TREMFYA® (Guselkumab) Pre-filled Pen Approved in China for Adults with Moderate-to-Severe Plaque Psoriasis

BEIJING, Sept. 4, 2020 /PRNewswire/ -- Xian Janssen Pharmaceutical Ltd., the pharmaceutical subsidiary of Johnson & Johnson in China, recently announced that its Stelara^®Pre-filled Pen Injector (Guselkumab Injection, Brand Name: TREMFYA)^®, English generic name: Guselkumab Injection) has been approved by the National Medical Products Administration for use in adult patients with moderate-to-severe plaque psoriasis^[1]。

Tenoja^®It is a fully humanized monoclonal antibody that targets interleukin-23 (IL-23) and inhibits this cytokine, which plays a key role in psoriasis.^{[2] [3]}. As the existing Tenoja^®An upgraded version of the pre-filled syringe, the pre-filled pen injector is a novel single-use device. During injection, patients can fully control the injection speed. The hidden needle and ergonomic pen body design provide convenience for self-injection. Patients must use Tenoya under the guidance and supervision of a physician.^®, may also self-administer the injection after obtaining physician approval and receiving proper training in subcutaneous injection techniques^[1]。

Although patients can self-administer Tremfya injections at home^®, but the traditional subcutaneous injection method still presents some barriers for patients, such as needle phobia, while Taltz^®The approval of prefilled pen injectors provides patients with another convenient and user-friendly option for self-injection. In a recently published Phase 3 randomized, double-blind, placebo-controlled study (ORION), participants completed the Self-Injection Assessment Questionnaire (SIAQ) at Weeks 0, 4, and 12. This questionnaire assessed participant experience with the prefilled pen injector across six domains—sensation of injection, self-image, confidence, pain and skin reactions during or after injection, ease of use of the self-injection device, and satisfaction with self-injection—using a scale from 0 (worst) to 10 (best). At Week 12, the mean score for “satisfaction with self-injection” was 9.18 (with 10 indicating “very satisfied”), and the mean score for “ease of use” was 9.24 (with 10 indicating “very easy”). The mean scores for the other domains at Week 12 ranged from 8.43 to 9.84.^[4]

The ORION study also evaluated patients with moderate-to-severe psoriasis receiving Tenoar^®Efficacy and Safety of Guselkumab Administered via Prefilled Pen Injector. In the study, the proportion of subjects achieving an IGA score of 0 or 1 or a PASI 90 response at Week 16 in the guselkumab group (80.6% and 75.8% for the two endpoints, respectively; p<0.001) was significantly higher than that in the placebo group (0% for both endpoints). The proportion of subjects achieving an IGA score of 0 at Week 16 was significantly higher in the guselkumab group than in the placebo group (56.5% vs. 0%; p<0.001). The proportion of subjects achieving a PASI 100 response at Week 16 was significantly higher in the guselkumab group than in the placebo group (50.0% vs. 0%; p<0.001).^[5]

Psoriasis is a chronic, immune-mediated inflammatory disease characterized by scaly, painful plaques or skin lesions on the surface of the skin. There are over 125 million people worldwide living with psoriasis.^[5], with 6.5 million patients in China^[6]. Plaque psoriasis is the most common form of psoriasis, accounting for more than 80% of all cases^[6], among whom over 50% of patients had moderate-to-severe plaque psoriasis^[7]。

Asgar Rangoonwala, President of Xian Janssen, stated, “We remain committed to providing innovative biologics and novel solutions, such as Tremfya, to patients with autoimmune diseases, including those with psoriasis.”^®Prefilled pen injector. We will continue to collaborate closely with relevant authorities to improve drug accessibility and make unremitting efforts to help patients with moderate-to-severe plaque psoriasis return to normal lives.”

References

[1] TREMFYA Product Information

[2] Tang C. et al. Interleukin-23: as a drug target for autoimmune inflammatory diseases, Immunology. 2012 Feb; 135(2): 112–124.

[3] Nawas Z. et al. A Review of Guselkumab, an IL-23 Inhibitor, for Moderate-to-Severe Plaque Psoriasis. Skin Therapy Lett. 2017 Mar;22(2):8-10.

[4] Ferris LK et al. Efficacy and safety of guselkumab, administered with a novel patient-controlled injector (One-Press), for moderate-to-severe psoriasis: results from the phase 3 ORION study. J Dermatolog Treat. 2020 Mar;31(2):152-159

[5] Reich K, Armstrong AW, Foley P, et al. Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the treatment of patients with moderate to severe psoriasis with randomized withdrawal and retreatment: Results from the phase III, double-blind, placebo- and active comparator-controlled VOYAGE 2 trial. J Am Acad Dermatol. 2017;76(3):418-431

[6] Ding X, Wang T, Shen Y, et al. Prevalence of psoriasis in China: a population-based study in six cities. Eur J Dermatol. 2012;22(5):663-7.

