Janssen Welcomes Updated Recommendation From National Institute For Health And Care Excellence (NICE) Making Tremfya®▼(Guselkumab) Available For More People Living With Active Psoriatic Arthritis (PsA)

Janssen Welcomes Updated Recommendation From National Institute For Health And Care Excellence (NICE) Making Tremfya^®▼(Guselkumab) Available For More People Living With Active Psoriatic Arthritis (PsA)

 

TREMFYA^® (guselkumab) is the first fully human monoclonal IL-23 p19 subunit antibody inhibitor recommended in the UK for both the treatment of moderate to severe plaque psoriasis and eligible patients with active psoriatic arthritis^[i],ii

 

High Wycombe, UK, 08 July 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the National Institute for Health and Care Excellence (NICE) has updated its recommendation for TREMFYA^® (guselkumab), alone or with methotrexate, as an option for treating active psoriatic arthritis (PsA) in adults whose disease has not responded well enough to disease-modifying antirheumatic drugs (DMARDs) or who cannot tolerate them. It is recommended only if they have had 2 conventional DMARDs and:

• have had at least one biological DMARD, or
• tumour necrosis factor (TNF)-alpha inhibitors are contraindicated but would otherwise be considered.^[ii]

 

“Despite increasing numbers of therapies, there still exists a significant unmet need in psoriatic arthritis. Improving access to new therapies is crucial to enable clinicians to select the most appropriate therapy for each individual patient, so this is welcomed news for those living with PsA,” said Associate Professor Laura Coates*, NDORMS, University of Oxford, UK.

 

PsA is a progressive and multifaceted, chronic, immune-mediated inflammatory disease. It is characterised by debilitating joint damage and inflammation in addition to enthesitis, dactylitis, axial disease, and the skin lesions associated with psoriasis (PsO). The pain, stiffness and swelling of the joints and connective tissue can be severe and cause everyday tasks to become difficult.^[iii],[iv] According to estimates, up to 123,000 people in the UK live with PsA and up to 30 percent of those who live with PsO may go on to develop PsA but there is currently no known cure.^[v],[vi]

 

Patients living with PsA can manage symptoms through a mixture of lifestyle changes and medication, including conventional DMARDs.^{[vii],[viii],[ix]} If conventional DMARDs lose effectiveness, or are contraindicated, then other medications, such as guselkumab, may be offered.^ii,[x]

 

Guselkumab is already recommended by NICE as a clinical and cost-effective option for the treatment of eligible patients with moderate to severe plaque PsO, and in May 2021 was recommended for the treatment of a subgroup of eligible patients with moderate to severe PsA.^i,[xi]  With this latest recommendation, the NHS will now make guselkumab available in England and Wales within three months of the publication of the Technology Appraisal Guidance (TAG), to this wider population of patients with PsA, without restrictions based on PsO symptom severity.^[xii]

 

“We are pleased to welcome the latest recommendation from NICE which means guselkumab will be available for an expanded group of eligible PsA patients with fewer restrictions, in addition to those eligible patients with PsO. It is a vital step towards improving outcomes for people living with PsA, PsO, or both these debilitating conditions,” said Amanda Cunnington, Patient Access Director, Janssen-Cilag Limited. “We look forward to working with NICE and the NHS to ensure that treatments, like guselkumab, are available for use in clinical practice as quickly as possible as an alternative treatment for eligible patients.”

 

ENDS

 

*Dr Coates has received consultancy honoraria from Janssen. She has not been compensated for any media work.

 

 

About Psoriatic Arthritis

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 psoriasis (PsO).^{iv,[xiii],[xiv]} In addition, in patients with PsA, comorbidities such as obesity, cardiovascular diseases, anxiety and depression are often present.^[xv] Studies show up to 30% of people with PsO also develop PsA.^v,vi The disease causes pain, stiffness and swelling in and around the joints; it commonly appears between the ages of 25 and 50, but can develop at any time.^[xvi] Nearly half of patients with PsA experience moderate fatigue and about 30% suffer from severe fatigue as measured by the modified fatigue severity scale.^[xvii] Though the exact cause of PsA is unknown, genes, the immune system and environmental factors are all believed to play a role in the onset of the disease.^[xviii]

 

