Serum profile of transferrin isoforms in rheumatoid arthritis treated with biological drugs

Background:The presence of central sensitization (CS) significantly burdens the course of rheumatoid arthritis (RA). JAK inhibitors block intracellular signal pathways including the ones responsible for synthesis of mediators and cytokines causing pain and CS. The application of JAK inhibitors is supposed to relieve pain and reduce CS severity promptly.Objectives:To evaluate JAK inhibitor effect on pain and signs of CS in patients with active RA 7 and 28 days after the start of therapy.Methods:Study group included 39 patients with RA, their age was 50.9±11.1, 79.5% of women, 89.7% of RF “+”, DAS28 5.8±0.6, receiving DMARDs (methotrexate 82.0% and leflunomide 18.0%), who were administered with tofacitinib 5 mg 2 times a day due to inefficiency or intolerance of genetically engineered biological drugs. There were assessed the pain severity using Brief pain inventory (BPI) questionnaire, the presence of neuropathic pain component (NPC) using PainDETECT questionnaire and signs of CS using Central Sensitisation Inventory (CSI) questionnaire at early time after tofacitinib administration.Results:Patients initially experienced a severe pain – 5.72±2.21 according to the visual analogue scale (VAS), 53.8% had signs of central sensitization (CSI ≥ 40), 17.9% had NPC (PainDETECT ≥18). 7 days after tofacitinib intake there was statistically reliable reduction of pain severity – up to 4.37±2.2 (р=0.01), pain decrease of 29.4±17.9% (BPI), NCP – PainDETECT from 12.9±5.5 to 10.6±5.6 (р=0.047) and CS – CSI from 43.1±12.8 to 35.9±11.2 (р=0.01). The effect had increased after 28 days: pain level (VAS) was 2.84±1.57 (р=0.000), pain decrease of 43.6±29.6% (BPI), PainDETECT 29.8±12.4 (р=0.000), CSI 26.4±13.9 (р=0.000).During this period there were no serious adverse reactions.Conclusion:The application of JAK inhibitor tofacitinib allows to reach a fast analgesic effect, also due to impact on CS and NCP.Source: National Registry patients with RADisclosure of Interests: :Andrey Karateev: None declared, Ekaterina Filatova: None declared, Elena Pogozheva: None declared, Vera Amirdzhanova: None declared, Evgeny Nasonov: None declared, Alexander Lila: None declared, V Mazurov: None declared, N Lapkina: None declared, Galina Lukina Speakers bureau: Novartis, Pfizer, UCB, Abbvie, Biocad, MSD, Roche, Tatiana Salnikova: None declared, Ruzana Samigullina: None declared, Diana Chakieva: None declared, Irina Marusenko: None declared, Olga Semagina: None declared, Marina Semchenkova: None declared

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Systemic Inflammatory Parameters in Patients with Elderly-Onset Rheumatoid Arthritis (EORA) and Young-Onset Rheumatoid Arthritis (YORA)—An Observational Study

Journal of Clinical Medicine ◽

10.3390/jcm10061204 ◽

2021 ◽

Vol 10 (6) ◽

pp. 1204

Author(s):

Bożena Targońska-Stępniak ◽

Krzysztof Grzechnik ◽

Katarzyna Kolarz ◽

Danuta Gągoł ◽

Maria Majdan

Keyword(s):

Rheumatoid Arthritis ◽

Disease Activity ◽

Biological Drugs ◽

Young Onset ◽

Inflammatory Parameters ◽

Cell Counts ◽

Frequent Use ◽

Hematological Markers ◽

Specific Subset ◽

Elderly Onset

Background: Rheumatoid arthritis (RA) occurs more often in elderly individuals. Elderly onset RA (EORA) (onset > 60 years) encompasses a specific subset of patients if compared with young onset RA (YORA) (onset at a younger age). There is a need to define reliable, simple markers to properly assess the inflammatory activity of RA. Hematological markers of systemic inflammation (Platelet-To-Lymphocyte (PLR) and Neutrophil-To-Lymphocyte (NLR) ratios) are novel measures of the inflammatory response. The goal of the study was to analyze the course of EORA vs. YORA patients and to assess associations between systemic and clinical disease activity markers, including PLR and NLR, in different subsets of patients. PLR and NLR have not previously been assessed in EORA and YORA. Methods: The study group consisted of 113 consecutive patients (63 EORA and 50 YORA). The following assessments were performed: joint counts, Disease Activity Score (DAS28), complete blood cell counts, erythrocyte sedimentation rate (ESR), and C-reactive protein (CRP). Results: EORA was characterized by significantly higher disease activity markers (conventional inflammatory and clinical), a lower rate of remission or low disease activity, and less frequent use of biological drugs and glucocorticoids. The NLR and PLR were positively correlated with disease activity markers. The PLR was significantly lower in EORA compared with in YORA. Conclusion: EORA and YORA patients differed significantly. In EORA, conventional disease activity markers were higher, the PLR was significantly lower.

