ViewPoints Interview: Janssen’s Andrew Greenspan Shares Insights on the Data Presented at ACR2020

In a recent interview with PharmaShots, Andrew Greenspan, MD, VP Medical Affairs of Janssen Immunology shared his views on Janssen’s commitment to advance research in rheumatic disease.

Shots:

  • Janssen presented clinical trial results in 35 abstracts featuring findings across PsA, RA, and SLE at ACR Convergence 2020 Virtual Scientific Program
  • Sixteen abstracts focus on Tremfya in adults with active PsA, including 52-week safety and efficacy data, axial disease-related endpoints, and more.
  • Other presentations feature new research across Janssen’s portfolio of medications including Simponi Aria (golimumab), Stelara (ustekinumab), and Remicade (infliximab)

Tuba: How was your virtual experience at ACR2020? Can we have an insight on data presented at ACR 2020?

Andrew: Speaking on behalf of those who represented Janssen at the conference – we are so proud of the breadth of data presented at ACR this year. Even though the conference looked a little different than it has in years past, we were still thrilled to share our findings – including 35 abstracts highlighting our research across psoriatic arthritis, rheumatoid arthritis and system lupus erythematosus. Specifically, we presented 16 abstracts focused on TREMFYA in adults with active psoriatic arthritis, including 52-week safety and efficacy data, spinal disease-related endpoints, as well as analyses that highlight patient-reported outcome measures including fatigue. Other presentations featured new research across our portfolio of medications.

Tuba: As the focus of the presentation is Tremfya, give a quick review about the clinical data supporting the therapy?

Janssen’s Tremfya (guselkumab) Receives the US FDA's Approval as the First Selective IL-23 Inhibitor for Active Psoriatic Arthritis
Source: MPR

Andrew: As a company, we’re constantly striving to keep our foot on the gas to create new clinical evidence and innovation. As a testament to this, we were proud to expand our rheumatology portfolio this year with the U.S. FDA approval of TREMFYA for adult patients with active psoriatic arthritis, which was first approved to treat adults with plaque psoriasis in 2017. Let me share some additional information on the compelling data we shared at ACR:

  • Data from two Phase 3 clinical trials, DISCOVER-1 and DISCOVER-2, showed that TREMFYA improved fatigue in adult patients with active psoriatic arthritis and maintained response through 52 weeks of active treatment, as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale. TREMFYA is the first and only treatment approved for active psoriatic arthritis to have an improvement in fatigue as measured by FACIT-F in the product label.
  • The positive outcomes in fatigue assessment add to the body of data for TREMFYA, which has shown improvements in multiple clinical outcomes including joint symptoms, skin symptoms, soft tissue inflammation, and physical function.
  • Fatigue is considered one of the three most important symptoms by patients with active psoriatic arthritis, and moderate to severe fatigue occurs in up to 50 percent of these patients.

Tuba: Can we have a glance at Janssen’s immunology portfolio as it is working in immunology over the past two decades?

Source: Janssen

Andrew: At Janssen, we have an unmatched track record of translating science into effective therapeutics. In the past two decades, my colleagues at Janssen have developed five advanced treatments for 31 indications resulting in the treatment of more than 5 million patients living with autoimmune disease. Treatments in our immunology portfolio treat a variety of conditions for various patient populations, such as plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, polyarticular juvenile idiopathic arthritis, rheumatoid arthritis, ulcerative colitis and Crohn’s disease. These treatments include TREMFYA (guselkumab), SIMPONIARIA (golimumab), STELARA (ustekinumab), SIMPONI (guselkumab) and REMICADE (infliximab). Looking ahead to potential future treatments, we have a robust pipeline, with 21 first-in-class Phase 2 or 3 trials underway. We’re eager to explore treatment options for less common diseases like hidradenitis suppurativa and Sjogren’s syndrome, where there are fewer or no advanced treatment options currently available.

Tuba: What are Janssens’s efforts in developing biomarkers and co-diagnostics to personalize medicine in the field of rheumatic diseases?

Andrew: We are exploring the development of tools that will better allow us to measure disease activity in patients, including sensors (digital health, actigraphy), novel biomarkers, new endpoints and new patient-reported outcomes to better identify patients appropriate for our medicines and to evaluate the efficacy and safety of them.

