COVID‐19 in DMARD‐treated patients with inflammatory rheumatic diseases: Insights from an analysis of the World Health Organization pharmacovigilance database

Dernoncourt, A.; Schmidt, J.; Duhaut, P.; Liabeuf, Sophie; Gras‐Champel, Valérie; Masmoudi, Kamel; Bennis, Youssef; Batteux, Benjamin

doi:10.1111/fcp.12695

Cited by 15 publications

(8 citation statements)

References 58 publications

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“…Согласно данным C19-GRA, в период пандемии COVID-19 (с марта 2020 г. по апрель 2021 г) РТМ и иЯК показали статистически значимую связь с тяжелым течением COVID-19; для препаратов из группы ирИЛ-6 такая связь не выявлена [21]. В докладе Фармаконадзора ВОЗ у пациентов с РА отмечалась обратная связь терапии ирИЛ-6 (тоцилизумабом) с тяжестью течения COVID-19, что подтверждает высокую безопасность применения таких препаратов у пациентов с ИВРЗ [12].…”

Section: Discussionunclassified

“…По результатам отчета Фармаконадзора Всемирной организации здравоохранения (ВОЗ), показан потенциально лучший профиль безопасности для ирИЛ6 и иЯК [12]. По данным ряда исследований, пациенты, получавшие ГИБП, особенно иФНО-α, реже нуждались в госпитализации [5].…”

Section: Introductionunclassified

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Results of a 12-week open-label, non-interventional study of the efficacy and safety of olokizumab therapy in patients with rheumatoid arthritis after switching from anti-B-cell therapy during the SARS-CoV-2 pandemic

Akimova¹,

Banshchikova²,

Сизиков

et al. 2023

Naučno-praktičeskaâ revmatologiâ

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The COVID-19 pandemic has significantly changed the understanding of the safety profile of therapies for immunoinflammatory rheumatic diseases (IRDs). This is primarily due to the negative impact of a number of basic anti-inflammatory drugs (DMARDs) and biological DMARDs on the course and outcomes of a new coronavirus infection. A number of studies have shown that anti-B-cell therapy (rituximab) gave a statistically significant increase in the risk of severe COVID-19 and an increase in mortality. At the same time, the analysis of real clinical practice data dictated the need to establish a number of restrictions on the use of certain classes of biological DMARDs and to search for alternative therapy programs to maintain control over disease activity.Purpose of the study – to evaluate the efficacy and safety of the drug Artlegia® (olokizumab), solution for subcuta neous injection, 160 mg/ml – 0.4 ml, manufactured by R-Pharm JSC, Russia) for the treatment of patients with rheuma toid arthritis in real clinical practice after switching with rituximab during the COVID-19 pandemic.Materials and methods. The study included 14 patients with a confirmed diagnosis of rheumatoid arthritis (RA), who were previously on rituximab therapy at a dose of 1000–500 mg twice with an interval of 2 weeks, who received at least one course of therapy with this drug. As RA worsened, patients were switched to olokizumab against the background of standard DMARDs. At 4, 8, 12 weeks after the switch, the severity of pain was assessed on the VAS scale, the number of painful and swollen joints (TJC28 and TSC28), the level of acute phase markers of inflammation, the DAS28 disease activity index calculated using ESR and CRP, and the CDAI (clinical activity index), functional state index HAQ, as well as assessment of the safety profile of therapy.Results. Data analysis was performed using median values (Me) were used for data analysis. A significant decrease of TJC28 was after the injection of olokizumab (Artlegia®) in 8 and 12 weeks (Me baseline = 10; Me 8 weeks = 4; Me 12 weeks = 4; p<0.05) and a decrease of TSC28 in 4, 8 and 12 weeks (Me baseline = 9; Me 4 weeks = 3.5; Me 8 weeks = 2.5; Me 12 weeks = 2.0; p<0.05). Laboratory markers of inflammation showed a decrease in CRP and ESR levels after 4 weeks of treatment (CRP: Me baseline = 21, Me 4 weeks = 1 (p<0.05); ESR: Me baseline = 31, Me 4 weeks = 7 (p<0.05)). Positive dynamics persisted at 8 and 12 weeks (CRP: Me 8 weeks = 1, Me 12 weeks = 0; ESR: Me 8 weeks = 4, Me 12 weeks = 5). The level of CRP by the fourth week 4 became within the normal range, regardless of the initial values. All activity indices improved from the fourth week in each evaluation period compared to baseline: DAS28-ESR: Me baseline = 5.52, Me 4 weeks = 3.59, Me 8 weeks = 3.33, Me 12 weeks = 3.22 (p<0.05); DAS28-CRP: Me baseline = 5.39, Me 4 weeks = 3.71, Me 8 weeks = 3.35, Me 12 weeks = 3.45 (p<0.05); CDAI: Me baseline = 28.5, Me 4 weeks = 18.0, Me 8 weeks = 16.5, Me 12 weeks = 16.0 (p<0.05). All patients showed a reduction in pain (VAS scale) by week 8. The functional status of patients, according to the HAQ index, showed a significant decrease only by the 12th week of the study: Me baseline = 1.62, Me 12 weeks = 1.31 (p<0.05).Conclusion. The study found that switching from rituximab to olokizumab was effective and safe during the COVID-19 pandemic.

