Medications for serious or life-threatening conditions may receive accelerated approval from the U.S. Food and Drug Administration (FDA) by showing an effect on surrogate measures that are reasonably likely to predict a treatment’s clinical benefit. Post-approval confirmatory drug trials are then required to determine whether or not these effects translate into clinical improvements. In recent…
(Reuters)—Johnson & Johnson’s blockbuster psoriasis drug ustekinumab (Stelara) led to a significant reduction in disease activity in patients with systemic lupus compared with a placebo in a midstage clinical trial, according to data released on Nov. 4. Ustekinumab is already approved for psoriasis, psoriatic arthritis and Crohn’s disease and had third-quarter sales of $1.12 billion….
FDA Approves Adalimumab-adbm On Aug. 29, the FDA approved Cyltezo (adalimumab-adbm), a biosimilar to Humira (adalimumab).1 Cyltezo was approved as a prefilled syringe to treat multiple chronic inflammatory diseases, including moderate to severe active RA, active psoriatic arthritis and ankylosing spondylitis, and moderate to severe plaque psoriasis. The treatment has also been approved for moderate…
Systemic sclerosis (SSc), a subtype of scleroderma, is a rare, complex autoimmune disease characterized by widespread vasculopathy of the small arteries and fibroblast dysfunction.1,2 It has been described as a fibrosing microÂvascular disease, because vascular injury precedes and leads to tissue fibrosis.3 The resulting Raynaud’s phenomenon, pain, skin thickening and tightening, and multi-organ involvement have…
In an extension study, nearly half the patients with plaque psoriasis taking secukinumab maintained skin clearance for the five years of the study…
MADRID—Researchers say that whole-body MRI could yield an earlier diagnosis of spondyloarthropathy (SpA) in patients with early inflammatory joint symptoms, according to findings presented in a poster session at the Annual European Congress of Rheumatology (EULAR). The approach could lead to earlier treatment and better outcomes, they say. Investigators at the University of Leeds recruited…
Wider awareness and understanding of the more than 100 different rheumatic diseases is a vital element in our work as rheumatologists and rheumatology health professionals. Stimulating interest and engagement among lawmakers, patient groups and the public at large is essential to successful advocacy efforts, as well as the overall future of our specialty. This September,…
The FDA has approved adalimumab-adbm, a biosimilar, to treat multiple chronic inflammatory diseases…
This month, the National Psoriasis Foundation is urging patients and rheumatologists to take charge of psoriatic disease by setting ambitious treatment goals to achieve better health outcomes…
Despite the innovations of new biologics and disease-modifying anti-rheumatic drugs, a large unmet need remains for patients with rheumatic autoimmune disease. Treatment remains limited for many conditions, including for conditions with a dim prognosis, such as systemic sclerosis.1 One promising treatment avenue is hematopoietic stem-cell transplantation (HSCT). Here, we provide background on HSCT for severe…