The effect of olokizumab on rheumatoid arthritis patient’s reported outcomes: results of a double-blind randomized placebo-controlled multicenter phase III trial (CREDO 1)

Nasonov, E.; Лисицына, Т. А.; Зонова, Е. В.; Кузькина, С. М.

doi:10.47360/1995-4484-2021-62-69

Naučno-praktičeskaâ revmatologiâ

2021

DOI: 10.47360/1995-4484-2021-62-69

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The effect of olokizumab on rheumatoid arthritis patient’s reported outcomes: results of a double-blind randomized placebo-controlled multicenter phase III trial (CREDO 1)

E. Nasonov

Т. А. Лисицына²,

Е. В. Зонова

et al.

Abstract: О р и г и н а л ь н ы е и с с л е д о в а н и я

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Cited by 6 publications

References 40 publications

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Olokizumab effect on chronic pain in rheumatoid arthritis: Results of the PROLOGUE observational study

Karateev,

Polishchuk,

Filatova

et al. 2024

Int J of Rheum Dis

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AimEvaluate the efficacy and safety ® (olokizumab) in patients with rheumatoid arthritis (RA) in real‐world clinical practice, with a targeted assessment of patient report outcomes (PRO) and central sensitization.MethodsAn open‐label observational non‐interventional study was conducted, enrolling 183 patients with moderate and severe RA activity. All patients received OKZ 64 mg SC as injections every 4 weeks (Q4W) with methotrexate. The patients' follow‐up period was 24 weeks or less. RA activity (DAS28‐CRP), pain severity (NRS), patient global assessment (PGA, NRS), functional impairment (NRS), fatigue (FACIT‐F), central sensitization (central sensitization inventory, CSI), and symptoms of neuropathic pain (PainDETECT) were evaluated.ResultsThe study cohort was comprised of 144 patients. And 39 patients were lost to follow‐up, refused OKZ treatment, or were not dosed with OKZ for administrative reasons. In 6 months, DAS28‐CRP decreased to 3.3 ± 0.9 (p < .001) and statistically significant reductions in pain intensity, PGA, functional impairment, and fatigue were achieved. Pain intensity decreased as early as 2 days after the first OKZ administration (p < .05). The number of patients with CSI >40 in 24 weeks decreased from 71.0% to 21.0% (p < .001), with PainDETECT >18 – from 21.5% to 13.2%. NSAIDs use decreased from 70.8% to 33.8% (р < .001), steroids – from 54.2% to 32.6%. AEs were reported in 14.2% patients, serious events were observed in three patients.ConclusionOKZ is effective in reducing RA activity and controlling chronic pain related to dysfunction of the nociceptive system.

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Olokizumab effect on chronic pain in rheumatoid arthritis: Results of the PROLOGUE observational study

Karateev,

Polishchuk,

Filatova

et al. 2024

Int J of Rheum Dis

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Comparison of the efficacy and safety of the original rituximab and its biosimilar in routine clinical practice

Kusevich¹,

Olyunin²,

Насонов

2022

Sovremennaâ revmatologiâ

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Currently, a biosimilar (BS) of rituximab (RTM) Acellbia® is widely used in Russia for the treatment of rheumatoid arthritis (RA), however, a systematic study of this drug in routine clinical practice has not been conducted.Objective: to compare the results of the use of RTM BS (Acellbia®) and the original rituximab (oRTM) in the daily clinical practice of a large rheumatology center.Patients and methods. The study involved 127 patients predominantly with seropositive RA, who were divided into four groups. Groups 1 and 2 included 66 bionaive patients with active RA and ineffectiveness of previous therapy. 31 patients of the 1st group received 2 infusions of oRTM at a dose of 500 mg intravenously (IV) 2 weeks apart; 35 patients of the 2nd group – 2 infusions of RTM BS at a dose of 500 mg IV 2 weeks apart. Groups 3 and 4 included 61 patients who had previously received oRTM therapy. These patients received 4 courses of oRTM treatment on average before being included in the study. 30 patients of the 3rd group continued oRTM therapy: they received 2 infusions at a dose of 500 mg IV 2 weeks apart; 31 patients of the 4th group received 2 infusions of RTM BS at a dose of 500 mg IV 2 weeks apart.Results and discussion. During the observation period, the dynamics of the main indicators of RA activity in the 1st and 2nd groups did not differ significantly. Although the indication for rehospitalization was an exacerbation of the disease, 64.5% of patients in the 1st and 77.1% of patients in the 2nd group, preserved a 20% improvement according to the ACR criteria on re-examination. The condition of patients of the 3rd and 4th groups remained generally stable during the observation period. The change in the DAS28 index in most cases was clinically insignificant. There were no significant differences in the dynamics of inflammatory activity among patients who continued oRTM treatment and who received RTM BS.Conclusion. The results of the study show that both the prescription of RTM to bionaive RA patients and repeated courses of treatment with RTM BS and oRTM are comparable in terms of efficacy and tolerability.

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Dynamics of patient reported outcomes during the use various biological disease-modifying antirheumatic drugs for rheumatoid arthritis

Karateev¹,

Лила

Panevin³

et al. 2022

Naučno-praktičeskaâ revmatologiâ

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One of the main tasks of modern complex therapy of rheumatoid arthritis (RA) is to improve the quality of life of patients. To do this, it is necessary not only to achieve remission or low activity, but also to successfully control the main, most painful, manifestations of the disease. Therefore, when evaluating the results of RA treatment, the dynamics of not only standard indices (DAS28 (Disease Activity Score 28), CDAI (Clinical Disease Activity Index), SDAI (Simplified Disease Activity Index)), but also the so-called “patient reported outcomes” (PRO) – a patient’s global assessment of disease activity (PGA), pain, functional disorders and fatigue.This review examines the effect of one of the main classes of anti–rheumatic drugs - biological disease-modifying antirheumatic drugs (bDMARDs) on the PROs. The results of a series of randomized controlled trials are presented, in which changes in PROs were studied using various tumor necrosis factor α (TNF-α) inhibitors, abatacept T-lymphocyte co-stimulation inhibitor, rituximab CD20 inhibitor and interleukin (IL) 6 inhibitors.The use of bDMARDs in combination with methotrexate (MTX) provides a reduction in PGA and pain by 50-60%, functional disorders according to HAQ (Health Assessment Questionnaire) and fatigue according to FACIT-F (Functional Assessment of Chronic Illness Therapy – Fatigue) – by 15-30%. B DMARDs monotherapy (with the exception of the effect of tocilizumab on HAQ) does not exceed MTX monotherapy in its effect on PROs. Monotherapy with tocilizumab provides more favorable dynamics of PGA and pain than monotherapy with TNF-α inhibitors. An important advantage of IL-6 inhibitors is the rapid achievement of a clinical effect, which is noted already in the first 2 weeks after the first administration of the drug.

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The effect of olokizumab on rheumatoid arthritis patient’s reported outcomes: results of a double-blind randomized placebo-controlled multicenter phase III trial (CREDO 1)

Abstract: О р и г и н а л ь н ы е и с с л е д о в а н и я

Cited by 6 publications

References 40 publications

Olokizumab effect on chronic pain in rheumatoid arthritis: Results of the PROLOGUE observational study

Olokizumab effect on chronic pain in rheumatoid arthritis: Results of the PROLOGUE observational study

Comparison of the efficacy and safety of the original rituximab and its biosimilar in routine clinical practice

Dynamics of patient reported outcomes during the use various biological disease-modifying antirheumatic drugs for rheumatoid arthritis

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