The effectiveness of Tremfya ^® is maintained for at least five years in more than 80% of patients ¹ which exceeds the capabilities of existing drugs for the treatment of psoriasis ^2,3,4

MOSCOW, February 4, 2021 – Janssen, a pharmaceutical division of Johnson & Johnson LLC, announces that Tremfya (guselcumab), a drug intended for the treatment of moderate to severe plaque psoriasis, has been included in the list of essential and essential drugs (VED) from 1 January 2021.

Psoriasis is a severe systemic disease that has a serious negative impact primarily on the quality of life of patients ⁵ . The most common form of psoriasis is plaque psoriasis, usually manifesting as thick, red, or inflamed skin covered in silvery scales called plaques ⁶ . The undulating nature of the course of the disease leads to the fact that even with the disappearance of plaques, many patients continue to live in fear of their new appearance ⁷ .

Guselcumab ^® is a biologic agent of the interleukin 23 inhibitor class for the treatment of moderate to severe plaque psoriasis in adult patients in whom systemic therapy is indicated ⁸ . Guselcumab is a fully human monoclonal antibody with low immunogenicity and a favorable safety profile. More than 80% of patients achieved and maintained near-complete skin clearance within five years of treatment with Guselcumab ⁹ .

“Inclusion of the drug in the list of Vital and Essential Drugs is an important step for Russian patients with severe and moderate psoriasis, since the use of guselkumab prevents the disability of young, able-bodied and socially active members of society, and also solves an important social problem for patients: it improves the quality of life and contributes to the preservation of working capacity ^{9,2,10,11,12,13,14,15} “,” comments Katerina Pogodina , Janssen Russia and CIS Managing Director, General Director of Johnson & Johnson LLC.

The drug was registered in Russia in August 2019. Guselcumab ^® is designed to improve the quality of life of patients with severe forms of psoriasis, helping them to maintain their ability to work and social activity. It is the first biologic that selectively blocks interleukin (IL)-23, a key cytokine in the immune system’s inflammatory response in psoriasis ^16,17,18 . Guselcumab therapy consists of two initiating injections at weeks 0 and 4 followed by maintenance injections once every 8 weeks ¹ .

“Psoriasis is not just a skin disease, but a systemic disease that affects the state of internal organs and the nervous system as well. Due to the presence of systemic inflammation, the risk of death in such patients from cardiovascular diseases increases by 1.5 times, and the risk of developing myocardial infarction – by 3 times. The life expectancy of patients with psoriasis is on average 5-7 years less than in the general population ^19.20.21 . Being one of the most effective drugs registered in Russia against psoriasis ^2,6,14 , Guselkumab ^® suppresses systemic inflammation, thereby reducing the risk of developing cardiovascular diseases, psoriatic arthritis and subsequent disability, which improves the quality and life expectancy of patients. With the inclusion of Guselkumab in the list of vital and essential drugs, innovative therapy will become available to the largest number of patients who really need it” , – comments Konstantin Igorevich Raznatovsky , Doctor of Medical Sciences, Professor, Chief Dermatovenereologist and Cosmetologist of the Health Committee of the Government of St. Petersburg, Chief Dermatovenereologist and Cosmetologist of the Northwestern Federal District, Head of the Department of Dermatovenereology, North-Western State Medical University named after I. I. Mechnikov.

Direct comparative studies have shown that Guselkumab ^® outperforms current standards in the treatment of psoriasis and demonstrates high efficacy in completely and almost completely clearing the skin of psoriatic manifestations ^1,2,4,16 . In addition, the use of guselcumab is not associated with the risk of oncological and cardiovascular diseases, severe opportunistic infections, as well as the reactivation of tuberculosis and the development of inflammatory bowel diseases ¹ .

