Tremfya Demonstrates Superior Long-Term Efficacy Over Cosentyx in Moderate-to-Severe Plaque Psoriasis: Phase 3 ECLIPSE Trial Results Published in The Lancet

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Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, recently announced that data from the Phase III clinical trial ECLIPSE, which evaluated Tremfya (guselkumab) versus Cosentyx (secukinumab) for the treatment of moderate-to-severe plaque psoriasis, have been published in The Lancet. This study is the first head-to-head comparison of a selective IL-23 inhibitor (Tremfya) and an IL-17 inhibitor (Cosentyx), with results showing thatTremfya is superior to Cosentyx in long-term efficacy。

ECLIPSE is a multicenter, randomized, double-blind, active-controlled study that enrolled 1,048 adult patients with moderate-to-severe plaque psoriasis. Patients were randomly assigned to two groups: the Tremfya group, which received 100 mg subcutaneously at weeks 0 and 4, followed by every 8 weeks thereafter; and the Cosentyx group, which received 300 mg (two 150-mg injections) subcutaneously at weeks 0, 1, 2, 3, and 4, followed by every 4 weeks thereafter. The primary endpoint was the proportion of patients achieving PASI 90 (at least 90% improvement in the Psoriasis Area and Severity Index [PASI] score) at week 48. Six secondary endpoints were assessed at weeks 12 and 48, and safety monitoring continued through week 56.

The results showed that the study met its primary endpoint:At Week 48 of treatment, the proportion of patients achieving PASI 90 response was significantly higher in the Tremfya group than in the Cosentyx group.(84.5% vs 70.0%, p<0.0001). For the first key secondary endpoint (proportion of patients achieving PASI 75 response at both Week 12 and Week 48), the Tremfya group met the non-inferiority criterion compared with the Cosentyx group (85% vs 80%, p<0.0001) but did not demonstrate superiority. Results for other key secondary endpoints were as follows: at Week 12, the proportions of patients achieving PASI 90 response (69% vs 76%) and PASI 75 response (89% vs 92%); at Week 48, the proportions of patients achieving PASI 100 response (58% vs 48%), an Investigator’s Global Assessment (IGA) score of 0 (clear) (62% vs 50%), and an IGA score of 0 or 1 (clear or minimal disease) (85% vs 75%).

The time-varying response curves indicate that Cosentyx has a slightly faster onset of action, whereas Tremfya achieves its maximum response rate at 6 months and maintains it over one year, demonstrating an advantage in terms of the primary endpoint.

Specifically, during the first 12 weeks, a slightly higher proportion of patients in the Cosentyx treatment group achieved PASI 90, PASI 100, and an IGA score of 0 or 1; from weeks 16 to 20, the proportions of patients achieving each response endpoint were similar between the two treatment groups; at week 24 and thereafter, the Tremfya treatment group demonstrated higher proportions of patients achieving each response endpoint compared with the Cosentyx group. These data provide new insights into the comparison of long-term efficacy.

In the study, through Week 44 of treatment, 27 patients (5.1%) in the Tremfya group discontinued treatment, compared with 48 patients (9.3%) in the Cosentyx group. During the study, the observed safety profiles of Tremfya and Cosentyx were consistent with their known safety profiles from respective registration trials and current prescribing information.

Although multiple new therapies are available, many adult patients with moderate-to-severe plaque psoriasis struggle to maintain treatment response. Clinical studies comparing long-term efficacy endpoints, such as ECLIPSE, will help healthcare professionals make more informed decisions when treating this disease.

Tremfya was first approved in July 2017 as the first biologic therapy that selectively blocks IL-23. The drug’s approved indication is plaque psoriasis.

Cosentyx was first approved in December 2014. It is the first fully human monoclonal antibody that specifically targets and inhibits IL-17A, selectively blocking the activity of circulating IL-17A, reducing immune system activity, and improving disease symptoms. To date, the approved indications for this drug are: psoriasis, psoriatic arthritis, and ankylosing spondylitis.

In November last year, the Center for Drug Evaluation (CDE) issued the "Notice on the First Batch of Urgently Needed Overseas New Drugs for Clinical Use," which involved a total of 48 drugs, including Tremfya and Cosentyx. Also included among the new psoriasis treatments were two antibody drugs, brodalumab and ixekizumab, as well as an oral drug, apremilast. Cosentyx was approved by the National Medical Products Administration (NMPA) at the end of March this year; Tremfya submitted its marketing application in late June.

In early June this year, Johnson & Johnson’s another anti-inflammatory drug, Stelara (ustekinumab), was launched in China. This is an IL-12/IL-23 dual-targeted biologic agent used for the treatment of plaque psoriasis, with maintenance therapy requiring only one subcutaneous injection every three months. The concentrated launch of multiple psoriasis drugs indicates that there will inevitably be a fierce competition in this therapeutic field domestically.

Reference Source:

1、The Lancet publishes Phase 3 ECLIPSE study demonstrating superior long-term efficacy (PASI 90 at Week 48) of TREMFYA (guselkumab) vs COSENTYX (secukinumab) in the treatment of adults with moderate to severe plaque psoriasis

2、New Phase 3 data demonstrate superiority of TREMFYA^® (guselkumab) vs Cosentyx^® (secukinumab) in delivering PASI 90 responses in the treatment of moderate to severe plaque psoriasis at week 48

3. First Batch of Overseas New Drugs in Urgent Clinical Need Announced: 40 Global Blockbusters Set to Launch in China

Original Title: Head-to-Head Comparison! Long-Term Efficacy of Johnson & Johnson’s Tremfya in Treating Moderate-to-Severe Plaque Psoriasis is Superior to Cosentyx