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Articles

Evidence for use of siltuximab or anakinra as second line therapies (after failure of tocilizumab) for Cytokine Release Syndrome following use of Chimeric Antigen Receptor T-cell (CAR-T) therapy

10 May 2019CAR-T therapy often causes cytokine release syndrome (CRS) which is treated with tocilizumab as first-line therapy. Tocilizumab is licensed for this indication but in some…
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Refrigerated Storage

KineretSwedish Orphan Biovitrum

Swedish Orphan Biovitrum
Kineret
100 mg solution for injection in a pre-filled syringe

In the event of an inadvertent temperature excursion the following data may be used:

For the purpose of ambulatory use, Kineret may be removed from the refrigerator for 12 hours at a temperature not above 25 °C. At the end of this period, the product must not be put back in the refrigerator and must be disposed of.

Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

Contact Swedish Orphan Biovitrum Ltd in all cases where a deviation from the recommended storage conditions has occurred. Refer to the current BNF for company contact details.

 

Yes - see above.
No - see above.
19 November 2020
London MI Service

Lactation Safety Information

Recombinant human interleukin-1 receptor antagonist - IL-1Ra

Recombinant human interleukin-1 receptor antagonist - IL-1Ra
See summary
Normal component of breast-milk
Only very limited anecdotal evidence of safety which indicates no effects in a breastfed infant
If clinically indicated monitor infant for signs of neutropenia, which is common in therapeutic use in adults
15 September 2019

New Medicines

Kineret Coronavirus disease 2019 (COVID-19) in hospitalised adults with pneumonia who are at risk of developing severe respiratory failure

Information

Kineret
Licence extension / variation
SOBI (Swedish Orphan Biovitrum)
SOBI (Swedish Orphan Biovitrum)

Development and Regulatory status

None
Pre-registration (Filed)
None
Jun 21Currently pre-registration in the EU [3].

Category

A recombinant non-glycosylated human interleukin-1 receptor antagonist expressed in Escherichia coli
COVID-19 is an infectious disease caused by coronavirus SARS-CoV-2. Most people infected experience mild to moderate respiratory illness and recover without requiring special treatment. Older people, and those with underlying medical problems are more likely to develop serious illness [1].
Coronavirus disease 2019 (COVID-19) in hospitalised adults with pneumonia who are at risk of developing severe respiratory failure
Subcutaneous injection

Trial or other data

Sep 21Positive data from the PIII double-blind, RCT SAVE-MORE trial (n=594 pts with COVID-19 at risk of progressing to respiratory failure) published in Nature Medicine. At day 28, the odds of having a worse clinical status (assessed by the WHO Clinical Progression Scale [WHO-CPS]) with anakinra vs. placevo was 0.36 (95% CI; 0.26 to 0.50). The median WHO-CPS decrease on day 28 from baseline in the placebo and anakinra groups was 3 and 4 points; the respective median decrease of Sequential Organ Failure Assessment (SOFA) score on day 7 from baseline was 0 and 1 points. Mortality at 28 days decreased (hazard ratio = 0.45, P = 0.045), and hospital stay was shorter. [4]
Mar 21PIII SAVE-MORE study is no longer recruiting and has completed collection of primary outcome data [2].
Dec 20Pivotal PIII SAVE-MORE study to to evaluate the efficacy and safety of early start of anakinra guided by suPAR in patients with LRTI by SARS-CoV-2 in improving the clinical state of COVID-19 over 28 days as measured by the ordinal scale of the 11-point World Health Organization (WHO) clinical progression scale (CPS) starts (NCT04680949). 606 adults will be recruited in Italy and Greece. Primary outcome is comparison of the distribution of frequencies of each score of a 5-scale patient state evaluated from the 11-point WHO Clinical Progression ordinal Scale (CPS) between the two arms of treatment; collection of these data is due to complete Mar 21 [2].

KineretFamilial Mediterranean fever (FMF)

Information

Kineret
Licence extension / variation
SOBI (Swedish Orphan Biovitrum)
SOBI (Swedish Orphan Biovitrum)

Development and Regulatory status

Launched
Launched
None
May 2020
May 20Approved in the EU [3].
Mar 20CHMP positive opinion recommending approval of a new indication for the treatment of FMF in adults, adolescents, children and infants aged 8 months and older with a body weight of 10 kg or above [2].

Category

A recombinant non-glycosylated human interleukin-1 receptor antagonist expressed in Escherichia coli
Familial Mediterranean fever mainly affects specific racial groups originating from around the eastern Mediterranean Sea. These include Arabs, Armenians, Italians (mild form), Jews and Turks. In these groups, 1 in 25 to 1 in 2000 people are affected. By comparison, in west Europeans, the prevalence is 2.5 per 100,000 (1 in 40,000) people [1].
Familial Mediterranean fever (FMF)
Intravenous