“The most important indicator of the effectiveness of treatment is the long-term preservation of the effect achieved and the long-term retention of patients on therapy,” the expert believes – According to the study, four years after the start of treatment, the largest proportion of patients remain on guselkumab therapy compared to drugs of previous generations. At the same time, during this time, the vast majority (84%) ^22,23,24,25 patients receiving Guselcumab® maintain the achieved response, characterized by the absence of disease recurrence. It is also important to note that Guselcumab® is characterized by a favorable safety profile, which makes it possible to use it for patients with cardiovascular diseases, IBD, multiple sclerosis and latent tuberculosis, in contrast to a number of drugs of other classes ^{1, 26}

Cost of an annual course of treatment with Tremfya ^® lower or comparable to the cost of therapy with other modern GIBP ²⁷ .

According to information for 2018, in Russia, the prevalence of psoriasis among the entire population was 242.4, the incidence was 66.5 per 100,000 population ²⁸ . Between 2011 and 2018, the increase in the prevalence of psoriasis was 11% ⁶ .

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About Guselcumab

0008 ^® has been approved by the European Medicines Agency based on data from three phase III clinical trials ²⁹ . The VOYAGE 1 and 2 trials comparing Guselkumab ^® with placebo and Adalimumab ^® showed a high level of skin clearing after just 16 weeks of therapy with a 90% reduction in the Psoria Prevalence and Severity Index value for (PASI 90) in 73.3% and 70.0% of patients treated with Guselcumab ^® (p < 0.001 versus placebo) ^2.3 . By week 24 of therapy, PASI 90 was achieved in 80.2% and 75.2% of patients treated with Guselcumab ^® , compared with 49.7% and 46.8% of patients treated with Adalimumab ^® 900 11 respectively (P < 0.001) ^2.3 .

The NAVIGATE study included patients who did not achieve clear or near clear skin [IGA score of 0 or 1] by week 16 of treatment with Stelara ^® (ustekinumab), and who were then switched to either guselcumab therapy or remained on ustekinumab ⁴ therapy. Among patients switched to guselkumab, the proportion of patients who achieved clear or near clear skin (IGA 0/1) or achieved at least a 2-point improvement in IGA score between weeks 28 and 40 (relative to week 16) was statistically significantly higher compared to the ustekinumab group (1. 5 vs. 0.7; P < 0.001) ⁴ .

In a head-to-head comparison study of the efficacy of guselcumab and secukinumab, the proportion of patients who achieved PASI 90 at 48 weeks of therapy was higher in the guselcumab group compared to patients treated with secukinumab (84% and 70%, respectively, p < 0.0001) ^{30 9001 0 .}

Guselcumab’s clinical trial program for psoriasis showed no trend towards increased risk of malignancy, cardiovascular disease, or serious infections, including TB and reactivation of latent TB with the drug ^{2, 3 , 4} .

About Janssen, Johnson & Johnson Pharmaceutical Companies

At Janssen, we are creating a future where disease is a thing of the past. We are the Pharmaceutical Companies of Johnson & Johnson and we are working hard to make this future a reality for patients around the world. We defeat diseases with advanced science. Inventing how to help those who need help. We heal hopelessness with human warmth.

We work in areas of medicine where we can make the most difference: cardiovascular disease, immune-mediated and metabolic diseases, infectious diseases and vaccines, diseases of the central nervous system, oncology, pulmonary arterial hypertension.

Find out more at janssen.com. Follow: twitter.com/JanssenGlobal.

1. Griffiths et al. Poster Presentation Coastal Dermatology Symposium. 2020, October 15-16 ^th .

2. Blauvelt A. et al. J Am Acad Dermatol 2017;76:405-417.

3. Langley R. G. et al. Br J Dermatol 2018;178:114−123.

4. Reich, Kristianet al The Lancet. 10.1016/S0140-6736(19)31773-8.

5. Kerdel F. The Importance of Early Treatment in Psoriasis and Management of Disease Progression. J Drugs Dermatol . 2018;17(7):737–742.

