guselkumab Archives - Medical Design Sourcing

Guselkumab shows durable benefits in Crohn’s disease in LTE of phase 2 study

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 the three-year mark, compared to 46.0% for those treated with Stelara (ustekinumab), the company’s interleukin-12 and -23 antagonist that won FDA approval for CD in 2016. Patient-reported outcomes were also promising in the GALAXI trial, with 51.4% of guselkumab-treated patients achieving PRO-2 remission, a patient-reported outcome measurement used in inflammatory bowel disease (IBD) studies, compared to 39.7% for ustekinumab. From an endoscopic perspective, 34.7% of patients on guselkumab showcased a positive response, compared with 19.4% on ustekinumab.

An overview of GALAXI LTE …

Guselkumab could offer hope for psoriatic arthritis patients resistant to TNF inhibitors

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 minimal disease activity (MDA) over 48 weeks of treatment. TNF inhibitors are a class of medications that target and suppress the overproduction of the inflammatory protein TNF, making them a common treatment option for autoimmune diseases such as PsA.

The IL-23 inhibitor guselkumab provides a treatment alternative, recording sustained improvements in measures of minimal disease activity (MDA) over 48 weeks of treatment. In particular, 60 to 80% of patients achieved MDA across various measures.

Beyond guselkumab, another approved IL-23 inhibitor for the treatment of psori…

Guselkumab offers sustained improvements for psoriatic arthritis patients in phase 3b trial

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 (TNFi-IR).

The drug also had an acceptable safety profile in the study. These results are among 41 Janssen-backed abstracts being presented at the 2023 Annual European Congress of Rheumatology (EULAR) meeting scheduled for May 31 to June 3, 2023 in Milan.

In a separate post-hoc analysis of the phase 3 DISCOVER-1 and DISCOVER-2 studies, guselkumab demonstrated swift and long-lasting durability in all evaluated criteria, including dimensions related to patient-reported pain, physical components of health-related quality of life and fatigue.

Efficacy of guselkumab: A post-hoc anal…

Guselkumab analysis shows psoriatic arthritis patients with early efficacy had sustained benefit

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 guselkumab had meaningful improvements in health-related quality of life at week 100 compared to patients without such an early response.

“We’re now getting increasingly solid evidence that IL-23s are effective and have sustained effectiveness in psoriatic arthritis,” said Dr. Philip J. Mease, M.D. of the Swedish Medical Center/Providence St. Joseph Health and the University of Washington in Seattle, Washington.

The DISCOVER-2 trial was a randomized, double-blind, placebo-controlled study focused on biologic-naive patients with active psoriatic arthritis. In…

Guselkumab plus golimumab shows promise in Phase 2a ulcerative colitis trial

Janssen’s (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 golimumab were in clinical remission. By comparison, 31% of patients who received guselkumab alone had reached that state, while 21% of those on golimumab alone did.

Dr. Jan Wehkamp, vice president of Janssen R&D’s gastroenterology disease area, said the company received significant positive feedback on the study at the United European Gastroenterology (UEG) Week conference held earlier this month in Vienna.

The VEGA study provided the first positive data on a combination therapy in immunology, Wehkamp said. Combination therapy is established…

Janssen’s guselkumab and golimumab combination fares well in Phase 2a ulcerative colitis study

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 guselkumab and the TNFα inhibitor golimumab. After that period, the participants received guselkumab alone for maintenance.

At week 38, recipients of the guselkumab and golimumab combination therapy had a clinical remission rate of 47.9%. For the sake of comparison, the remission rate for guselkumab alone was 31.0%, while the rate for golimumab alone was 20.8%.

The study defined clinical response using the Mayo score, which is the sum of four subscores related to stool frequency, rectal bleeding, physician’s global assessment and endoscopy findings.

Groups in all three arms had s…

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…