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Effects of Conventional and Biological Drugs Used for the Treatment of Rheumatoid Arthritis on the Quality of Life and Depression

Eurasian Journal of Medicine ◽

10.5152/eurasianjmed.2018.18018 ◽

2019 ◽

Vol 51 (1) ◽

pp. 12-16 ◽

Cited By ~ 4

Author(s):

Yakup Ilker Yayikci ◽

◽

Ahmet Karadag ◽

Keyword(s):

Quality Of Life ◽

Rheumatoid Arthritis ◽

Biological Drugs

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RHEUMATOID ARTHRITIS IN ELDERLY PEOPLE

Wiadomości Lekarskie ◽

10.36740/wlek201909113 ◽

2019 ◽

Vol 72 (9) ◽

pp. 1676-1682

Author(s):

Bożena Targońska-Stępniak

Keyword(s):

Rheumatoid Arthritis ◽

Sudden Onset ◽

Careful Monitoring ◽

Internal Organs ◽

Biological Drugs ◽

Inflammatory Parameters ◽

Shoulder Joints ◽

Elderly Onset ◽

Age Over 60 ◽

Citrullinated Peptide

Rheumatoid arthritis (RA) is a chronic, systemic connective tissue disease, characterized by progressive, destructive polyarthritis with internal organs involvement due to active, systemic inflammation. The onset of disease occurs usually in 4th or 5th decade of life. Since the general population is ageing, beginning of RA in older age is more and more common. The term elderly onset of rheumatoid arthritis (EORA) describes the disease with onset at age over 60. Several observational studies indicated, that proportion of women and men is comparable in EORA. Clinical course of the disease is characterized by sudden onset with general constitutional symptoms, high disease activity and inflammatory parameters. Involvement of large joints is more common, specially shoulder joints. Antibodies typical for RA (rheumatoid factor, anti-citrullinated peptide) are usually negative. More advanced destructive changes of joints and functional impairment are also characteristic for EORA patients in comparison with younger onset of RA (YORA). In clinical practice the use of methotrexate and biological drugs is less common, and glucocorticosteroids more common in EORA. Due to high RA activity, patients with EORA should be treated in the same way as YORA, with careful monitoring due to higher risk of adverse events associated with treatment.

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Cost-effectiveness analysis of treatment sequences containing tofacitinib for the treatment of rheumatoid arthritis in Spain

Clinical Rheumatology ◽

10.1007/s10067-020-05087-3 ◽

2020 ◽

Vol 39 (10) ◽

pp. 2919-2930 ◽

Cited By ~ 2

Author(s):

