guselkumab Archives - Medical Design Sourcing

Tremfya shows durable efficacy for psoriatic arthritis joint and axial symptoms

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 related to joint, skin, enthesitis, dactylitis, spinal pain and disease severity endpoints.

Janssen also noted that analyses of its clinical trial data revealed that guselkumab supported broad improvements in health-related quality of life (HRQoL), including metrics such as fatigue, pain and work productivity.

Janssen presented the data culled from the DISCOVER-1, DISCOVER-2, and COSMOS clinical trials at the 2022 Annual European Congress for Rheumatology (EULAR) meeting held June 1-4.

Data from the DISCOVER-2 study showed that patients who received guselkumab had improvement ac…

Janssen’s pathway strategy for immune-mediated inflammatory disease shows promise in gastroenterology

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 need for patients living with immune-mediated diseases,” said Dr. Jan Wehkamp, Janssen’s vice president, gastroenterology disease area leader.

And thus, a drug like Janssen’s Tremfya (guselkumab), which is now indicated to treat moderate-to-severe plaque psoriasis and psoriatic arthritis in adults, could find use in gastroenterological conditions such as Crohn’s disease (CD) or ulcerative colitis (UC).

Tremfya selectively blocks the p19 subunit of interleukin (IL)-23.

Lilly’s mirikizumab beats placebo in pivotal ulcerative colitis trial

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 testing its interleukin-23 subunit p19 inhibitor guselkumab (Tremfya) as an inflammatory bowel disease therapy. Studies are ongoing testing guselkumab for adults with moderately to severely active ulcerative colitis.

Participants in Lilly’s LUCENT-2 study were previously enrolled in a 12-week induction study known as LUCENT-1.

Subjects in LUCENT-2 were rerandomized to receive mirikizumab maintenance dosing.

Lilly notes that a statistically higher number of mirikizumab recipients achieved clinical remission at one year than placebo recipients.

“Bowel urgen…

Janssen shares positive Phase 2 Tremfya data in Crohn’s

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 Crohn’s Disease Activity Index [CDAI]<150) to verify that benchmark.

The study provided the first long-term data testing guselkumab as a potential CD treatment in the U.S.

Guslkumab selectively inhibits the p19 subunit of interleukin IL-23.

Guselkumab is now FDA approved for moderate-to-severe plaque psoriasis and active psoriatic arthritis, but not yet for Crohn’s disease.

Tremfya (guselkumab) won FDA approval for adult patients with active psoriatic arthritis in 2020.

The placebo-controlled double-blind stu…

Janssen upbeat about latest guselkumab data for patients with psoriatic arthritis

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).

Guselkumab first won FDA approval in 2017 for treating moderate-to-severe plaque psoriasis. The drug became the first interleukin (IL)-23 inhibitor to win an FDA indication for active PsA in 2020.

“We at Janssen are committed to this IL-23 pathway and understanding how it is driving disease,” said Dr. Alyssa Johnsen, vice president, rheumatology and maternal-fetal immunology disease area leader at Janssen. The pathway is “very important for psoriatic arthritis and psoriasis, and we continue to investigate where it might be able to help patients and add…

Tremfya bests Cosentyx in psoriasis study

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 Index (PASI 90 and PASI 100). Guselkumab recipients also had higher rates of clear or almost clear skin based on the Investigator’s Global Assessment scores of IGA 0 and IGA 0/1, respectively

The difference in performance between the two drugs was especially pronounced in patients weighing more than 100 kg (220 pounds). For instance, 62.3% of guselkumab recipients weighing 100–110 kg had IGA 0/1 responses at week 48, while 44.4% of secukinumab recipients did.

The findings are significant because people with psoriasis have a higher prevalence and incidence of obesity…

Janssen’s Tremfya shows promise in PsA patients with sacroiliitis

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 studies with axial symptoms and sacroiliitis, an inflammation of one or both of the sacroiliac joints connecting the pelvis to the spine.

Among patients with psoriatic arthritis, sacroiliitis is a relatively common condition. One small study found that 38% of PsA patients had sacroiliitis.

Janssen plans a separate study to bolster the hypothesis that guselkumab improves spinal symptoms associated with psoriatic arthritis.

Tremfya (guselkumab) won FDA approval for adult patients with act…

Tremfya shows promise in reducing fatigue in PsA patients

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 in fatigue through one year.

The results offer hope for PsA patients with disease-mediated fatigue — a symptom that doctors have traditionally underappreciated.

To arrive at their conclusion about guselkumab, the investigators used a mediation analysis, a statistical method that attempts to identify the relationship between variables. In this case, the analysis investigated the relationship between fatigue and a variety of PsA symptoms. Such measures included American College of Rheumatology criteria (ACR20) to measure joint improvement, the presence of C-reactive protein to study in…

Why Janssen believes next-gen drug Tremfya can meet unmet needs in psoriasis and beyond

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 us that psoriasis was an immunologic disease,” said Dr. Lloyd Miller, vice president, immunodermatology at Janssen Research & Development (NYSE:JNJ).

After researchers determined that psoriasis, which affects some 125 million patients worldwide, results from excess inflammatory cytokines, drug developers began to test the potential of inhibitors of tumor necrosis factor (TNF) and interleukin 17 (IL-17) in treating the disease.

FDA approved TNF blockers such as Janssen’s Remicade (infliximab) for psoriasis and psoriatic arthritis in the mid-2000s. IL-17A antagonists …

J&J’s Tremfya shows promise in psoriatic arthritis patients who are TNFi non-responders

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 20% improvement in joint symptoms using the American College of Rheumatology’s ACR20 scale, which requires at least a 20% improvement in several arthritis measures. Some 19.9% of placebo recipients had the same degree of improvement.

At one year, 57.7% achieved more than 20% improvement in joint symptoms using the American College of Rheumatology’s ACR20 scale, which requires at least a 20% improvement in several arthritis measures. Some 53.4% of the psoriatic arthritis patients had complete skin clearance.

“We’re basically continuing to develop the body of evidence to help physicians make d…

Phase 3 Tremfya results are promising for plaque psoriasis and psoriatic arthritis

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 year.

A total of 55% of patients receiving Tremfya had complete skin clearance, while 85% had an Investigator’s Global Assessment (IGA) score of either 0 or 1 at week 252 in the Phase 3 trial. IGA is a five-point system for characterizing psoriasis severity. A score of zero indicates complete clearing, while a score of one is for “almost clear” skin.

With 2020 sales hitting $1.35 billion, Tremfya is the only interleukin (IL)-23 inhibitor that is FDA approved for both moderate-to-severe plaque psoriasis and psoriatic arthritis.

Janssen had concluded earlier that sev…