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Section: Discussionunclassified

Section: Introductionunclassified

Results of a 12-week open-label, non-interventional study of the efficacy and safety of olokizumab therapy in patients with rheumatoid arthritis after switching from anti-B-cell therapy during the SARS-CoV-2 pandemic

Akimova¹,

Banshchikova²,

Сизиков

et al. 2023

Naučno-praktičeskaâ revmatologiâ

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“…Patients with rheumatic disease on DMARDs like le unomide might have a protective role by prevention of cytokine storm from severe COVID19 [23]. Other studies the WHO pharmacovigilance data suggestive of more frequent presentation of COVID-19 is in ammatory rheumatic disease (IRD) patients on TNF inhibitors [24]. In accordance with our report, during the study period, a nationwide cohort study demonstrated that patients with rheumatic diseases treated with a high dose of corticosteroid associated with adverse outcome of COVID-19, however patients on DMARDs were at lower risk in disease outcome [25].…”

Section: Discussionmentioning

confidence: 99%

Seroprevalence to SARS-CoV-2 in Patients with Rheumatic Diseases on Disease Modifying Antirheumatic Drugs and /or Immunosuppressive Medications from India: A Multicentric Study

Misra¹,

Bhattacharya

Ahmed

et al. 2022

SSRN Journal

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“…In VeroE6 P‐glycoprotein knockout cells, nirmatrelvir has been shown to potently inhibit the replication of SARS‐CoV‐2 viruses, suggesting that nirmatrelvir is a substrate of P‐glycoprotein, 120 although the involvement of P‐glycoprotein has not been fully confirmed 121 . In contrast to molnupiravir and nirmatrelvir, remdesivir has been identified to be a substrate of multiple transporters including BSEP, MATE1, MRP4, NTCP, OATP1B1/1B3, and OCT1 122,123 . These transporters are abundantly expressed in the liver.…”

Section: Metabolism and Active Transportmentioning

confidence: 99%

Viral target and metabolism‐based rationale for combined use of recently authorized small molecule COVID‐19 medicines: Molnupiravir, nirmatrelvir, and remdesivir

Yan

2023

Fundamemntal Clinical Pharma

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The COVID-19 pandemic remains a major health concern worldwide, and SARS-CoV-2 is continuously evolving. There is an urgent need to identify new antiviral drugs and develop novel therapeutic strategies. Combined use of newly authorized COVID-19 medicines including molnupiravir, nirmatrelvir, and remdesivir has been actively pursued. Mechanistically, nirmatrelvir inhibits SARS-CoV-2 replication by targeting the viral main protease (M pro ), a critical enzyme in the processing of the immediately translated coronavirus polyproteins for viral replication. Molnupiravir and remdesivir, on the other hand, inhibit SARS-CoV-2 replication by targeting RNA-dependent RNA-polymerase (RdRp), which is directly responsible for genome replication and production of subgenomic RNAs. Molnupiravir targets RdRp and induces severe viral RNA mutations (genome), commonly referred to as error catastrophe. Remdesivir, in contrast, targets RdRp and causes chain termination and arrests RNA synthesis of the viral genome. In addition, all three medicines undergo extensive metabolism with strong therapeutic significance. Molnupiravir is hydrolytically activated by carboxylesterase-2 (CES2), nirmatrelvir is inactivated by cytochrome P450-based oxidation (e.g., CYP3A4), and remdesivir is hydrolytically activated by CES1 but covalently inhibits CES2. Additionally, remdesivir and nirmatrelvir are oxidized by the same CYP enzymes. The distinct mechanisms of action provide strong rationale for their combined use. On the other hand, these drugs undergo extensive metabolism that determines their therapeutic potential. This review discusses how metabolism pathways and enzymes involved should be carefully considered during their combined use for therapeutic synergy.

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COVID‐19 in DMARD‐treated patients with inflammatory rheumatic diseases: Insights from an analysis of the World Health Organization pharmacovigilance database

Cited by 15 publications

References 58 publications

Results of a 12-week open-label, non-interventional study of the efficacy and safety of olokizumab therapy in patients with rheumatoid arthritis after switching from anti-B-cell therapy during the SARS-CoV-2 pandemic

Results of a 12-week open-label, non-interventional study of the efficacy and safety of olokizumab therapy in patients with rheumatoid arthritis after switching from anti-B-cell therapy during the SARS-CoV-2 pandemic

Seroprevalence to SARS-CoV-2 in Patients with Rheumatic Diseases on Disease Modifying Antirheumatic Drugs and /or Immunosuppressive Medications from India: A Multicentric Study

Viral target and metabolism‐based rationale for combined use of recently authorized small molecule COVID‐19 medicines: Molnupiravir, nirmatrelvir, and remdesivir

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