Expert Consensus: Main Risk Factors for Poor Prognosis in COVID-19 and the Implications for Targeted Measures against SARS-CoV-2.
作者: Francisco Javier Candel ; Pablo Barreiro ; Miguel Salavert ; Alfonso Cabello ; Mario Fernández-Ruiz ; Pedro Pérez-Segura ; Jesús San Román ; Juan Berenguer ; Raúl Córdoba ; Rafael Delgado ; Pedro Pablo España ; Ignacio Alberto Gómez-Centurión ; Juan María González Del Castillo ; Sarah Béatrice Heili ; Francisco Javier Martínez-Peromingo ; Rosario Menéndez ; Santiago Moreno ; José Luís Pablos ; Juan Pasquau ; José Luis Piñana ; On Behalf Of The Modus Investigators Adenda
The clinical evolution of patients infected with the Severe Acute Respiratory Coronavirus type 2 (SARS-CoV-2) depends on the complex interplay between viral and host factors. The evolution to less aggressive but better-transmitted viral variants, and the presence of immune memory responses in a growing number of vaccinated and/or virus-exposed individuals, has caused the pandemic to slowly wane in virulence. However, there are still patients with risk factors or comorbidities that put them at risk of poor outcomes in the event of having the coronavirus infectious disease 2019 (COVID-19). Among the different treatment options for patients with COVID-19, virus-targeted measures include antiviral drugs or monoclonal antibodies that may be provided in the early days of infection. The present expert consensus is based on a review of all the literature published between 1 July 2021 and 15 February 2022 that was carried out to establish the characteristics of patients, in terms of presence of risk factors or comorbidities, that may make them candidates for receiving any of the virus-targeted measures available in order to prevent a fatal outcome, such as severe disease or death. A total of 119 studies were included from the review of the literature and 159 were from the additional independent review carried out by the panelists a posteriori. Conditions found related to strong recommendation of the use of virus-targeted measures in the first days of COVID-19 were age above 80 years, or above 65 years with another risk factor; antineoplastic chemotherapy or active malignancy; HIV infection with CD4+ cell counts < 200/mm3; and treatment with anti-CD20 immunosuppressive drugs. There is also a strong recommendation against using the studied interventions in HIV-infected patients with a CD4+ nadir <200/mm3 or treatment with other immunosuppressants. Indications of therapies against SARS-CoV-2, regardless of vaccination status or history of infection, may still exist for some populations, even after COVID-19 has been declared to no longer be a global health emergency by the WHO.
Comparative evaluation of efficacy, pharmacodynamics, and safety of Hetero's adalimumab (Mabura®, Hetero Biopharma Ltd.) and reference adalimumab (Humira®, Abbvie Inc.) in patients with active rheumatoid arthritis on concomitant methotrexate therapy.
Our study aimed to compare efficacy and safety of Hetero's adalimumab (Mabura®, Hetero Biopharma Limited) versus reference adalimumab (Humira®, Abbvie Inc.) in Indian patients with active rheumatoid arthritis (RA) concomitant on methotrexate (MTX) therapy.
Patients (n = 168) were randomized (2:1) to receive either test or reference product for 24 weeks with concomitant MTX. Proportion of patients achieving American College of Rheumatology 20 (ACR20) criteria at week 12 was the primary endpoint. Changes in Disease Activity Score of 28 joints-C-reactive protein (DAS28-CRP), Health Assessment Questionnaire-Disability Index (HAQ-DI), and patients achieving ACR20 at week 24, ACR50/70 at weeks 12 and 24 were secondary endpoints.
Patients achieving ACR20 responses with test (96.43%) were similar to reference (96.43%) in intention-to-treat (ITT) analysis at week 12. Proportional difference (PD) between groups (PD [95% CI] 0.0 [- 6.0, 6.0], p = 1.000) for ACR20 at week 12 for ITT analysis showed lower limit of the two-sided 95% CI was above the pre-specified noninferiority margin of - 15%. Similar trend in PP analysis (PD [95% CI] 0.0 [- 0.03, 0.07], p = 1.000), confirmed therapeutic equivalence. No significant difference was noted between arms for patients attaining ACR20 at week 24 and ACR50/70 at weeks 12 and 24 (all p > 0.05). DAS28-CRP and HAQ-DI were similar between groups. Total of 54 patients reported 88 AEs during the study. Out of these, 60 AEs were reported in 34 patients with Hetero-Adalimumab and 28 AEs were reported in 20 patients with Reference-Adalimumab. Total two patients, one in each group reported two serious adverse events (Sinusitis and Viral infection) during the study and resolved completely. No deaths and no life threatening AEs were reported.
Results demonstrated Hetero's adalimumab is as effective and well tolerated as reference adalimumab in patients with active RA concomitantly on MTX therapy.
DUBLIN, Nov. 29, 2022 /PRNewswire/ -- The "Adalimumab, Infliximab and Etanercept Biosimilars Global Market Report 2022: By Product, By Application, By Distribution" report has been added to
The global adalimumab, infliximab and etanercept biosimilars market is expected to grow from $3.10 billion in 2021 to $4.76 billion in 2022 at a compound annual growth rate (CAGR) of 53.4%. The market is expected to reach $18.61 billion in 2026 at a CAGR of 40.6%.
