People living with treatment-resistant active psoriatic arthritis reported meaningful improvements in pain, physical function and fatigue on guselkumab through six months. Additional pooled data from three clinical trials support the established efficacy of guselkumab in key psoriatic domains across those who were bio-naïve or TNFi-experienced
Beerse, Belgium , Nov. 08, 2023 (GLOBE NEWSWIRE) — FOR EUROPEAN AND UK MEDICAL AND TRADE MEDIA ONLY
BEERSE, BELGIUM, 8 November 2023 – Janssen Pharmaceuticals, Inc., a Johnson & Johnson company, today announced new data from the CorEvitas Psoriatic Arthritis (PsA) and Spondyloarthritis Registry that showed a substantial proportion of people living with treatment-resistant active PsA and using TREMFYA® (guselkumab) in real-world settings reported meaningful improvements in pain, physical function and fatigue through six months.1 Additionally, across the DISCOVER-1, DISCOVER-2 and COSMOS clinical trials, treatment with guselkumab was associated with higher rates of clinically meaningful improvements in a composite assessment of patient-reported pain, fatigue, physical function, skin problems and PsA-related depression than placebo in the first assessment of the PsA 5-Thermometer Scale Domains (PsA-5T-Ds).2
Guselkumab is the only fully human selective interleukin (IL)-23p19-subunit inhibitor therapy approved for the treatment of adults living with active PsA.3,4 These study results are among 24 company-sponsored abstracts being presented by Janssen at the American College of Rheumatology (ACR) Convergence 2023 meeting taking place in San Diego, CA, 10-15 November 2023.
“People living with active psoriatic arthritis who are treatment-resistant need options that improve debilitating symptoms of their disease, like pain, physical function and fatigue,” said Philip Mease, M.D., Swedish Medical Center/Providence St. Joseph Health and University of Washington in Seattle, Washington.a “It is important that we assess patient-reported outcomes in a real-world setting, ensuring that we address unmet needs for people living with this challenging disease.”
CorEvitas data showed patients characterised by longstanding, treatment-resistant, active disease reported meaningful improvements in pain, physical function and fatigue.1
In this analysis of the CorEvitas registry data,b substantial proportions of on-label guselkumab persistersc (n=90) reported clinically meaningful improvements from baseline (unadjusted nominal p values):1
Analysis of DISCOVER-1, DISCOVER-2 and COSMOS clinical trials supports established guselkumab efficacy across key PsA patient-reported outcomes.2
In the first assessment of the PsA-5T-Dse longitudinal construct validity, in people living with PsA who were bio-naïve or who had an inadequate response to one or two tumour necrosis factor inhibitors (TNFis),f this composite score of five patient-reported outcomes showed a strong correlation with the Psoriatic Arthritis Disease Activity Score (PASDAS), a validated instrument that encompasses most core PsA domains, and a good ability to discriminate between those with and without clinically meaningful improvements in disease activity and health-related quality of life.2
“These new guselkumab results demonstrate our commitment to addressing symptoms that impact people living with active psoriatic arthritis, including depression, pain, fatigue, physical function and skin problems,” said Terence Rooney, M.D., Vice President, Rheumatology, Immunology Disease Area Leader, Janssen Research & Development, LLC. “It is critical that we evaluate patient-reported outcomes to truly understand the lived experiences of patients and better develop and provide treatments in psoriatic disease.”
