Adjunctive anakinra in patients with active rheumatoid arthritis despite methotrexate, or leflunomide, or cyclosporin-A monotherapy: a 48-week, comparative, prospective study

Karanikolas, George; Charalambopoulos, D.; Vaiopoulos, George; Andrianakos, A.; Rapti, Ageliki; Karras, D.; Kaskani, E; Sfikakis, Petros P.

doi:10.1093/rheumatology/ken223

Cited by 21 publications

(17 citation statements)

References 24 publications

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“…Severe infections were extremely rare [20,22]. The results obtained in observational studies confirm the conclusions drawn from randomized trials.…”

Section: Resultssupporting

confidence: 78%

“…The results of observational studies confirm the effectiveness of treatment with anakinra in combination with MTX or other DMARDs in accordance with ACR20 [19,20], EULAR [21], and DAS28 criteria [20,21]. In addition, it was confirmed that anakinra combined with MTX improves patients' functional status assessed using the HAQ questionnaire [21], as well as reducing the number of swollen joints and painful joints, the severity of pain and serum C-reactive protein concentration [20].…”

Section: Resultsmentioning

confidence: 57%

“…In addition, it was confirmed that anakinra combined with MTX improves patients' functional status assessed using the HAQ questionnaire [21], as well as reducing the number of swollen joints and painful joints, the severity of pain and serum C-reactive protein concentration [20].…”

Section: Resultsmentioning

confidence: 96%

“…The analysis of the safety of anakinra revealed that the most common adverse events following its administration were: allergic reactions at the injection site [20][21][22], joint pain [22], a worsening of the symptoms of RA [22], and infections [21,22]. Severe infections were extremely rare [20,22].…”

Section: Resultsmentioning

confidence: 99%

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Anakinra in the treatment of rheumatoid arthritis in adult patients with an inadequate response to methotrexate. Systematic review and meta-analysis

Kawalec¹,

Holko²,

Paszulewicz³

2013

Reumatologia

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S u m m a r y B Ba ac ck kg gr ro ou un nd d: : Anakinra is an interleukin-1 receptor antagonist (IL-1Ra) that blocks the biological activity of IL-1, including inflammation. Anakinra in combination with methotrexate (MTX) is indicated for reduction in signs and symptoms in active rheumatoid arthritis, in adults who have failed one or more disease-modifying antirheumatic drugs (DMARDs). M Ma at te er ri ia al l a an nd d m me et th ho od ds s: : According to the rules of evidence-based medicine popularized by The Cochrane Collaboration, a systematic review of medical literature has been performed in order to assess clinical efficacy and safety of the therapy. The review yielded three randomized clinical studies which compared the administration of anakinra in combination with MTX (or other DMARDs) to placebo with MTX. R Re es su ul lt ts s: : Moderate clinical efficacy defined as ACR20, ACR50 and ACR70 response and safety profile of anakinra in combination with MTX or other DMARDs was proven in most studies mentioned and confirmed by the results of the meta-analysis performed. C Co on nc cl lu us si io on ns s: : Injection site reactions were the most common adverse events frequently leading to withdrawal. S t r e s z c z e n i eW Ws st tę ęp p: : Anakinra jest rekombinowanym ludzkim antagonistą receptora interleukiny 1 (IL-1Ra), który prowadzi do zahamowania aktywności biologicznej IL-1, m.in. działania prozapalnego. Anakinra w skojarzeniu z metotreksatem (MTX) jest zalecana w leczeniu przedmiotowych i podmiotowych objawów reumatoidalnego zapalenia stawów (RZS) u dorosłych pacjentów, u których zastosowanie jednego lub więcej leków modyfikujących przebieg choroby (LMPCh) nie przyniosło pożądanych efektów. M Ma at te er ri ia ał ł i i m me et to od dy y: : W celu oceny skuteczności klinicznej tej opcji terapeutycznej, zgodnie z zasadami medycyny opartej na dowodach naukowych (evidence based medicine -EBM) zalecanymi przez organizację The Cochrane Collaboration oraz polską Agencję Oceny Technologii Medycznych (AOTM), dokonano systematycznego przeglądu literatury medycznej, w wyniku którego odnaleziono łącznie trzy badania kliniczne z randomizacją dotyczące porównania anakinry stosowanej z MTX (lub innymi LMPCh) względem placebo podawanego z MTX. W Wy yn ni ik ki i: : Umiarkowana skuteczność kliniczna wg kryteriów ACR20, ACR50, ACR70 i bezpieczeństwo stosowania anakinry w terapii skojarzonej u pacjentów z RZS została potwierdzona w większości odnalezionych badań oraz dodatkowo na podstawie wyników metaanaliz przeprowadzonych z wykorzystaniem wyników przeglądu systematycznego. W Wn ni io os sk ki i: : Najczęstszym występującym działaniem niepożądanym, któ-re w wielu przypadkach było przyczyną rezygnacji z dalszego leczenia, było pojawienie się reakcji alergicznej w miejscu wstrzyknięcia leku.A Ad dr re es ss s f fo or r c co or rr re es sp po on nd de en nc ce e: : dr n. med. Paweł Kawalec, Zakład Gospodarki Lekiem, Instytut Zdrowia Publicznego, Wydział Nauk o Zdrowiu, Uniwersytet Jagielloński, ul. Grzegórzecka 20, ...