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.^x Guselkumab is approved as a prescription medicine in the UK for the treatment of adult patients with moderate to severe plaque PsO who are candidates for injections or pills (systemic therapy).^x It also has approved indications in PsO in the EU, 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 systemic therapy, or phototherapy (treatment using ultraviolet [UV] light).^{[xix],[xx],[xxi],[xxii]}   

 

Guselkumab was approved by the European Commission in November 2017 for adults with active PsA who have been intolerant to prior disease-modifying antirheumatic drug (DMARD) therapy.^xxi Guselkumab is also approved for PsA in the US, Canada, Japan and a number of other countries worldwide.^xix,xx,xxii 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. Complete study results were previously published in The Lancet.^[xxiii]

 

IL-23 is an important driver of the progression of inflammatory immune-mediated diseases such as PsO and PsA.^xxiii,[xxiv] IL-23 is one of a family of small proteins, called inflammatory cytokines, which are responsible for mediating inflammatory signals – signals that control when and where inflammation occurs – in the body.^[xxv] Many proteins are made up of subunits; IL-23 consists of two subunits, called “p19” and “p40”.^[xxvi] The “p19” subunit is unique to IL-23.^[xxvii] By targeting only IL-23, the underlying inflammation of PsA can be blocked without affecting other operations of the immune system, such as defence against infection and pathogens.

 

In the UK, guselkumab is administered as a 100 mg subcutaneous (SC) injection once every 8 weeks, after starter doses at weeks 0 and 4 for both 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.^x

 

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

 

Important safety information^x

Very common (≥10%) and common AEs (≥1%) 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%) 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.

 

In PsA clinical studies, an increased incidence of liver enzyme elevations was observed in patients treated with guselkumab q4w compared to patients treated with guselkumab q8w or placebo.

 

When prescribing guselkumab q4w in PsA, 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.

 

 

Assess the response to guselkumab from 16 weeks. Stop guselkumab at 24 weeks if the psoriatic arthritis has not responded adequately using the Psoriatic Arthritis Response Criteria (PsARC; an adequate response is an improvement in at least 2 of the 4 criteria, 1 of which must be joint tenderness or swelling score, with no worsening in any of the 4 criteria). If the PsARC response is not adequate but there is a Psoriasis Area and Severity Index (PASI) 75 response, a dermatologist should decide whether continuing treatment is appropriate based on skin response.ⁱⁱ

 

Please refer to the full Summary of Product Characteristics for full prescribing information for guselkumab: https://www.medicines.org.uk/emc/product/9587/smpc.

 

▼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 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/uk.

Follow us at www.twitter.com/JanssenUK.

 

Janssen-Cilag International NV, the marketing authorisation holder for TREMFYA^® in the EU, Janssen-Cilag Limited 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 TREMFYA^® (guselkumab) product development. 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 behavior 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 2, 2022, 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 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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July 2022

 

[i] National Institute for Health and Care Excellence. Guselkumab for treating moderate to severe plaque psoriasis [TA521]. Available at: https://www.nice.org.uk/guidance/ta521. Accessed July 2022.

[ii] National Institute for Health and Care Excellence. Guselkumab for treating active psoriatic arthritis after inadequate response to DMARDs [ID403]. Available at: https://www.nice.org.uk/guidance/indevelopment/gid-ta11078.  Accessed July 2022.

[iii] Busse K, Liao W. Which Psoriasis Patients Develop Psoriatic Arthritis? Psoriasis Forum 2010;16(4):17–25.

[iv] Belasco J, Wei N. Psoriatic Arthritis: What is Happening at the Joint? Rheumatol Ther 2019;6(3):305–315.

[v] Ogdie A, et al. Prevalence and treatment patterns of psoriatic arthritis in the UK. Rheumatology (Oxford). 2013;52(3):568-75.

[vi] Lenman, M. et al. Diagnosis and management of psoriatic arthropathy in primary care. British Journal of General Practice. 2014; 64 (625): 424-425.

[vii] NHS. Psoriatic Arthritis. Available at: Psoriatic arthritis - NHS (www.nhs.uk). Accessed July 2022

[viii] Pezzolo E and Naldi L. The relationship between smoking, psoriasis and psoriatic arthritis. Expert Rev Clin Immunol. 2019;15(1):41-48

[ix] Kumkethkar and Ogdie. Obesity and Psoriatic Arthritis: A Narrative Review. Rheumatol Ther. 2020;7:447–456

[x] EMC. Tremfya summary of product characteristics. Available at: https://www.medicines.org.uk/emc/product/9587/smpc Accessed July 2022.