Editor’s Notes:
About CorEvitas
The CorEvitas PsA/Spondyloarthritis (SpA) Registry is a prospective, observational registry for patients living with PsA or SpA in the United States under the care of a rheumatologist.1,6 Response rates at six months were determined for established outcomes related to improvements or achievement of low levels of disease activity in patient-reported pain (0-100 mm visual analogue scale [VAS]), patient global assessment of arthritis and psoriasis (patient global assessment [PtGA]; 0-100 mm VAS), and HAQ-DI (0-3).1 On average, patients had longstanding, treatment-resistant, active PsA.1
About DISCOVER-1 (NCT03162796)
DISCOVER-1 was a Phase 3, multicentre, randomised, double-blind study evaluating the efficacy and safety of guselkumab administered by subcutaneous injection in participants with active PsA, including those previously treated with one to two TNFis.7 DISCOVER-1 evaluated 381 participants who were randomised and treated.8 The study consisted of a screening phase of up to six weeks, a blinded treatment of 52 weeks that included a placebo-controlled period from week 0 to week 24, and a blinded active treatment period from week 24 to week 52.7 It also included a safety follow-up phase through week 60 (i.e., approximately 12 weeks from the last administration of the study agent at week 48).7 Efficacy, safety, pharmacokinetic, immunogenicity and biomarker evaluations were performed in the study on a defined schedule.7 The primary endpoint was response of ACR20 at week 24.7
About DISCOVER-2 (NCT03158285)
DISCOVER-2 was a Phase 3, multicentre, randomised, double-blind study evaluating the efficacy and safety of guselkumab administered by subcutaneous injection in biologic-naïve patients with active PsA.9 DISCOVER-2 evaluated 739 participants who were randomised and treated.10 The study consisted of a screening phase of up to six weeks, a blinded treatment phase of approximately 100 weeks that included a placebo-controlled period from week 0 to week 24 and a blinded active treatment period from week 24 to week 100.9 It also included a safety follow-up phase through week 112 (i.e., approximately 12 weeks after the last administration of study agent at week 100).9 Clinical efficacy, radiographic efficacy, health economics, safety, pharmacokinetics, immunogenicity, biomarker and pharmacogenomics evaluations were performed in the study on a defined schedule.9 The primary endpoint was response of ACR20 at week 24.9
About COSMOS (NCT03796858)
COSMOS was a Phase 3b, multicentre, randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of guselkumab, administered by subcutaneous injection, in 285 adult patients with active PsA and inadequate response to TNFi therapy.11 The primary endpoint was response of ACR20 at week 24.11 The primary endpoint results were announced in June 2021.12 Participants were randomised (2:1) to receive guselkumab 100 mg at weeks 0, 4 and every eight weeks thereafter, or placebo.11 The study included two periods: a 24-week double-blind, placebo-controlled period for the primary analysis of the efficacy and safety of guselkumab compared with placebo and a 32-week active-treatment and safety follow-up period for additional analysis of the efficacy and safety of guselkumab.11 Safety was monitored throughout the study to week 56.11,13 As such, the COSMOS safety results were consistent with the known safety profile of guselkumab in bio-naïve patients with PsA.8,10,14,15,16
About Psoriatic Arthritis
PsA is a chronic, immune-mediated, inflammatory disease characterised by peripheral joint inflammation, enthesitis (pain where the bone, tendon and ligament meet), dactylitis (a type of inflammation in the fingers and toes that can result in a swollen, sausage-like appearance), axial disease and the skin lesions associated with plaque psoriasis (Pso).17,18,19 The disease causes pain, stiffness and swelling in and around the joints; it commonly appears between the ages of 30 and 50, but can develop at any age.20 Nearly half of patients with PsA experience moderate fatigue and about 30 percent suffer from severe fatigue as measured by the modified fatigue severity scale.21 In patients with PsA, comorbidities such as obesity, cardiovascular disease, anxiety and depression are often present.22 Studies show up to 30 percent of people with plaque Pso also develop PsA.20 Although the exact cause of PsA is unknown, genes, the immune system and environmental factors are all believed to play a role in disease onset.23
About TREMFYA® (guselkumab)
Developed by Janssen, guselkumab is the first approved fully human monoclonal antibody that selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor.4,24 IL-23 is an important driver of the pathogenesis of inflammatory diseases such as moderate to severe plaque Pso and active PsA.24 Guselkumab is approved in the EU for the treatment of moderate to severe plaque Pso in adults who are candidates for systemic therapy, and alone or in combination with methotrexate for the treatment of active PsA in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug therapy.4 It is also approved in the U.S., Canada, Japan, and a number of other countries worldwide for the treatment of adults with moderate to severe plaque Pso who are candidates for injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light), and for the treatment of adult patients with active PsA.4,25,26
In vitro studies have demonstrated that guselkumab binds to CD64 expressed on the surface of IL-23 producing cells, and captures IL-23 produced from these same cells when bound to CD64 in an inflammatory monocyte model.27 The clinical significance of this finding is not known.28
The Janssen Pharmaceutical Companies of Johnson & Johnson maintain exclusive worldwide marketing rights to TREMFYA®.
GUSELKUMAB IMPORTANT SAFETY INFORMATION
In controlled periods of clinical studies with guselkumab, adverse drug reactions (ADRs) that consisted of respiratory tract infections were very common (≥10 percent); increased transaminases, headache, diarrhoea, arthralgia, and injection site reactions were common (≥1 to <10 percent); and herpes simplex infections, tinea infections, gastroenteritis, decreased neutrophil count, hypersensitivity, anaphylaxis, urticaria and rash were uncommon ADRs (≥0.1 percent to <1 percent).4
Please refer to the Summary of Product Characteristics for full prescribing information for guselkumab in Pso and PsA: https://www.ema.europa.eu/en/documents/product-information/tremfya-epar-product-information_en.pdf
ADRs should be reported. Reporting forms and information can be found at
www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. ADRs should also be reported to Janssen-Cilag Ltd. on +44 (0) 1494567447.
