Rheumatology

AbbVie (NYSE:ABBV) announced that the interleukin-23 antagonist Skyrizi (risankizumab) had received backing from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) to treat active psoriatic arthritis. The committee recommended the drug for adults with active psoriatic arthritis who have had an inadequate response or who have been intolerant to one…

AbbVie (NYSE:ABBV) has announced positive top-line results in a Phase 3 trial focusing on patients with active ankylosing spondylitis (AS), an inflammatory disease that can eventually lead to fused vertebrae. The first of two studies, the SELECT-AXIS 2 study examined a daily 15-mg dose of Rinvoq (upadacitinib) in AS patients who had an inadequate response…

Janssen’s Stelara (ustekinumab) was associated with a rate of safety events similar to that of placebo during the control phase of a range of clinical trials. The Johnson & Johnson (NYSE:JNJ) subsidiary shared the data related to adults 60 and older at the virtual United European Gastroenterology Week (UEGW). The study pooled safety data from…

A post-hoc analysis published in Lancet Rheumatology suggested that Janssen’s IL-23 inhibitor Tremfya ​​(guselkumab) is effective in treating psoriatic arthritis (PsA) patients with symptoms affecting the spine and sacroiliac (SI) joints. In addition, the patient subset had sustained improvement through 52 weeks. The study focused on psoriatic arthritis patients in the company’s Phase 3 DISCOVER-1 and DISCOVER-2…

Janssen’s Tremfya (guselkumab) was associated with reduced fatigue in two Phase 3 clinical trials involving 1,120 patients with psoriatic arthritis (PsA), according to an article published in Arthritis Research & Therapy. The study found that PsA patients who received 100 mg of guselkumab every four weeks or every eight weeks had clinically meaningful and sustained improvements…

The Galien Foundation has revealed its latest nominees for the 2021 Prix Galien USA Award highlighting innovations in biotechnology, pharmaceutical agents, medical technology and digital health products. Entrants to the competition must have received FDA approval within the past five years and demonstrate exceptional therapeutic potential. The Galien Foundation does not use financial data to…

FDA has indicated Lilly‘s OLUMIANT (baricitinib) to treat adult patients with moderately to severely active rheumatoid arthritis. In particular, the agency has recommended the drug for patients with an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies. In June, Lilly and its partner Incyte announced that the drug appeared to reduce…

The Janus kinase (JAK) inhibitor Rinvoq (upadacitinib) from AbbVie has a current indication for moderate to severe active rheumatoid arthritis for patients with an inadequate response or intolerance to the immunosuppressant methotrexate. Rinvoq is seeking expanded approval for the drug to treat moderate to severe atopic dermatitis (AD), which is a form of eczema. Earlier this…

Two decades ago, psoriasis was a poorly understood condition. Treatment options for severe psoriasis included powerful immunosuppressant agents such as methotrexate and cyclosporin that can have significant side effects. But the fact those immunosuppressant drugs were effective at treating psoriasis helped pave the way to use biologics to treat the condition. The experience “really taught…

In the past half-century, scores of investigational drugs for lupus have seemingly failed in clinical trials. GSK’s Benlysta (belimumab) is unique in winning approval from the FDA and European regulatory authorities. Anifrolumab from AstraZeneca, which would be a first-in-class type I interferon inhibitor, is one of the most promising investigational drugs for treating systemic lupus…

A recent post hoc analysis from AstraZeneca (LON:AZN) found that the monoclonal antibody anifrolumab (Saphnelo) led to consistent improvements in skin rash and arthritis in patients with systemic lupus erythematosus (SLE), which is the most common lupus type. A pooled analysis of the Phase 3 TULIP-1 and TULIP-2 clinical trials investigating anifrolumab showed the drug led…

AstraZeneca (LON:AZN) has announced that a new posthoc analysis of data from the TULIP Phase 3 clinical trials of anifrolumab showed promise in patients with systemic lupus erythematosus (SLE), the most common type of lupus. Anifrolumab is a monoclonal antibody that blocks the activity of interferons such as interferon-α and interferon-β. If approved, anifrolumab would be…

Eli Lilly and Company (NYSE:LLY) has announced that recent Phase 3 data suggest Taltz (ixekizumab) was effective in the long-term management of axial spondyloarthritis (axSpA). Taltz, an interleukin-17A antagonist, is currently indicated for plaque psoriasis, psoriatic arthritis and active ankylosing spondylitis. In the COAST-Y study, Taltz demonstrated long-term improvements in patients’ symptoms with the two subtypes of…

The Janssen division of Johnson & Johnson (NYSE:JNJ) has announced that its selective IL-23 inhibitor Tremfya (guselkumab) led to joint symptom improvement and skin clearance in the majority of patients with an inadequate response to tumor necrosis factor inhibitors (TNFi’s). After 24 weeks of treatment, 44.4% of patients who received Tremfya had at least a…