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“…Severe infections were extremely rare [20,22]. The results obtained in observational studies confirm the conclusions drawn from randomized trials.…”

Section: Resultssupporting

confidence: 78%

Section: Resultsmentioning

confidence: 57%

Section: Resultsmentioning

confidence: 96%

Section: Resultsmentioning

confidence: 99%

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Anakinra in the treatment of rheumatoid arthritis in adult patients with an inadequate response to methotrexate. Systematic review and meta-analysis

Kawalec¹,

Holko²,

Paszulewicz³

2013

Reumatologia

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“…At 48 weeks, the percentage of patients achieving ACR20, ACR50, and ACR70 responses were 73%, 41%, and 23% respectively. 41 Another pooled analysis of 5 clinical trials involving 2846 patients reported significant improvement of ACR20 response in the participants treated with anakinra 50 to 150 mg daily vs placebo after 24 weeks (38% vs 23%). Significant improvements were also observed with anakinra vs placebo in the following parameters: ACR50 (18% vs 7%), ACR70 (7% vs 2%), HAQ score, visual analogue score for pain, Larsen radiographic scores, and ESR.…”

Section: Interleukin-1 Receptor Blockermentioning

confidence: 99%

Biological targets in the treatment of rheumatoid arthritis: a comprehensive review of current and in-development biological disease modifying anti-rheumatic drugs

Efthimiou¹,

Petryna²,

Kukar³

2009

BTT

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Injection-site reactions upon Kineret (anakinra) administration: experiences and explanations

et al. 2011

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Anakinra (Kineret), a recombinant form of human interleukin-1 (IL-1) receptor antagonist, is approved for the treatment of rheumatoid arthritis (RA) in combination with methotrexate. Kineret is self-administered by daily subcutaneous injections in patients with active RA. The mechanism of action of anakinra is to competitively inhibit the local inflammatory effects of IL-1. Kineret is generally safe and well tolerated and the only major treatment-related side effects that appear are skin reactions at the injection site. Due to the relatively short half-life of anakinra, daily injection of the drug is required. This, in combination with the comparably high rates of injection-site reactions (ISRs) associated with the drug, can become a problem for the patient. The present review summarises published data concerning ISRs associated with Kineret and provides some explanations as to their cause. The objective is also to present some clinical experiences of how the ISRs can be managed.

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Adjunctive anakinra in patients with active rheumatoid arthritis despite methotrexate, or leflunomide, or cyclosporin-A monotherapy: a 48-week, comparative, prospective study

Abstract: Considering the limitations of an open-label study, addition of ANK appears to be an effective and well-tolerated treatment option for many RA patients with inadequate responses to non-biologic DMARDs in clinical practice.

Cited by 21 publications

References 24 publications

Anakinra in the treatment of rheumatoid arthritis in adult patients with an inadequate response to methotrexate. Systematic review and meta-analysis

Anakinra in the treatment of rheumatoid arthritis in adult patients with an inadequate response to methotrexate. Systematic review and meta-analysis

Biological targets in the treatment of rheumatoid arthritis: a comprehensive review of current and in-development biological disease modifying anti-rheumatic drugs

Injection-site reactions upon Kineret (anakinra) administration: experiences and explanations

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