[xi] National Institute for Health and Care Excellence. Guselkumab for treating active psoriatic arthritis after inadequate response to DMARDs [TA711]. Available at: https://www.nice.org.uk/guidance/ta711. Accessed: July 2022.

[xii] National institute for Health and Care Excellence (NICE). 2018. Guide to the processes of technology appraisal. Available at: https://www.nice.org.uk/process/pmg19/chapter/acknowledgements. Accessed June 2022.

[xiii] Creaky Joints. What is Enthesitis? Available at: https://creakyjoints.org/symptoms/what-is-enthesitis/. Accessed July 2022.

[xiv] Creaky Joints. What is Dactylitis? Available at: https://creakyjoints.org/symptoms/what-is-dactylitis/. Accessed July 2022.

[xv] Haddad A, Zisman D. Comorbidities in Patients with Psoriatic Arthritis. Rambam Maimonides Medical Journal. 2017;8(1):e0004

[xvi] Versus Arthritis. All About Psoriatic Arthritis. Available at: https://www.versusarthritis.org/news/2020/january/all-about-psoriatic-arthritis/ Accessed July 2022

[xvii] Husted JA, et al. Occurrence and correlates of fatigue in psoriatic arthritis. Annals of the Rheumatic Diseases 2008;68(10):1553–1558.

[xviii] Mayo Clinic. Psoriatic arthritis. Available at: https://www.mayoclinic.org/diseases-conditions/psoriatic-arthritis/symptoms-causes/syc-20354076. Accessed July 2022.

[xix] JnJ. Janssen announces U.S. FDA Approval of TREMFYA™ (guselkumab) for the Treatment of Moderate to Severe Plaque Psoriasis. Available at: https://www.jnj.com/media-center/press-releases/janssen-announces-us-fda-approval-of-tremfya-guselkumab-for-the-treatment-of-moderate-to-severe-plaque-psoriasis. Accessed July 2022.

[xx] MorphoSyS. MorphoSys Announces Approval of Tremfya(R) (Guselkumab) for the Treatment of Moderate to Severe Forms of Psoriasis and Psoriatic Arthritis in Japan. Available at: http://www.morphosys.com/media-investors/media-center/morphosys-announces-approval-of-tremfyar-guselkumab-for-the-treatment#:~:text=(Janssen)%20reported%20that%20Japan%27s%20Ministry,other%20existing%20treatments%20have%20failed. Accessed July 2022.

[xxi] EMA. Tremfya Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/tremfya-epar-product-information_en.pdf. Accessed July 2022.

[xxii] Janssen. Health Canada Approves TREMFYA®* (guselkumab injection), a First-In-Class
Selective Interleukin (IL)-23 Inhibitor for Active Psoriatic Arthritis. Available at: http://johnsonandjohnson.gcs-web.com/static-files/21d7d6d7-fdca-4b09-a5bf-35470fd43204. Accessed July 2022.

[xxiii] Mease PJ, et al. Guselkumab in Biologic-naive Patients with Active Psoriatic Arthritis (DISCOVER-2): A Double-blind, Randomised, Placebo-controlled Phase 3 Trial. The Lancet 2020;395(10230):1126–1136.

[xxiv] Benson JM, et al. Discovery and Mechanism of Ustekinumab: A Human Monoclonal Antibody Targeting interleukin-12 and interleukin-23 for Treatment of Immune-Mediated Disorders. MAbs 2011;3:535–545.

[xxv] Chiricozzi A, et al. Role of IL-23 in the pathogenesis of psoriasis: a novel potential therapeutic target? Expert Opin Ther Targets. 2014;18(5):513-525

[xxvi] Sakkas L et al. New Treatments in Psoriatic Arthritis. Focus on the IL-23/17 Axis. Frontiers in Pharmacology. 2019;10(872):1-8

[xxvii] Gooderham, et al. Shifting the focus – the primary role of IL-23 in psoriasis and other inflammatory disorders. JEADV. 2018;32:1111-1119.