 patients in disease remission (86 with GPA, 24 with MPA, 5 with renal-limited ANCA-associated vasculitis)
Gammaplex, an immune globulin, is indicated to treat chronic immune thrombocytopenic purpura (ITP) and primary humoral immunodeficiency.
Of the 5256 patients who received a renal transplant in the study window (1/1/1998 - 12/31/2017), 14 met inclusion criteria.
X4 Pharmaceuticals is developing the drug, which is currently in a Phase 2/3 clinical trial involving patients with WHIM syndrome.
Researchers found that a non-immunosuppressant drug originally designed to treat osteoporosis (WAY-316606) targeted the same mechanism by antagonizing SFRP1, and after treating hair follicles with WAY-316606 for 6 days, the authors found enhanced human hair growth.
For females between 5 and 64 years of age, SLE ranked among the top 20 leading causes of death; it ranked 10th for those aged 15 to 24 years, 14th for those aged 25 to 34 years and 35 to 44 years, and 15th for those aged 10 to 14 years.
Patients were randomized to weekly subcutaneous (SC) belimumab or placebo (248 and 108 patients, respectively), plus standard SLE therapy for 52 weeks. SLE Responder Index (SRI4) at week 52 was assessed as the primary end point.
Results from the Phase 3 trial showed that the Quantitative Myasthenia Gravis (QMG) score at baseline to day 14 changed from 6.4 to 6.7 in the amifampridine group vs. 5.6 to 7.9 for the placebo group.
The PATH study demonstrated that the percentage of patients experiencing CIDP relapse or withdrawal for any other reason during SCIg treatment was significantly lower with Hizentra
The disease can be life threatening. Phase 3 study results released last March demonstrated Rituxan substantialy improved pemphigus vulgaris remission rates and successful tapering.
For this review, researchers performed an extensive literature search for studies and cases where an adverse drug reaction occurred likely due to an interaction between an herbal and a prescribed medicine.
The elevated risk of developing CVD in the ITP cohort (adjusted incidence rate ratio [IRR], 1.38) remained even after a sensitivity analysis which included only incident cases of ITP.
Scleroderma patients treated with myeloablative autologous stem-cell transplantation experienced significantly higher rates of disease-free survival at 52 months post-treatment compared to those treated with cyclophosphamide.
EGPA (formerly known as Churg-Strauss syndrome) is a condition characterized by asthma, high levels of eosinophils (a type of white blood cell that helps fight infection), and inflammation of small- to medium-sized blood vessels.
The researchers found that among 495 patients with undetectable CMV DNA at randomization, fewer patients in the letermovir group had clinically significant CMV infection or were classified as having a primary end point event by week 24 after transplantation, compared with the placebo group.
Prevymis, a non-nucleoside CMV inhibitor (3,4 dihydro-quinazoline), inhibits viral replication through targeting the viral terminase complex.
Most patients were asymptomatic and the diagnosis was discovered in pursuit of other abnormal biochemical tests and imaging studies. In the majority of patients, alkaline phosphatase (ALP) and gamma-glutamyl transferase (GGT) were elevated (88 and 90%, respectively).
In the study, Actemra given weekly and bi-weekly combined with a 6-month glucocorticoid regimen, more effectively sustained remission through Week 52 than placebo combined with a 26-week steroid taper and a 52-week steroid taper.
Based on the lab findings, a clinical trial testing bestatin against lymphedema is underway, Dr. Stanley Rockson lead author of the research.