The approval was supported by a clinical program that included dose-ranging trials (Study I and II) and confirmatory Phase 3 trials (Study III and IV).
Offspring were followed from birth until 12 months, first indication of serious infection, end of commercial insurance eligibility, death or end of study period, whichever came first.
The panel's decision was based on four Phase 3 studies which evaluated the impact of baricitinib on RA signs and symptoms, physical function, joint damage progression and other patient-reported outcomes.
The randomized, double-blind, controlled trial (N=24,081) included patients with rheumatoid arthritis or osteoarthritis who required chronic NSAID treatment.
At week 12, results showed 71% in the upadacitinib group had achieved ACR20, compared to 63% and 36% in the adalimumab and placebo groups, respectively.
Data added to the labeling includes first-of-their-kind pharmacokinetic studies demonstrating negligible to low transfer of CIMZIA through placenta and minimal transfer to breast milk from mother to infant.
The use of angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs) was associated with a reduced risk of myocardial infarction (MI) among patients with rheumatoid arthritis (RA).
Specific foods that were highlighted include dried plums, blueberries, pomegranates, whole grains, ginger, turmeric, specific oils, and teas; these foods were found to reduce inflammatory cytokines, joint stiffness, pain, and oxidative stress.
The FDA's expanded approvals were supported by data from two Phase 3 multicenter, randomized, double-blind, placebo-controlled studies (GO-VIBRANT and GO-ALIVE) that included >600 patients.
Sirukumab, a human monoclonal IgG1 kappa antibody, works differently than current IL-6 inhibitors approved to treat RA by targeting the IL-6 cytokine vs. the IL-6 receptor.
Tofacitinib plus MTX was shown to be non-inferiority vs. adalimumab plus MTX, however, Xeljanz monotherapy did not meet its primary endpoint for non-inferiority vs.adalimumab plus MTX, or vs. Xeljanz plus MTX.
Some children born to mothers with rheumatoid arthritis (RA) may have higher-than-average odds of developing epilepsy, according to a study published online in Neurology.
Tobacco smoking adversely impacts rheumatoid arthritis (RA) flare and remission rates, according to findings from a long-term retrospective, population-based cohort study, presented at the 2016 ACR/ARHP Annual Meeting.
Temporarily discontinuing methotrexate (MTX) treatment can improve seasonal influenza vaccination immunogenicity among patients with rheumatoid arthritis (RA), according to a single center, randomized, single-blind, open-label prospective study (NCT02748785) presented at the 2016 ACR/ARHP Annual Meeting.
Results from a global survey given to patients and physicians showed that good communication is "critical to achieve optimal care".
The IL-6Rα -targeting human mAb sarilumab offers durable responses against rheumatoid arthritis (RA), according to an analysis of 3-year clinical and radiographic outcomes and safety for patients from the MOBILITY open-label extension study.
The IL-6Rα -targeting human mAb sarilumab exhibits comparable efficacy and safety for different patient subgroups in rheumatoid arthritis.
A new review has found disease-modifying anti-rheumatic drugs (DMARDs) to be effective in halting progressive bone loss in rheumatoid arthritis (RA) patients, and suggests that they should be used early in treatment.
Eli Lilly and Incyte announced positive data from the pivotal study, RA-BEYOND, evaluating baricitinib vs. placebo for the treatment of rheumatoid arthritis (RA). Study findings were presented at the Annual European Congress of Rheumatology (EULAR 2016) in London.
For patients with rheumatoid arthritis (RA) and a first non-tumor necrosis factor inhibitor (TNFi) failure, treatment with tocilizumab seems more efficacious than abatacept or rituximab
Patients with rheumatoid arthritis (RA) have increased herpes zoster (HZ) risk with older age and higher prednisone dose, according to a study published in Arthritis Care & Research.
Patients with rheumatoid arthritis (RA) have lower disease activity when seen at practices with nurse practitioners (NPs) or physician assistants (PAs) versus rheumatologist-only practices, according to a study published in Arthritis Care & Research.