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16-Mar-2021

Data From Phase 3 Extension Study Show TREMFYA®▼ (guselkumab) Maintains Joint Efficacy and Complete Skin Clearance in Adult Patients with Active Psoriatic Arthritis (PsA) Through Two Years

Data From Phase 3 Extension Study Show TREMFYA®▼ (guselkumab) Maintains Joint Efficacy and Complete Skin Clearance in Adult Patients with Active Psoriatic Arthritis (PsA) Through Two Years

 

 

High Wycombe, UK, March 16, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced long-term data from the Phase 3 DISCOVER-2a study showing that the skin clearance, joint symptom relief, and safety of TREMFYA®▼ (guselkumab) previously demonstrated through 24 weeks (primary endpoint) and one year (week 52) in adults with active psoriatic arthritis (PsA) continued through two years (week 112).1,2 These findings show maintenance through two years of the benefits on improvement of joint symptoms and physical function. These data will be presented virtually in abstract, poster, and video form during the Innovations in Dermatology: Virtual Spring Conference 2021, March 16-20.[1],[2]

 

“PsA can be a chronically painful and debilitating disease and many PsA patients are still searching for enduring relief of their symptoms,” said Philip J. Mease,* M.D., of the Swedish Medical Center/Providence St. Joseph Health and University of Washington in Seattle, Washington and presenting author. “These data, which show that the observed benefits of guselkumab in PsA continue through two years, represent positive news for physicians and patients alike.”     

 

It is estimated that up to 123,000 people in the UK are living with PsA and up to 30% of those living with psoriasis may go on to develop PsA.[3][4]

 

“PsA is a chronic inflammatory disease of the skin, joints, and soft tissue and is a chronic condition; therefore, sustained control of this inflammation is important to physicians and patients,” said Alyssa Johnsen, M.D., Ph.D., Vice President, Rheumatology Disease Area Leader, Janssen Research & Development, LLC. “These long-term study results further bolster our confidence in the ability of guselkumab to significantly improve the diverse manifestations of PsA over time.”

 

 

 

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Footnotes:

  1. In DISCOVER-2, patients were randomised to guselkumab 100 mg at week 0 and 4, thereafter q4w or q8w for two years, or to placebo with crossover to guselkumab q4w at week 24 through two years.[5],[6]

 

About DISCOVER-1 (NCT03162796; EudraCT 2016-001163-37) and DISCOVER-2 (NCT03158285; EudraCT 2016-001224-63) 5,6,[7],[8]

DISCOVER-1 is a randomised, double-blind, multicentre Phase 3 study evaluating the efficacy and safety of guselkumab administered by subcutaneous (SC) injection in participants with active PsA, including those previously treated with one or two biologic tumour necrosis factor inhibitors. DISCOVER-1 evaluated 381 participants and continued through approximately one year.

 

The study consisted of a screening phase of up to six weeks, a blinded active treatment phase of 52 weeks that included a placebo-controlled period from week 0 to week 24 and an active treatment period from week 24 to week 52. It also included a safety follow-up phase of eight weeks after week 52 (week 52 to week 60; 12 weeks from the last administration of study agent at week 48 through to the final visit in the safety follow-up phase). Efficacy, safety, pharmacokinetic, immunogenicity and biomarker evaluations were performed in the study on a defined schedule.

 

DISCOVER-2 is a randomised, double-blind, multi-centre Phase 3 study evaluating the efficacy and safety of guselkumab administered by SC injection in patients with active PsA. DISCOVER-2 evaluated 739 participants and continued through approximately two years.

 

The study consisted of a screening phase of up to six weeks, a blinded active treatment phase (approximately 100 weeks) that included a placebo-controlled period from week 0 to week 24 and an active treatment period from week 24 to week 100. It also included a safety follow-up phase of 12 weeks after the last administration of study agent. Clinical efficacy, radiographic efficacy, health economics, safety, pharmacokinetics, immunogenicity, biomarker, and pharmacogenomics evaluations were performed in the study on a defined schedule.