About the Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular, Metabolism & Retina; Immunology; Infectious Diseases & Vaccines; Neuroscience; Oncology; and Pulmonary Hypertension.
Learn more at www.janssen.com/emea.
Follow us at www.twitter.com/JanssenEMEA.
Janssen-Cilag International NV, the marketing authorisation holder for TREMFYA® in the EU, and Janssen Research & Development, LLC are Johnson & Johnson companies.
Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding guselkumab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Pharmaceuticals, Inc., Janssen Research & Development, LLC, Janssen Biotech, Inc., Janssen Scientific Affairs, LLC and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behaviour and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 1, 2023, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of Janssen Pharmaceuticals, Inc., Janssen Research & Development, LLC, Janssen Biotech, Inc., Janssen Scientific Affairs, LLC nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
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References
1 Mease PJ, et al. Improvements in Patient-Reported Outcomes Through 6 Months of Guselkumab Treatment in Patients With Active Psoriatic Arthritis: Real-World Data From the CorEvitas Psoriatic Arthritis/Spondyloarthritis (PsA/SpA) Registry. Presented at ACR Convergence 2023, Nov. 10-15.
2 Selmi C, et al. Longitudinal Evaluation of the Novel Psoriatic Arthritis 5-Thermometer Scale (PsA-5Ts) Domains During Treatment with Guselkumab: Pooled Analysis of Three Phase 3, Randomized, Double-blind, Placebo-Controlled Studies. Presented at ACR Convergence 2023, Nov. 10-15.
3 Go-ahead for first anti-IL-23 mAb to treat psoriasis. Nature Biotechnology volume 35, page806 (2017). Available at: https://www.nature.com/articles/nbt0917-806. Accessed October 2023.
4 European Medicines Agency. TREMFYA Summary of Product Characteristics. Last Updated July 2022. Available at: https://www.ema.europa.eu/en/documents/product-information/tremfya-epar-product-information_en.pdf. Accessed October 2023.
5 Bruce, B., & Fries, J. F. (2003). The Stanford Health Assessment Questionnaire: Dimensions and Practical Applications. Health and Quality of Life Outcomes. 2003;1(1), 20.
6 CorEvitas Psoriatic Arthritis / Spondyloarthritis Registry. Available at: https://www.corevitas.com/registry/psa-spa/. Accessed October 2023.
7 ClinicalTrials.gov. A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis Including Those Previously Treated With Biologic Anti-Tumor Necrosis Factor (TNF) Alpha Agent(s) (DISCOVER 1). Identifier: NCT03162796. Available at: https://clinicaltrials.gov/ct2/show/NCT03162796. Accessed October 2023.
8 Ritchlin, C. T., et al. Guselkumab, an Inhibitor of the IL-23p19 Subunit, Provides Sustained Improvement in Signs and Symptoms of Active Psoriatic Arthritis: 1 Year Results of a Phase III Randomised Study of Patients Who Were Biologic-Naïve or TNFa Inhibitor-Experienced. RMD Open 2021;7:e0001457. Available at: https://pubmed.ncbi.nlm.nih.gov/33568556/. Accessed October 2023.
9 ClinicalTrials.gov. A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis. Identifier: NCT03158285. Available at: https://clinicaltrials.gov/ct2/show/NCT03158285. Accessed October 2023.
10 McInnes, I. B., et al. Long-Term Efficacy and Safety of Guselkumab, a Monoclonal Antibody Specific to the p19 Subunit of Interleukin-23, Through Two Years: Results From a Phase III, Randomized, Double-Blind, Placebo-Controlled Study Conducted in Biologic-Naive Patients With Active Psoriatic Arthritis. Arthritis Rheumatol 2022;74(3):275-485. Available at: https://pubmed.ncbi.nlm.nih.gov/34719872/. Accessed October 2023.
11 Clinicaltrials.gov. A Study of Guselkumab in Participants with Active Psoriatic Arthritis and an Inadequate Response to Anti-Tumor Necrosis Factor Alpha (Anti-TNF Alpha) Therapy (COSMOS). Identifier: NCT03796858. Available at: https://clinicaltrials.gov/ct2/show/NCT03796858. Accessed October 2023.
12 Johnson & Johnson. Press Release. New Phase 3b Psoriatic Arthritis (PsA) Data Show First-in-Class TREMFYA® (guselkumab) Achieved Robust Joint Symptom Improvement and Complete Skin Clearance in Patients with Inadequate Response to Tumor Necrosis Factor Inhibition (TNFi-IR). Available at: https://www.jnj.com/new-phase-3b-psoriatic-arthritis-psa-data-show-first-in-class-tremfya-guselkumab-achieved-robust-joint-symptom-improvement-and-complete-skin-clearance-in-patients-with-inadequate-response-to-tumor-necrosis-factor-inhibition-tnfi-ir. Accessed October 2023.