F. Navarro ◽

J. M. Martinez-Sesmero ◽

A. Balsa ◽

C. Peral ◽

M. Montoro ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Cost Effectiveness ◽

Cost Saving ◽

Inadequate Response ◽

Concomitant Treatment ◽

Biological Therapies ◽

Biological Drugs ◽

Line Therapy ◽

Treatment Sequences

Abstract Objective To assess the cost-effectiveness of tofacitinib-containing treatment sequences versus sequences containing only standard biological therapies in patients with moderate-to-severe rheumatoid arthritis (RA) after the failure of conventional synthetic disease-modifying antirheumatic drugs (csDMARD-IR population) and in patients previously treated with methotrexate (MTX) who show an inadequate response to second-line therapy with any tumour necrosis factor inhibitor (TNFi-IR population). Methods A patient-level microsimulation model estimated, from the perspective of the Spanish Public NHS, lifetime costs and quality-adjusted life years (QALY) for treatment sequences starting with tofacitinib (5 mg twice daily) followed by biological therapies versus sequences of biological treatments only. Concomitant treatment with MTX was considered. Model’s parameters comprised demographic and clinical inputs (initial Health Assessment Questionnaire [HAQ] score and clinical response to short- and long-term treatment). Efficacy was measured by means of HAQ score changes using mixed treatment comparisons and data from long-term extension (LTE) trials. Serious adverse events (SAEs) data were derived from the literature. Total cost estimation (€, 2018) included drug acquisition, parenteral administration, disease progression and SAE management. Results In the csDMARD-IR population, sequences starting with tofacitinib proved dominant options (more QALYs and lower costs) versus the corresponding sequences without tofacitinib. In the TNFi-IR population, first-line treatment with tofacitinib+MTX followed by scAbatacept+MTX➔rituximab+MTX➔certolizumab+MTX proved dominant versus scTocilizumab+MTX➔scAbatacept+MTX➔rituximab+MTX➔certolizumab+MTX; and tofacitinib+MTX➔scTocilizumab+MTX➔scAbatacept+MTX➔rituximab+MTX versus scTocilizumab+MTX➔scAbatacept+MTX➔rituximab+MTX➔certolizumab+MTX was less effective but remained a cost-saving option. Conclusions Inclusion of tofacitinib seems a dominant strategy in moderate-to-severe RA patients after csDMARDs failure. Tofacitinib, as initial third-line therapy, proved a cost-saving strategy (€− 337,489/QALY foregone) in moderate-to-severe TNFi-IR RA patients. Key points• Therapeutical approach in rheumatoid arthritis (RA) consisted in sequences of several therapies during patient lifetime.• Treatment sequences initiating with tofacitinib followed by biological drugs provided higher health effects in csDMARDs-IR population, compared with sequences containing only biological drugs.• In both csDMARD-IR and TNFi-IR RA populations, initiating treatment with tofacitinib was associated to lower treatment costs for the Spanish National Health System.

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Pharmacoeconomic evaluation of rheumatoid arthritis treatment with selected biological drugs

Reumatologia/Rheumatology ◽

10.5114/reum.2012.32430 ◽

2012 ◽

Vol 6 ◽

pp. 472-477

Author(s):

Krzysztof Kowalik ◽

Jerzy Krysiński ◽

Urszula Białecka ◽

Katarzyna Kolossa ◽

Sławomir Jeka

Keyword(s):

Rheumatoid Arthritis ◽

Pharmacoeconomic Evaluation ◽

Biological Drugs ◽

Rheumatoid Arthritis Treatment

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Rheumatoid arthritis: biological drugs and risk of infection

The Lancet ◽

10.1016/s0140-6736(14)61907-3 ◽

2015 ◽

Vol 386 (9990) ◽

pp. 224-225 ◽

Cited By ~ 7

Author(s):

William G Dixon

Keyword(s):

Rheumatoid Arthritis ◽

Risk Of Infection ◽

Biological Drugs

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Pharmacovigilance of Biopharmaceuticals in Rheumatic Diseases, Adverse Events, Evolution, and Perspective: An Overview

Biomedicines ◽

10.3390/biomedicines8090303 ◽

2020 ◽

Vol 8 (9) ◽

pp. 303

Author(s):

Sandra Rodríguez ◽

Andrés Muñoz ◽

Rosa-Helena Bustos ◽

Diego Jaimes

Keyword(s):

Rheumatoid Arthritis ◽

Systemic Lupus Erythematosus ◽

Adverse Events ◽

Rheumatic Diseases ◽

Lupus Erythematosus ◽

Cell Mediated Immunity ◽

Systemic Lupus ◽

Biological Drugs ◽

Necrosis Factor Alpha ◽

Post Marketing

Since we have gained an understanding of the immunological pathophysiology of rheumatic diseases such as rheumatoid arthritis and systemic lupus erythematosus, treatment based on biological drugs has become a fundamental axis. These therapies are oriented towards the regulation of cytokines such as tumour necrosis factor-alpha (TNF-α), interleukin (IL)-6, IL-1, and the modulation of cell-mediated immunity (B cells and T cells) by anti CD20 or anti CTAL-4 agents, and can increase the risk of associated infections or adverse events (AE). In this context, the entry of biotherapeutics represented a challenge for pharmacovigilance, risk management and approval by the main global regulatory agencies regarding biosimilars, where efficacy and safety are based on comparability exercises without being an exact copy in terms of molecular structure. The objective of this review is divided into three fundamental aspects: (i) to illustrate the evolution and focus of pharmacovigilance at the biopharmaceutical level, (ii) to describe the different approved recommendations of biopharmaceuticals (biological and biosimilars) and their use in rheumatic diseases (RDs) such as rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), systemic lupus erythematosus (SLE) and other less frequent RD like cryopyrin-associated autoinflammatory syndromes (CAPS), and (iii) to identify the main AE reported in the post-marketing phase of RD biopharmaceuticals.

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