 

Previously announced DISCOVER-1 and DISCOVER-2 data showed guselkumab demonstrated improvements in multiple clinical outcomes of PsA including joint symptoms, skin symptoms, soft tissue inflammation, physical function, axial-related disease, fatigue as measured by Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F) Scale, and low rates of radiographic progression compared to placebo at week 24; these improvements were maintained in the active treatment phase through week 52.[9],[10],[11],[12],[13],[14],[15]  

 

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 (severe inflammation of the finger and toe joints), axial disease, and the skin lesions associated with PsO.[16], [17],[18] In addition, in patients with PsA, comorbidities such as obesity, cardiovascular diseases, anxiety and depression are often present.[19] Studies show up to 30 percent of people with PsO also develop PsA.[20],[21]  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 time.[22] 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.[23] 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 a fully human monoclonal antibody that selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor.[24]

 

Guselkumab is approved as a prescription medicine in the EU for the treatment of adult patients with moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy, and also has approved indications in PsO in the US, Canada, Japan and a number of other countries worldwide for the treatment of adult patients with moderate to severe plaque PsO who may benefit from injections or pills (systemic therapy), or phototherapy (treatment using ultraviolet [UV] light).25

 

In November 2020, guselkumab was approved by the European Commission for adults with active PsA who have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy.25 The PsA approval was based on results from DISCOVER-1 and DISCOVER-2, which showed guselkumab reached each study’s primary endpoint of ACR 20 response at 24 weeks.5,6,7,8 Complete study results were previously published in The Lancet.9,10

 

IL-23 is an important driver of the pathogenesis of inflammatory immune-mediated diseases such as PsO and PsA.[25] In the EU, guselkumab is administered as a 100 mg SC injection once every 8 weeks, after starter doses at weeks 0 and 4 for both plaque PsO and PsA, with 100 mg SC doses every 4 weeks considered in patients with PsA who are at high risk for joint damage according to clinical judgement.25

 

The Janssen Pharmaceutical Companies of Johnson & Johnson maintain exclusive worldwide marketing rights to TREMFYA®.

 

 

Important Safety Information25

Very common (≥10 percent) and common AEs (≥1 percent) in controlled periods of clinical studies with guselkumab were respiratory tract infections, increased transaminases, headache, diarrhoea, arthralgia and injection site reactions. Uncommon AEs (≥0.1 percent) observed were herpes simplex infections, tinea infections, gastroenteritis, decreased neutrophil count, hypersensitivity, anaphylaxis, urticaria and rash. Most were considered to be mild and did not necessitate discontinuation of study treatment.

 

When prescribing guselkumab q4w in psoriatic arthritis, it is recommended to evaluate liver enzymes at baseline and thereafter according to routine patient management. If increases in ALT or AST are observed and drug-induced liver injury is suspected, guselkumab should be temporarily interrupted until this diagnosis is excluded.

Please refer to the Summary of Product Characteristics for full prescribing information for guselkumab: https://www.ema.europa.eu/en/medicines/human/EPAR/tremfya#product-information-section.

▼ AEs should be reported. This medicinal product is subject to additional monitoring and it is therefore important to report any suspected AEs related to this medicinal product. 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. AEs should also be reported to Janssen-Cilag Ltd on 01494 567447.

 

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 Janssen 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, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.

 

Learn more at www.janssen.com/uk/.

Follow us at www.twitter.com/JanssenUK.

 

Janssen-Cilag International NV, the marketing authorisation holder for TREMFYA® in the EU, and Janssen Research & Development, LLC, are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

 

Cautions Concerning Forward-Looking Statements

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding ongoing and planned development efforts involving TREMFYA® (guselkumab) as a treatment for adult patients with active psoriatic arthritis. 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 Research & Development, LLC, any of the other Janssen Pharmaceutical Companies 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 3, 2021, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s most recently filed Quarterly Report on Form 10-Q, and the company’s subsequent 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 the Janssen Pharmaceutical Companies 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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*Dr Mease is a paid consultant for Janssen. He has not been compensated for any media work.

 

References

 

  • McInnes I, et al. Efficacy and Safety of Guselkumab, a Monoclonal Antibody Specific to the p19-Subunit of Interleukin-23, Through 2 Years: Results from a Phase 3, Randomized, Double-blind, Placebo-controlled Study Conducted in Biologic-naïve Patients with Active Psoriatic Arthritis. Presented at the 2021 Innovations in Dermatology: Virtual Spring Conference; March 16–20 (ABSTRACT)

 

March 2021

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Last Updated: 16-Mar-2021