Tremfya going after psoriatic arthritis

[Fred]

Janssen Pharmaceutical have released phase 3 results of Tremfya (guselkumab) for psoriatic arthritis.

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Janssen Pharmaceutical announced top-line results from the Phase 3 DISCOVER 1 and 2 studies, which evaluated the efficacy and safety of guselkumab compared to placebo in adult patients with active moderate to severe psoriatic arthritis (PsA). Both studies met their primary endpoints of American College of Rheumatology 20 percent improvement (ACR20), and the safety profiles observed for guselkumab in the DISCOVER program were consistent with previous studies of guselkumab and TREMFYA® current prescribing information.

The DISCOVER program comprises the first-ever Phase 3 studies evaluating an IL-23 p19 inhibitor for the treatment of psoriatic arthritis, and data will be presented at upcoming scientific medical meetings. Data from the two DISCOVER studies will serve as the basis of submissions to the U.S. Food and Drug Administration and European Medicines Agency seeking approval of guselkumab as a treatment for psoriatic arthritis, which are anticipated for later this year.

The DISCOVER program consists of DISCOVER-1 and DISCOVER-2, two randomized, double-blind, multicenter Phase 3 studies designed to evaluate efficacy and safety of subcutaneous guselkumab in patients with active PsA compared to placebo. In addition to the primary endpoint of ACR20 response at week 24, multiple secondary endpoints were assessed that included ACR50/70, resolution of soft tissue inflammation (enthesitis and dactylitis), disease activity (DAS-28 CRP), improvement in physical function (HAQ-DI), skin clearance (IGA), and quality of life (SF-36 PCS and MCS). DISCOVER-2 also assessed effect on structural damage (vdH-S) as a key secondary endpoint.

DISCOVER-1 included 381 participants, including participants previously treated with anti-TNF biologics. The study continued through 52 weeks. DISCOVER-2 included 739 bio-naive participants and continued through 100 weeks.

Source: jnj.com

Tremfya (guselkumab)

[Caroline]

Amazing... an IL-23 inhibitor going for Psoriatic Arthritis. That is not very common.

I will try to keep an eye on the publications of Janssen.

[Fred]

Amazing... an IL-23 inhibitor going for Psoriatic Arthritis. That is not very common.

I will try to keep an eye on the publications of Janssen.

They will be here if they are good and reliable.  

[Fred]

Update:

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The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking first-in-class approval of Tremfya (guselkumab) for the treatment of adult patients with active psoriatic arthritis (PsA).

They also expect to submit a marketing application to the European Medicines Agency seeking approval of Tremfya as a treatment for psoriatic arthritis (PsA) before the end of the year.

[jiml]

Looks good Fred and hopefully another choice for psoriatic arthritis sufferers

[Kersty]

I have now been on Tremfya for 14 months.  I was getting an injection every 8 weeks for the first 6 months, then started getting an injection once a month.  My psoriatic arthritis is definitely improved, but strangely, the psoriasis on my hands and feet remains about the same.  Sometimes, it clears for a wee bit (and I do mean a WEE bit), but then comes back with a vengeance.  I guess it's too much to ask for it to fix everything, eh?  (The "eh" injected so that you would know I am a Canadian)

[Fred]

I have now been on Tremfya for 14 months.  I was getting an injection every 8 weeks for the first 6 months, then started getting an injection once a month.  My psoriatic arthritis is definitely improved, but strangely, the psoriasis on my hands and feet remains about the same.  Sometimes, it clears for a wee bit (and I do mean a WEE bit), but then comes back with a vengeance.  I guess it's too much to ask for it to fix everything, eh?  (The "eh" injected so that you would know I am a Canadian)

Good to know it's helping with psoriatic arthritis Kersty, it's one I'm holding in reserve. So thank you for the feedback.

[jiml]

I have now been on Tremfya for 14 months.  I was getting an injection every 8 weeks for the first 6 months, then started getting an injection once a month.  My psoriatic arthritis is definitely improved, but strangely, the psoriasis on my hands and feet remains about the same.  Sometimes, it clears for a wee bit (and I do mean a WEE bit), but then comes back with a vengeance.  I guess it's too much to ask for it to fix everything, eh?  (The "eh" injected so that you would know I am a Canadian)

Hi Kersty the Canadian great that the tremfya is working on the psoriatic Arthritis although it's not doing much for the psoriasis are you using a cream on the psoriasis or just putting up with it ?

It's a shame it hasn't fixed everything for you as the two conditions are related but we can't have everything unfortunately as you say

[KatT]

Now I know which biologic to try next if Cosentyx doesn't work for my PSA!  How much of an improvement did you see?

[Fred]

Update: The National Institute for Health and Care Excellence (NICE) UK have issued final appraisal for Tremfya (guselkumab) to be used  for treating psoriatic arthritis.

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Tremfya can be used for treating active psoriatic arthritis (PsA) in adults who have not responded well to disease-modifying antirheumatic drug (DMARD) therapy or who cannot tolerate them.

The recommendation is only for patients if they have the following:

• Peripheral arthritis with three or more tender joints and three or more swollen joints
     
  
• Moderate to severe psoriasis (a body surface area of at least 3% affected by plaque psoriasis and a Psoriasis Area and Severity Index score greater than 10)
     
  
• Had two conventional DMARDs and at least one biological DMARD