guselkumab

The interleukin-23 blocker guselkumab (Tremfya) continues to show promise in treating Crohn’s disease (CD). First winning FDA approval for plaque psoriasis in 2017, guselkumab recently demonstrated robust efficacy and a consistent safety profile in the long-term extension of the GALAXI Phase 2 study for CD. Some 54.1% of patients receiving guselkumab achieved clinical remission by…

Janssen continues to strengthen the case that its interleukin-23 inhibitor TREMFYA (guselkumab) offers promise to many patients with psoriatic arthritis (PsA). The company’s phase 3b COSMOS clinical trial involving 189 patients with active PsA and an inadequate response to one to two previous tumor necrosis factor (TNF) inhibitors, guselkumab showed sustained improvements in measures of…

Data from Janssen’s phase 3b COSMOS clinical trial reveals that guselkumab (Tremfya), an inhibitor of interleukin-23 (IL-23), provides improvements in all minimal disease activity (MDA) domains for adults with active psoriatic arthritis (PsA). The benefits persist through week 48, even in patients who have seen inadequate responses to one or two tumor necrosis factor inhibitors…

At the American College of Rheumatology (ACR) meeting, Janssen Immunology presented a Tremfya (guselkumab) posthoc analysis demonstrating stringent disease activity control at two years in patients with psoriatic arthritis. In addition, the analysis of Phase 3 DISCOVER-2 data indicated that patients with active psoriatic arthritis with a response at week eight to the IL-23 inhibitor…

Janssen (NYSE:JNJ) has announced positive data from the first randomized controlled trial to test the safety and efficacy of combination therapy with an interleukin (IL)-23p19 subunit antagonist (guselkumab) and a tumor necrosis factor-alpha (TNFα) antagonist (golimumab) in ulcerative colitis. In the Phase 2a VEGA study, 48% of patients who received combination induction therapy with guselkumab and…

Johnson & Johnson’s Janssen subsidiary has released positive data from an ongoing analysis of the Phase 2a VEGA clinical study of guselkumab and golimumab. The trial focused on adults with moderately to severely active ulcerative colitis (UC). The study tested the efficacy of 12 weeks of combination induction therapy with the interleukin-23 subunit p19 inhibitor…

Janssen (NYSE:JNJ) has released new data showing the efficacy of the IL-23 inhibitor Tremfya (guselkumab) for a variety of psoriatic arthritis (PsA) symptoms for up to two years. Patients with active psoriatic arthritis treated with guselkumab in Phase 3 studies had consistent, long-term efficacy over two years. Specifically, patients who received the drug had improvements…

Johnson & Johnson’s (NYSE:JNJ) Janssen unit announced new Phase 2 GALAXI 1 data at Digestive Disease Week (DDW), showing substantial rates of clinical-biomarker and endoscopic response and clinical remission through 48 weeks of Tremfya (guselkumab) therapy for Crohn’s disease. The company also announced long-term pooled safety analyses for Stelara (ustekinumab) at the DDW event May…

Tens of millions of Americans have immune-mediated inflammatory diseases (IMIDs), including conditions as diverse as rheumatoid arthritis, psoriasis, multiple sclerosis and inflammatory bowel disease. Because such diseases have an inflammatory component, a single biologic could treat multiple IMIDs. “We are committed to investigating inflammatory pathways to develop therapies that can potentially address the immense unmet…

A recent comprehensive network meta-analysis (NMA) concluded that Tremfya (guselkumab) from Janssen (NYSE:JNJ) ranked highest for the overall level of skin clearance among 23 treatment regimens for active psoriatic arthritis (PsA). The NMA drew on data from 33 Phase 3 randomized clinical trials. Of those, 15 were targeted PsA therapies such as the IL-23p19 inhibitors such…

Psoriatic arthritis (PsA) is a complex heterogeneous disease involving the peripheral joints, affecting between 7% and 26% of psoriasis patients. Among the popular treatment options for psoriasis are tumor necrosis factor (TNF) inhibitors. A significant portion of psoriatic arthritis patients, however, fail to respond to TNF inhibitors.  Janssen announced last month that Tremfya (guselkumab) fared…

Eli Lilly and Company (NYSE:LLY) announced that its interleukin-23 subunit p19 inhibitor mirikizumab achieved its primary endpoint of clinical remission at 52 weeks in the Phase 3 LUCENT-2 study. Lilly says mirikizumab is the first anti-IL23p19 to demonstrate maintenance of clinical remission in a Phase 3 ulcerative colitis study. Janssen (NYSE:JNJ) has ongoing clinical trials…

Johnson & Johnson’s Janssen division (NYSE:JNJ) has released topline results from the Phase 2 GALAXI 1 clinical study testing the potential of TREMFYA (guselkumab) in patients with moderately to severely active Crohn’s disease (CD). The study found that nearly two-thirds (65%) of TREMFYA (guselkumab) recipients achieved clinical remission at week 48. The trial used the…

Janssen (NYSE:JNJ) recently presented new data on Tremfya (guselkumab) related to active psoriatic arthritis (PsA) at the American College of Rheumatology (ACR) Convergence while also publishing data in Arthritis & Rheumatology. Notably, guselkumab provided durable joint symptom and disease activity improvement with a consistent safety profile through week 100 in adults with active psoriatic arthritis (PsA).…

Janssen’s Tremfya (guselkumab) generally had higher efficacy in treating moderate-to-severe psoriasis than Cosentyx (secukinumab) from Novartis, according to recent data published in the Journal of Dermatological Treatment.  In the 48-week Phase 3 ECLIPSE study, a greater number of guselkumab recipients achieved at least a 90% and 100% improvement from baseline in Psoriasis Area and Severity…

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…

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…

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…

Johnson & Johnson’s (NYSE:JNJ) pharmaceutical subsidiary Janssen has announced that its Tremfya (guselkumab) selective interleukin (IL)-23 inhibitor therapy led to durable, complete skin clearance in the majority of adults with moderate-to-severe plaque psoriasis (PsO) for up to five years. The drug also showed substantial efficacy in treating active psoriatic arthritis (PsA) for up to one…