The main types of products in adalimumab, infliximab and etanercept biosimilars are adalimumab biosimilars (exemptia, mabura, hyrimoz, hadlima, abrilada, others), infliximab biosimilars (inflectra, renflexis, ixifi, avsola) and cipleumab (erelzi, eticovo). Adalimumab is a biological drug that works on the immune system to lessen inflammation. The different applications include crohn's disease, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, ankylosing spondylitis, plaque psoriasis, others and is distributed through various channels such as hospital pharmacies, retail pharmacies, online pharmacies.
The patent expiry of branded drugs allows biosimilars to enter the market. For instance, In United States FDA approved inflectra, developed by Hospira (a Pfizer Inc company) for the treatment of various autoimmune diseases such as rheumatoid arthritis, adult ulcerative colitis, plaque psoriasis, after the patent expiry of branded drug Remicade.
Similarly, Amgen's Enbrel had its patent expired in the EU and with the expiry of the patent, Benepali (a biosimilar of Enmbrel) was approved by the European Commission. Humira's patent expired and its biosimilars were made available in the market. FDA has recently (July 2020) approved Hulio, the sixth biosimilar of Humira. Therefore, the patent expiry of branded biologic drugs such as Humira, Enbrel and Remicade will drive the biosimilar market.
The patent extension of Humira (adalimumab) will hamper the Humira biosimilar market. The patent extension is a strategy to compete with generic and biosimilar products after patent termination. For instance, the patents of Humira, the branded biologic drug manufactured by AbbVie, in the US and EU.
AbbVie obtained Supplementary Protection Certificates (SPCs) that provided protection in Europe. AbbVie received a patent extension for Humira till 2023 in the US. In pursuit of patent extension, AbbVie also had settlements with Amgen, Samsung Bioepis, and Mylan to protect Humira sales in the United States. The patent extension of Humira is anticipated to hinder its biosimilars market growth.
The brand versions of biosimilar drugs are of high costs, which are now being replaced with biosimilar versions upon their patent's expiry. The cost of branded biologic drugs almost doubled in recent years. For instance, the cost of Humira, the top-selling drug, increased to more than $72,000 in 2020.
The shift to low-cost biosimilar drugs is mainly because there are no clinically relevant differences in safety and efficacy between the biosimilars and originator biologics. The Danish health care system switched almost entirely to adalimumab biosimilars after the patent on the original adalimumab product, Humira, expired in October 2018. The switch to biosimilars led to an 82% decrease in costs for the medication.
1) By Product: Adalimumab Biosimilars (Exemptia, Mabura, Hyrimoz, Hadlima, Abrilada, Others); Infliximab Biosimilars (Inflectra, Renflexis, Ixifi, Avsola); Cipleumab (Erelzi, Eticovo)
2) By Application: Crohn'S Disease; Psoriatic Arthritis; Rheumatoid Arthritis; Ulcerative Colitis; Ankylosing Spondylitis; Plaque Psoriasis; Others
3) By Distribution Channel: Hospital Pharmacies; Retail Pharmacies; Online Pharmacies
Key Topics Covered:
1. Executive Summary
2. Adalimumab, Infliximab and Etanercept Biosimilars Market Characteristics
3. Adalimumab, Infliximab and Etanercept Biosimilars Market Trends And Strategies
4. Impact Of COVID-19 On Adalimumab, Infliximab and Etanercept Biosimilars
5. Adalimumab, Infliximab and Etanercept Biosimilars Market Size And Growth
6. Adalimumab, Infliximab and Etanercept Biosimilars Market Segmentation
7. Adalimumab, Infliximab and Etanercept Biosimilars Market Regional And Country Analysis
8. Asia-Pacific Adalimumab, Infliximab and Etanercept Biosimilars Market
9. China Adalimumab, Infliximab and Etanercept Biosimilars Market
10. India Adalimumab, Infliximab and Etanercept Biosimilars Market
11. Japan Adalimumab, Infliximab and Etanercept Biosimilars Market
12. Australia Adalimumab, Infliximab and Etanercept Biosimilars Market
13. Indonesia Adalimumab, Infliximab and Etanercept Biosimilars Market
14. South Korea Adalimumab, Infliximab and Etanercept Biosimilars Market
15. Western Europe Adalimumab, Infliximab and Etanercept Biosimilars Market
16. UK Adalimumab, Infliximab and Etanercept Biosimilars Market
17. Germany Adalimumab, Infliximab and Etanercept Biosimilars Market
18. France Adalimumab, Infliximab and Etanercept Biosimilars Market
19. Eastern Europe Adalimumab, Infliximab and Etanercept Biosimilars Market
20. Russia Adalimumab, Infliximab and Etanercept Biosimilars Market
21. North America Adalimumab, Infliximab and Etanercept Biosimilars Market
22. USA Adalimumab, Infliximab and Etanercept Biosimilars Market
23. South America Adalimumab, Infliximab and Etanercept Biosimilars Market
24. Brazil Adalimumab, Infliximab and Etanercept Biosimilars Market
25. Middle East Adalimumab, Infliximab and Etanercept Biosimilars Market
26. Africa Adalimumab, Infliximab and Etanercept Biosimilars Market
27. Adalimumab, Infliximab and Etanercept Biosimilars Market Competitive Landscape And Company Profiles
28. Adalimumab, Infliximab and Etanercept Biosimilars Pipeline Analysis
29. Key Mergers And Acquisitions In The Adalimumab, Infliximab and Etanercept Biosimilars Market
30. Adalimumab, Infliximab and Etanercept Biosimilars Market Future Outlook and Potential Analysis
Hetero Drugs Ltd.
Emcure Pharmaceuticals Ltd.
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