6. National Institute of Arthritis and Musculoskeletal and Skin Disorders. NIH Medline Plus. 2003;12(1):20–21.

7. US Food and Drug Administration. 2016. Available at: https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM529856.pdf. Accessed January 2021.

8. State Register of Medicines [Electronic resource]. Available at: http://grls.rosminzdrav.ru/Grls_View_v2.aspx?routingGuid=06e7fa3a-e993-4bad-aa90-f28b2de029d3&t= The link is active as of 02/03/2021.

9. Reich K. et al. Presented at EADV 2017. Poster P1796.

10. Munir F. et al. Occup Med 2008; 58: 310–311 2. Blauvelt A, et al . J Am Acad Dermatol 2017;76:405−417

11. Griffiths C.E.M. et al. Presented at EADV 2017, Geneva, Switzerland

12. Griffiths C.E.M. et al. J Drugs Dermatol 2018;17:826–832

13. Griffiths C.E.M. et al. Presented at Fall Clinical Dermatology. Las Vegas: United States of America; 2018.

14. Reich K. et al. J Am Acad Dermatol 2017;76:418-431.

15. Langley R. G. et al . Br J Dermatol 2018;178:114–123.

16. Blauvelt A., Papp K. A. et al. J Am Acad Dermatol 2017;76(3):405–417.

17. Reich K and Armstrong A.W et al. J Am Acad Dermatol 2017;76(3):418–431.

18. Puig L. Guselkumab for the treatment of adults with moderate to severe plaque psoriasis. Expert Rev Clin Immunol . 2019;15(6):589–597.

19. Fernández-Armenteros J. M. et al. J EurAcadDermatolVenereol. June 28, 2018. DOI: 10.1111/jdv.15159.

20. Mehta N. et al. Am J Med. 2011;124:775e1–6.

21. Ahlehoff O. et al. Eur Heart J. 2012;33:2054–64.

22. Augustin M, et al. EADV 2020 P1299

23. Warren RB, Smith CH, Yiu ZZN J Invest Dermatol. 2015;135(11):2632–2640

24. Egeberg A, Bryld LE, Skov L. J Am Acad Dermatol. 2019;81(1):173–178

25. Griffiths C.E.M., et al. Fall Clinical Dermatology Conference; October 17-20, 2019

0003

State Register of Maximum Selling Prices. Electronic resource: https://grls.rosminzdrav.ru/pricelims.aspx Access date 25.01.21

28. Kubanov A. A., Bogdanova E. V. Organization and results of medical care in the field of “dermatovenereology” in the Russian Federation. Results of 2018. Journal of Dermatology and Venereology . 2019;95(4):8–23.

29. The European Medicines Agency (EMA). [Electronic resource] Available at: https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-tremfya-ii-17_en.pdf. Accessed: 02/03/2021.

30. Reich K., Armstrong A. W., Langley R. G. et al. Guselkumab versus secukinumab for the treatment of moderate-to-severe psoriasis (ECLIPSE): results from a phase 3, randomized controlled trial. Lancet . 2019;394(10201):831–839. 394. DOI: 10.1016/S0140-6736(19)31773-8.

This is the first biologic that selectively blocks interleukin (IL)-23, a key cytokine in the immune system’s inflammatory response in psoriasis. Guselcumab therapy consists of two initiating injections at weeks 0 and 4 followed by maintenance injections once every 8 weeks.
“The inclusion of guselcumab in the list of essential drugs is an important event for Russian patients with severe and moderate psoriasis who are indicated for systemic therapy. We hope that the drug will now be available to the largest number of patients for whom it can bring the maximum benefit. The decision of the commission of the Ministry of Health of the Russian Federation to include the drug in the list guarantees patients to receive this innovative and effective therapy, which is necessary to improve their quality of life, as part of the list of vital and essential drugs (VED) and the list of drugs for certain categories of citizens (ONLS). The decision of the commission once again confirmed that our drug shows clinically significant results, is characterized by a favorable safety profile and is necessary for Russian patients,” comments Katerina Pogodina, Managing Director of Janssen Russia and the CIS, General Director of Johnson & Johnson LLC.