 Tuba:  Apart from Tremfya, Simponi, Simponi Aria, and Stelara, what next can we expect from Janssen to transform the lives of patients with autoimmune diseases? What will be your next move (in terms of the combination of internal research and development, external collaborations, and industry consortia) to complement Janssen’s existing portfolio of immunology? Who are Janssen’s potential competitors in the field of autoimmune diseases?

Andrew: I’m very proud of where our research in immunology stands and where it is leading us. While treatments today have made a big difference in the lives of many patients, there certainly remains a significant need for medicines that work better, faster, and longer. Instead of focusing on the competition, we prefer to focus on unmet needs. By unlocking new pathways, mechanisms, and regimens in our treatment options, we strive to provide innovative treatment options to patients. Looking further ahead at our mid-to-late stage pipeline, we have 21 first-in-class Phase 2 or 3 trials underway and we’re eager to explore treatment options for less common diseases like hidradenitis suppurativa and Sjogren’s syndrome, where there are fewer or no advanced treatment options currently available.

Tuba: Can we have a glimpse of Janssen’s work in other therapeutics areas? Can you list out some key advancements for our readers?

Andrew: In addition to immunology, we focus on areas of medicine where we can make the most impact, including Cardiovascular & Metabolism, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension, where we have delivered 18 new medicines in less than nine years. For more information about these specific therapeutic areas, I would be happy to put you in touch with a specialist on our team to learn more about the innovative work being done in these fields.

Tuba: Does the global pandemic affect Janssen’s ongoing as well as future clinical trials?

Andrew: As the world continues to navigate the new normal brought on by COVID-19, there has been an undeniable effort to ensure continuity of care and advance research by a wide range of experts, from healthcare professionals and clinical trial site teams to research partners and regulatory bodies. We at Janssen recognize and remain committed to supporting everyone involved in clinical research. To learn more about Janssen’s commitment to clinical trial research, visit: https://www.janssen.com/clinical-trials/janssen-global-development-leadership-commitment-clinical-research.

Image Source: MIMS Malaysia

About Author:

Andrew Greenspan, MD is a vice president of Immunology Medical Affairs at Janssen and has joined J&J in 2003.

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Janssen’s Tremfya (guselkumab) Receives EC’s Approval as a First in Class Treatment for Active Psoriatic Arthritis

Shots:

  • The approval is based on P-lll DISCOVER-1 & -2 study assessing Tremfya (100mg q4w and q8w) vs PBO in 381 & 739 patients with active PsA who had an inadequate response to SOC &
  • Who were biologic-naïve only and had an inadequate response to SOC respectively
  • Combined results: achieved 1EPs of ACR20 @24wks.; improvements in quality of life scores; improvement in PASI 75, PASI 90, and PASI 100 rates. In DISCOVER-2 study, @24wks. less radiographic progression in both groups Tremfya is the first selective IL-23 p19 subunit inhibitor licensed for both the treatment of PsA and PsO

Click here ­to­ read full press release/ article | Ref: Janssen | Image: The Pharma Letter

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Janssen’s Tremfya (guselkumab) Receives CHMP’s Positive Opinion for Approval to Treat Active Psoriatic Arthritis (PsA)

Shots:

  • The CHMP’s positive opinion is based on P-III DISCOVER-1 & -2 studies assessing guselkumab (100 mg, q4w/q8w) vs PBO in 381 & 739 patients with active PsA & patients who were biologic-naïve only & who had an inadequate response to standard therapies respectively
  • Combined results: @24wks. improvement in ACR (20%); improvements in quality of life scores SF36; higher PASI 75, PASI 90, and PASI 100 response rate were observed. In both studies, Tremfya was generally well tolerated through study completion
  • Guselkumab is the first approved mAb that selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor. If approved, guselkumab will be the first selective (IL)-23 p19 subunit inhibitor licensed for both PsA and moderate to severe PsO

Click here ­to­ read full press release/ article | Ref: Janssen | Image: PMLive

The post Janssen’s Tremfya (guselkumab) Receives CHMP’s Positive Opinion for Approval to Treat Active Psoriatic Arthritis (PsA) first appeared on PharmaShots.