[7] Kun Chen,et al. Oncotarget. 2017 Jul 11; 8(28): 46381–46389

About Tenoya^{® [1]}

Tremfya^® (Guselkumab Injection) It is a fully human monoclonal antibody targeting interleukin-23 (IL-23) developed by Janssen. IL-23 is a cytokine that plays a key role in the pathogenesis and progression of psoriasis. Currently, Tremfya^®Tremfya®Approved in the United States, Canada, the European Union, Japan, and other countries and regions for the treatment of adult patients with moderate to severe plaque psoriasis. On December 26, 2019, it was approved in China for adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy.^®The recommended dosage is 100 mg administered subcutaneously at Week 0 and Week 4, followed by the same dose every 8 weeks for maintenance. Patients may self-administer the injection under physician approval and after receiving proper training in subcutaneous injection techniques, in accordance with the methods provided in the package insert.

AboutORION Research^[7]

ORION is a Phase 3, randomized, double-blind, placebo-controlled study evaluating Tremfya^®Efficacy, Safety, Pharmacokinetics, Immunogenicity, Usability, and Acceptability of the Prefilled Pen Injector. In this study, 78 subjects were randomized to receive guselkumab (100 mg, administered at Weeks 0 and 4, and every 8 weeks thereafter) or placebo. The baseline characteristics of the randomized subjects were similar to those observed in VOYAGE 1 and VOYAGE 2. The co-primary endpoints were the proportion of subjects achieving an Investigator’s Global Assessment (IGA) score of 0 or 1 at Week 16 and the proportion of subjects achieving a Psoriasis Area and Severity Index (PASI) 90 response at Week 16. Secondary endpoints included the proportion of subjects achieving an IGA score of 0 at Week 16 and the proportion of subjects achieving a PASI 100 response at Week 16.

The proportion of subjects achieving an IGA score of 0 or 1 or a PASI 90 response at Week 16 was significantly higher in the guselkumab group (80.6% and 75.8%, respectively; p<0.001) than in the placebo group (0% for both endpoints). The proportion of subjects achieving an IGA score of 0 at Week 16 was significantly higher in the guselkumab group than in the placebo group (56.5% vs. 0%; p<0.001). The proportion of subjects achieving a PASI 100 response at Week 16 was significantly higher in the guselkumab group than in the placebo group (50.0% vs. 0%; p<0.001).

At Weeks 0, 4, and 12, subject experience with the prefilled pen injector was assessed using the validated Self-Injection Assessment Questionnaire (SIAQ). The SIAQ evaluates responses across six domains: sensation of injection, self-image, confidence, pain and skin reactions during or after injection, ease of use of the self-injection device, and satisfaction with self-injection, on a scale from 0 (worst) to 10 (best). At Week 12, the mean score for “satisfaction with self-injection” was 9.18 (10 indicating “very satisfied”), and the mean score for “ease of use” was 9.24 (10 indicating “very easy”). The mean scores for the other domains at Week 12 ranged from 8.43 to 9.84.

About Xian Janssen

Xian Janssen Pharmaceutical Ltd. is the pharmaceutical subsidiary of Johnson & Johnson in China. At Xian Janssen, we are dedicated to creating a world free of disease. We are continually inspired by our goal to prevent, interrupt, and treat diseases in newer and better ways. We converge advanced concepts and pursue scientific achievements with promising prospects. We are Xian Janssen. Together with the world, we forge health.

For more information about Xian Janssen Pharmaceutical Ltd., please visit our website:www.xian-janssen.com.cn, or follow our WeChat official account: Xian Janssen.

Cautionary Note Regarding Forward-Looking Statements

This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding TREMFYA^®(guselkumab injection). Readers are cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could differ materially from the expectations and projections of Xian Janssen Pharmaceutical Ltd., any other Janssen pharmaceutical company, and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product development, including uncertainty regarding clinical success and obtaining regulatory approval; uncertainty regarding commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety issues resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 30, 2018 (including the sections entitled “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors”), in the Company’s most recently filed Quarterly Report on Form 10-Q, and in the Company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov and www.jnj.com, or upon request from Johnson & Johnson. Neither Janssen nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

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