On 3 June, Janssen, a subsidiary of Johnson and Johnson (J&J) (NYSE: JNJ), presented new topline safety and efficacy data for its interleukin (IL)-23 inhibitor, Tremfya (guselkumab), at the European League Against Rheumatism (EULAR) 2021 Congress.
The COSMOS Phase IIIb study (NCT03796858) was a randomised, placebo-controlled, post-marketing study investigating the safety and efficacy of Tremfya in adult psoriatic arthritis (PsA) patients with a documented inadequate response to anti-tumour necrosis factor-alpha (anti-TNFα) therapy. In the study, significantly more patients treated with Tremfya showed joint symptom improvement, as measured by the American College of Rheumatology (ACR) 20, and complete skin clearance versus placebo at week 24.
In addition to these key primary and secondary endpoints, Tremfya also demonstrated superior efficacy versus placebo in terms of patient quality of life measures. This post-marketing data in this treatment-refractory population gives J&J the opportunity to position Tremfya early in the PsA treatment algorithm, ahead of the older IL-17 drug class.
These results from the COSMOS trial help to solidify Tremfya’s position in a rapidly saturating biologics market. Key opinion leaders (KOLs) interviewed by GlobalData cited patients who do not respond to TNF inhibitors as a major clinical unmet need, which Tremfya is poised to meet.
Despite promising long-term data, Tremfya still faces strong competition in the field, notably from AbbVie’s IL-23 inhibitor, Skyrizi (risankizumab). Skyrizi is currently pending FDA approval for PsA, and has already been well received by dermatologists for plaque psoriasis (PsO). KOLs interviewed by GlobalData attribute Skyrizi’s success to the fact that AbbVie has competitively contracted with payors to ensure that Skyrizi is easy for physicians to prescribe, which accounts for its stronger sales compared to Tremfya. Improving contracting relationships with payers is, therefore, a key component of ensuring Tremfya’s future commercial success. If the COSMOS clinical trial results, however, lead to guidelines recommending earlier use of Tremfya after TNF inhibitor failure, J&J could see a sales boost.
Over the next decade, Tremfya is expected to have a strong uptake in the PsA market based on J&J’s previous experience marketing Stelara, its IL12/23 inhibitor, in this disease space. Although Stelara’s patent is set to expire in 2023 in the US and Japan, and in 2024 in the five major European markets (5EU) (France, Germany, Italy, Spain, and the UK), J&J will likely be able to preserve its position in the PsA space with Tremfya’s sales.
The current annual cost of therapy (ACOT) for Tremfya is $76,189, a slight premium over other available biologics but slightly cheaper than Skyrizi’s ACOT of $90,740 per year. Despite being launched in a fairly mature market, if J&J is able to contract aggressively with payers and potentially be incorporated earlier in the treatment paradigm, GlobalData expects that Tremfya will still be able to stake a claim to the market. By 2028, Tremfya is expected to net sales of $361m in the US and $577m globally in for PsA.