Johnson & Johnson : European Commission Approves Janssen’s TREMFYA®▼ (guselkumab), a First-in-Class Treatment for Active Psoriatic Arthritis (PsA)

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European Commission Approves Janssen's TREMFYA®▼ (guselkumab), a

First-in-Class Treatment for Active Psoriatic Arthritis (PsA)

Guselkumab is the first selective IL-23 p19 subunit inhibitor licensed for both the treatment of PsA and plaque psoriasis

BEERSE, Belgium, November 25, 2020 - The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the European Commission (EC) has approved TREMFYA®▼ (guselkumab) for the treatment of adult patients with active psoriatic arthritis (PsA) who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy.

Guselkumab is the first approved fully human monoclonal antibody that selectively binds to the p19 subunit of interleukin (IL)-23 and inhibits its interaction with the IL-23 receptor. It is already approved for the treatment of patients with moderate to severe plaque psoriasis. IL-23 is an important driver of the progression of inflammatory diseases including psoriasis and PsA, among others.1

PsA is a multifaceted, chronic, immune-mediated inflammatory disease that is progressive and is characterised by debilitating joint damage and inflammation, in addition to enthesitis, dactylitis, axial disease, and the skin lesions associated with psoriasis. The pain, stiffness and swelling of the joints and connective tissue can be severe and cause everyday tasks to become difficult.2,3 In addition, more than half of people with PsA also live with another condition, such as cardiovascular disease, osteoporosis, inflammatory bowel disease or depression.4,5 There is currently no known cure for PsA, and it is estimated that up to a third of the 14 million people living with psoriasis in Europe will go on to develop PsA.6,7

"Psoriatic arthritis is a progressive and debilitating disease and can have a huge impact not only on quality of life, but also on a person's mental health. We welcome the news that guselkumab is now approved for the treatment of psoriatic arthritis," said Jan Koren, President, European Federation of Psoriasis Patient Organisations (EUROPSO)*. "For patients, having more innovative treatment options available that improve the quality of life is good news, which we believe will bring hope to many patients in need of additional treatment options. We must now work to make this treatment accessible to patients across the European Union."

Approval for this new indication is based on results from the DISCOVER-1 and DISCOVER-2 Phase 3 clinical studies, which assessed safety and efficacy of guselkumab 100 mg q4w and q8w in adult patients with active PsA. DISCOVER-1 evaluated 381 participants with active PsA who had an inadequate response to standard therapies, including participants (~30 percent) previously treated with anti-tumour necrosis factor (TNF) alpha biologics.8 DISCOVER-2 included 739 patients who were biologic-naïve only and had an inadequate response to standard therapies.9 Data from these studies was published earlier this year in The Lancet (24-weeks;DISCOVER-1,DISCOVER 2).8,9

• • The published results show that in both studies, at week 24, adult patients with active PsA achieved statistical significance in the primary endpoint of American College of Rheumatology (ACR) 20 percent improvement (ACR20)

response (DISCOVER-1: p<0.001; DISCOVER-2: p<0.001) in both q4w and q8w guselkumab groups (DISCOVER-1: n=255; DISCOVER-2: n=493) vs the placebo groups (DISCOVER-1: n=126; DISCOVER-2: n= 246).10,11

• • In addition, significant improvements in quality of life scores (36-item short-form [SF36] physical component summary) were observed in the guselkumab groups vs the placebo groups in DISCOVER-1 (p<0.001 for both doses); in DISCOVER-2, significant improvements were observed in the q4w guselkumab group vs placebo group (p=0.0056 [q8w, p=0.068]).10,11

• • In DISCOVER 2, inhibition of structural damage progression was measured radiographically and expressed as the mean change from baseline in the total modified van der Heijde-Sharp (vdH-S) score. At week 24, the guselkumab q4w group demonstrated statistically significantly less radiographic progression (p=0.006) and the guselkumab q8w group showed numerically less progression than placebo (p=0.068).11 At week 52, the mean change from baseline in total modified vdH-S score was similar in the guselkumab q8w and q4w groups (mean scores of 0.97 and 1.07 respectively).12

• • In addition, higher Psoriasis Area and Severity Index 75 percent improvement

  (PASI 75), PASI 90 and PASI 100 response rates were observed in the q4w and q8w guselkumab groups vs the placebo groups (in DISCOVER-1, all unadjusted p<0.001 with PASI 100 being p=0.0005 and in DISCOVER-2, all unadjusted p<0.001).8,9

In both studies, guselkumab was well-tolerated, and observed adverse events (AEs) were generally consistent with previous studies of guselkumab and current prescribing information. In DISCOVER-1 and -2, serious adverse events up to week 24 in q4w treatment arms (0 and 3 percent) and q8w treatment arms (3 and 1 percent) were similar to those in the placebo arms (4 and 3 percent). In DISCOVER-2, less than 1 percent of patients experienced serious infections following guselkumab treatment, and no patient experienced serious infections following guselkumab treatment in DISCOVER-1. There were no reported deaths in guselkumab-treated patients and no guselkumab-treated patient had inflammatory bowel disease, opportunistic infections such as tinea or candida, active tuberculosis or anaphylacticor serum sickness-like reactions.8,9

"Guselkumab represents a new treatment option - the first in its class - for patients with psoriatic arthritis, in an area where additional treatment options are needed. The DISCOVER 1 and 2 studies, which this approval is based on, show the potential of guselkumab to improve skin and joint symptoms, including structural joint damage, which are all important elements of sustained management of psoriatic arthritis," said David M. Lee, M.D., Ph.D., Global Therapeutic Area Head, Immunology, Janssen Research & Development, LLC. "Today's approval marks an exciting breakthrough as we continue to reimagine what is possible in how immune- mediated diseases like active PsA are understood and treated."

This marketing authorisation follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), issued on 15 October.

*EUROPSO receives financial support from Janssen to support the organisation's work for people living with psoriatic disease. They have not been compensated for any media work.

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About DISCOVER-1 (NCT03162796; EudraCT 2016-001163-37)13,14

DISCOVER-1 was a randomised, double-blind, multicentre Phase 3 study evaluating the efficacy and safety of guselkumab 100 mg q4w and q8w administered by subcutaneous (SC) injection in participants with active psoriatic arthritis PsA including those previously treated with biologic anti-TNF therapies. DISCOVER-1 evaluated 381 participants, continuing through approximately 1 year.8

The study consisted of a screening phase of up to 6 weeks, a blinded 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-