dm+d

35015511000001103

Refrigerated Storage

TremfyaJanssen-Cilag Ltd

Janssen-Cilag Ltd
Tremfya
Solution for injection in pre-filled pen, 100mg

Contact Janssen-Cilag in all cases where a deviation from the recommended storage conditions has occurred. Refer to the current BNF for company contact details.

4 May 2020
London MI Service

New Medicines

TremfyaActive psoriatic arthritis in adults

Information

Tremfya
Licence extension / variation
Janssen-Cilag
Janssen

Development and Regulatory status

Launched
Launched
Launched
November 2020
Nov 20Approved in EU [16].
Oct 20The additional indication as specified is "alone or in combination with methotrexate (MTX), ... for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy (see section 5.1)" [15].
Oct 20Janssen has announced that the CHMP of the EMA adopted a positive opinion recommending the expanded use of guselkumab for the treatment of adult patients with active psoriatic arthritis [14].
Jul 20Approved in US. [13]
Oct 19Filed in EU for active psoriatic arthritis [8].
Sep 19Janssen submits a supplemental Biologics License Application (sBLA) to the US FDA to seek approval of guselkumab for treatment of adult patients with active psoriatic arthritis (PsA). The submission of the sBLA application was based in the results from the phase III DISCOVER-1 and DISCOVER-2 trials [9].
Jan 19Company plans to file in US & EU in 2019 [5].

Category

Human monoclonal antibody that targets the protein interleukin (IL)-23
Psoriatic arthritis is a chronic inflammatory arthritis that affects about 5-25% of patients with psoriasis. The prevalence varies from 20-420 per 100,000 population across the world, except in Japan where it is 1 per 100,000. In about 80% of cases the presence of psoriasis precedes the onset of psoriatic arthritis [1].
Active psoriatic arthritis in adults
Subcutaneous

Further information

Yes
June 2021

Trial or other data

Jun 21Data from PIIIb COSMOS trial (NCT03796858; EudraCT2018-003214-41) presented at the virtual EULAR meeting, a study evaluating guselkumab in adult patients with active PsA, with demonstrated inadequate response or intolerance to TNF-inhibitors. This multicentre, randomised, double-blind, placebo-controlled trial was initiated in Mar 2019 and recruited 285 patients in Europe, including the UK. Results showed significantly higher proportions of patients treated with guselkumab showed joint symptom improvement (measured by ACR 20) and complete skin clearance vs placebo at week 24, with response rates further increased at 1 year [17]
Mar 20PIII Discover-2 RCT (n=716) reports significantly greater proportions of patients in the guselkumab every 4 weeks group (64%) and every 8 weeks group (64%) achieved ACR20 at 24 weeks vs placebo (33%) [percentage differences vs placebo 31% for both; both p<0.0001) [12].
Mar 20PIII Discover-1 RCT (n=381) is published; it reports ACR20 at week 24 was achieved by significantly greater proportions of patients in the guselkumab every 4 weeks group (59%) and every 8 weeks group (52%) than in the placebo group (22%) [differences vs placebo of 37% and 30% respectively, both p<0.0001] [11].
Nov 19Janssen announces guselkumab meets primary endpoints in PIII DISCOVER-1 and DISCOVER-2 studies. DISCOVER-1 (n=381 including those previously treated with anti-TNFs) showed that 59% patients on guselkumab every four weeks (q4w) and 52 % who received doses at weeks 0, 4 and every eight weeks thereafter (q8w) achieved ACR20 response compared to 22% on placebo (both p<0.001). DISCOVER-2 (n=739 biologic-naïve) showed that at week 24, 64% on guselkumab q4w or q8w respectively, achieved an ACR20 response, compared to 33% on placebo (both p<0.001) [10].
Jun 19Top-line results from PIII DISCOVER 1 and DISCOVER 2 studies have been announced. Both these studies met their primary efficacy end-point of American College of Rheumatology 20 percent improvement (ACR20). Submissions to EMA and FDA will be made based on these data [6,7].
Aug 17PIII Discover-1 (NCT03162796) trial to assess the efficacy and safety of guselkumab in participants with psoriatic arthritis, including those previously treated with up to two anti-TNF alpha agents starts. Primary outcome is ACR20 response at week 24; estimated primary completion date is Oct 19 [3,4].
Jul 17PIII (NCT03158285) study to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA starts. 684 adults will be recruited in sites around the world including US & EU. Primary outcome is ACR20 response at week 24; collection of thse data should complete Feb 20 [2].

Evidence based evaluations

TremfyaModerate to severe ulcerative colitis (UC) - third-line after conventional and biologic therapy

Information

Tremfya
Licence extension / variation
Janssen-Cilag
Janssen

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

Human monoclonal antibody that targets the protein interleukin (IL)-23
Ulcerative colitis is the most common form of inflammatory bowel disease, and the incidence and prevalence is increasing worldwide. The prevalence is estimated at 5-500 per 100,000 worldwide. Incidence estimates range from 0.9 to 24.3 per 100,000 person-years, and prevalence estimates range from 2.4-294 cases per 100,000 people in Europe [1].
Moderate to severe ulcerative colitis (UC) - third-line after conventional and biologic therapy
Subcutaneous injection

TremfyaActive, moderate to severe Crohn's disease

Information

Tremfya
Licence extension / variation
Janssen-Cilag
Janssen

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

Human monoclonal antibody that targets the protein interleukin (IL)-23
UK prevalence is about 145 per 100,000 population [1].
Active, moderate to severe Crohn's disease
Subcutaneous injection

TremfyaChronic plaque psoriasis in children aged 6 to 17 years

Information

Tremfya
Licence extension / variation
Janssen-Cilag
Janssen

Development and Regulatory status

None
Phase III Clinical Trials
Phase III Clinical Trials

Category

Human monoclonal antibody that targets the protein interleukin (IL)-23
The prevalence of psoriasis is estimated to be around 1.3–2.2% in the UK. Psoriasis can occur at any age, although is uncommon in children (0.71%) and the majority of cases occur before 35 years [1].
Chronic plaque psoriasis in children aged 6 to 17 years
Subcutaneous injection

TremfyaPsoriatic arthritis - inhibition of radiographic progression of joint structural damage

Information

Tremfya
Licence extension / variation
Janssen-Cilag
Janssen

Development and Regulatory status

None
Phase III Clinical Trials
Phase III Clinical Trials

Category

Human monoclonal antibody that targets the protein interleukin (IL)-23
Psoriatic arthritis is a chronic inflammatory arthritis that affects about 5-25% of patients with psoriasis. The prevalence varies from 20-420 per 100,000 population across the world, except in Japan where it is 1 per 100,000. In about 80% of cases the presence of psoriasis precedes the onset of psoriatic arthritis [1].
Psoriatic arthritis - inhibition of radiographic progression of joint structural damage
Subcutaneous injection