13 Coates, L., et al. Efficacy and safety of guselkumab in patients with active psoriatic arthritis who are inadequate responders to tumour necrosis factor inhibitors: results through one year of a phase IIIb, randomized, controlled study (COSMOS). Ann Rheum Dis 2021;0:1-11. Available at: https://pubmed.ncbi.nlm.nih.gov/34819273/. Accessed October 2023.
14 Ritchlin, C. T., et al. Multidomain Efficacy and Safety of Guselkumab Through 1 Year in Patients With Active Psoriatic Arthritis With and Without Prior Tumor Necrosis Factor Inhibitor Experience: Analysis of the Phase 3, Randomized, Placebo-Controlled DISCOVER-1 Study. ACR Open Rheumatology 2023;5(3):149-164. Available at: https://ncbi.nlm.nih.gov/pmc/articles/PMC10010489/. Accessed October 2023.
15 Deodhar, A., et al. Guselkumab in Patients with Active Psoriatic Arthritis who were Biologic-Naïve or had Previously Received TNFa Inhibitor Treatment (DISCOVER-1): A Double-Blind, Randomised, Placebo-Controlled Phase 3 Trial. Lancet 2020;4(395):1115-1125. Available at: https://pubmed.ncbi.nlm.nih.gov/32178765/. Accessed October 2023.
16 Mease, P., et al. Guselkumab in Biologic-Naïve Patients with Active Psoriatic Arthritis (DISCOVER-2): A Double-Blind, Randomised, Placebo-Controlled Phase 3 Trial. Lancet 2020;4(395):1126-1136. Available at: https://pubmed.ncbi.nlm.nih.gov/32178766/. Accessed October 2023.
17 Donvito T., CreakyJoints: What Is Dactylitis? The ‘Sausage Finger’ Swelling You Should Know About. Available at: https://creakyjoints.org/symptoms/what-is-dactylitis/. Accessed October 2023.
18 Belasco J., Wei N. Psoriatic Arthritis: What is Happening at the Joint? Rheumatol Ther. 2019 Sep;6(3):305-315. Available at: https://pubmed.ncbi.nlm.nih.gov/31102105/. Accessed October 2023.
19 Gower, T. Enthesitis and PsA. Arthritis Foundation. Available at: https://www.arthritis.org/health-wellness/about-arthritis/related-conditions/physical-effects/enthesitis-and-psa. Accessed October 2023.
20 National Psoriasis Foundation. About Psoriatic Arthritis. Available at: https://www.psoriasis.org/about-psoriatic-arthritis/. Accessed October 2023.
21 Husted J.A., et al. Occurrence and correlates of fatigue in psoriatic arthritis. Ann Rheum Dis, 2008:68(10), 1553–1558. Available at: https://doi.org/10.1136/ard.2008.098202. Accessed October 2023.
22 Haddad A., Zisman D. Comorbidities in Patients with Psoriatic Arthritis. Rambam Maimonides Med J 2017 Jan 30;8(1):e0004. Available at: https://doi.org/10.5041/RMMJ.10279. Accessed October 2023.
23 Cassell S., Kavanaugh A. Psoriatic arthritis: pathogenesis and novel immunomodulatory approaches to treatment. J Immune Based Ther Vaccines 2005 Sep 2;3:6. Available at: https://doi.org/10.1186/1476-8518-3-6. Accessed October 2023.
24 Food and Drug Administration. TREMFYA® Prescribing Information. Horsham, PA. 2017. Available at: https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/TREMFYA-pi.pdf. Accessed October 2023.
25 Japan Pharmaceuticals and Medical Devices Agency. Tremfya Report on the Deliberation Results. Available at: https://www.pmda.go.jp/files/000234741.pdf. Accessed October 2023.
26 The Canadian Agency for Drugs & Technologies in Health. TREMFYA Prescribing Information. Available at: https://pdf.hres.ca/dpd_pm/00042101.PDF. Accessed October 2023.
27 Atreya R, Abreu MT, Krueger JG, et al. P504 Guselkumab, an IL-23p19 subunit–specific monoclonal antibody, binds CD64+ myeloid cells and potently neutralises IL-23 produced from the same cells. Journal of Crohn’s and Colitis, Volume 17, Issue Supplement_1, February 2023, Pages i634–i635, https://doi.org/10.1093/ecco-jcc/jjac190.0634.
28 McGonagle D, et al. Guselkumab, an IL-23p19 Subunit–Specific Monoclonal Antibody, Binds CD64+ Myeloid Cells and Potently Neutralises IL-23 Produced From the Same Cells. Presented at EULAR 2023, May 31-June 3.
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November 2023
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