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…

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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…
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FDA approves second indication of AbbVie’s Skyrizi for adults with active psoriatic arthritis

FDA first approved AbbVie’s (NYSE:ABBV) interleukin-23 inhibitor Skyrizi (risankizumab-rzaa) for moderate to severe plaque psoriasis in 2019. Now, the agency has extended the approval to include adults with active psoriatic arthritis (PsA), which affects almost one out of three people with psoriasis.

To win the new indication, AbbVie provided data from the KEEPsAKE-1 and KEEPsAKE-2 pivotal studies. Those studies tested Skyrizi in adults with active PsA, including refractory patients.

In the placebo-controlled KEEPsAKE trials, Skyrizi met the primary endpoint of ACR20 at week 24. ACR20 is a composite measure from the American College of Rheumatology that refers to 20% improvement across several variables, including swollen, tender and painful joints.

“In the pivotal KEEPsAKE trials, Skyrizi demonstrated improvements across a number of psoriatic arthritis symptoms, including joint pain, enthesitis and dactylitis,” said Dr. Alan J. Kivitz, KEEPsAKE clinical…

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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…

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AbbVie shares new Rinvoq data involving patients with psoriatic arthritis 

Abbvie’s JAK inhibitor Rinvoq (upadacitinib) beat out placebo at week 24 in posthoc analyses of two Phase 3 studies focused on people with active psoriatic arthritis. In particular, the drug led to a superior clinical response related to axial involvement, which occurs in a substantial portion of people with psoriatic arthritis.

Sharing the data at the American College of Rheumatology (ACR) Convergence 2021 conference, AbbVie says the data underscore the drug’s potential for many people with psoriatic arthritis. “These data further add to the body of evidence that support the potential of upadacitinib to be an important treatment option that helps reduce the impact of the many disease manifestations of psoriatic arthritis,” said Dr. Thomas Hudson, senior vice president, research and development, chief scientific officer of AbbVie, in a press release.

Last year, Rinvoq generated $731 million in net revenues globally.

FDA approved Rinvoq in 2019 to treat m…

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AbbVie wins CHMP positive opinion to use Skyrizi as an active psoriatic arthritis treatment 

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 or more disease-modifying antirheumatic drugs.

CHMP recommended an initial 150-mg of subcutaneous injection of Skyrizi followed by subsequent doses at four weeks and then every 12 weeks after that.

In the U.S., the drug is indicated for certain adults with moderate-to-severe plaque psoriasis. FDA approved the drug in 2019.

In April, North Chicago–based AbbVie announced that it had submitted paperwork to the FDA for the indication of psoriatic arthritis.

Approval for psoriatic arthritis in Europe and the U.S. would elevate AbbVie’s stature in tha…

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Janssen presents new safety data for Stelara in older patients

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 13 clinical trials across approved indications, including Crohn’s disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis. The analysis included data for up to five years.

“This particular analysis builds on the complete data we have on the safety of Stelara over thousands of patients and literally dozens of clinical trials over 20 years now,” said Dr. Andrew Greenspan, vice president of medical affairs at Janssen Immunology.

The analysis is also noteworthy in its focus on patients 60 and older, Greenspan said.

“Often, we limit patients who are older from the clinical trials, and that’s not …

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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…

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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…

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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…

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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…

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