According to information for 2018, in Russia, the prevalence of psoriasis among the entire population was 242.4, the incidence was 66.5 per 100 thousand population [1]. Between 2011 and 2018, the increase in the prevalence of psoriasis was 11%.
“Guselcumab has already established itself as a drug with a clinically significant result in the fight for a high quality of life in patients with psoriasis, this severe, disabling, socially significant disease. Thanks to guselcumab therapy, a high level of skin cleansing is achieved, the area of ​​damage and the severity of psoriasis are significantly reduced, and the quality of life is significantly improved both in bionaive patients and in patients with insufficient effectiveness of previous therapy with genetically engineered biological preparations [2]. The effectiveness of the drug is maintained for at least 4 years in more than 80% of patients [3]. The use of Guselcumab is not associated with an increased risk of oncological and cardiovascular diseases, severe opportunistic infections and reactivation of tuberculosis, and the development of inflammatory bowel diseases. Now that the drug has been recommended by the commission of the Ministry of Health of the Russian Federation for inclusion in the lists of vital and essential drugs and ONLS, patients can count on a broad provision of effective treatment, the therapeutic response to which persists for a long time, ”comments Nikolai Nikolaevich Potekaev, chief freelance specialist in dermatovenereology and cosmetology of the Ministry of Health of Russia, director of the Moscow Scientific and Practical Center for Dermatovenereology and Cosmetology of the Moscow Health Department, head of the department skin diseases and cosmetology N.I. Pirogov of the Ministry of Health of Russia”, Doctor of Medical Sciences, Professor.

About Guselcumab
In 2017, Tremfya was approved by the European Medicines Agency based on data from three Phase III clinical trials [4]. The VOYAGE 1 and 2 trials, which compared guselcumab with placebo and adalimumab, showed a high level of skin clearing after 16 weeks of
treatments with a 90% reduction in the Psoriasis Prevalence and Severity Index (PASI 90) score in 73. 3% and 70.0% of patients treated with guselcumab (compared to placebo). By week 24 of therapy, PASI 90 was observed in 80.2% and 75.2% of patients treated with guselkumab compared with 49.7% and 46.8% of patients treated with adalimumab, respectively. The stable result of therapy with guselcumab persists for a long time: after 3 years, 97.4% of patients have a response according to the PASI 75 index (significant skin cleansing) [5].
The NAVIGATE study included patients who did not achieve clear or near clear skin (IGA score of 0 or 1) by week 16 of treatment with Stelara® (ustekinumab) and who were then switched to either guselkumab or remained on ustekinumab. Among patients switched to guselkumab therapy, the proportion of patients who achieved complete or near complete skin clearance (IGA 0/1) or achieved at least a 2-point improvement in the IGA score between weeks 28 and 40 (relative to week 16) was statistically significantly greater compared to the ustekinumab group (1.5 vs 0. 7).
In a head-to-head comparison study of the efficacy of guselcumab and secukinumab, it was shown that the proportion of patients who achieved PASI 90 at 48 weeks from the start of therapy was higher in the guselcumab group compared with patients treated with secukinumab (84% and 70%, respectively) [6].
Guselcumab’s psoriasis clinical trial program did not show clear evidence of an increased risk of malignant neoplasms, cardiovascular disease, or serious infections, including tuberculosis and reactivation of latent tuberculosis, while taking the drug.

Links

1. Kubanov A. A., Bogdanova E. V. Organization and results of medical care in the field of “dermatovenereology” in the Russian Federation. Results of 2018. Bulletin of dermatology and venereology. 2019;95(4):8–23.
2. C.E.M. Griffith et al. Clinical response after guselkumab treatment among adalimumab PASI 90 nonresponders: Results from the VOYAGE 1 and 2 trials Journal of the American Academy of Dermatology, Volume 79, Issue 3, AB78
3. Griffiths C.
   

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