Clinical Trials

Date: 2018-10-02

Type of information: Results

phase: 2

Announcement: results

Company: Swedish Orphan Biovitrum - SOBI (Sweden)

Product: Kineret® (anakinra)

Action mechanism:

  • protein/interleukin-1 receptor antagonist. Kineret® (anakinra) is a recombinant protein drug that blocks the biological activity of IL-1a and IL -1b by binding to interleukin-1 type 1 receptor (IL-R 1), expressed in a variety of tissues and organs, and thereby blocking the interleukin-1 (IL-1) signalling. IL-1 is a key mediator of inflammation and driver of autoinflammatory diseases in both adults and children.
  • Kineret® is indicated in the US for reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis, in patients 18 years of age or older who have failed 1 or more disease modifying antirheumatic drugs (DMARDs), and for the treatment of neonatal-onset multisystem inflammatory disease (NOMID, a form of cryopyrin-associated periodic syndromes (CAPS)).
  • In Europe, Kineret® is indicated in adults for the treatment of the signs and symptoms of rheumatoid arthritis (RA) in combination with methotrexate, with an inadequate response to methotrexate alone. In addition, Kineret® is indicated in adults, adolescents, children and infants aged 8 months and older with a body weight of 10 kg or above for the treatment of cryopyrin-associated periodic syndromes (CAPS), including - neonatal-onset multisystem inflammatory disease (NOMID)/chronic infantile neurological, cutaneous, articular syndrome (CINCA), Muckle-Wells syndrome (MWS) and familial cold auto inflammatory syndrome (FCAS). It is also indicated in adults, adolescents, children and infants aged 8 months and older with a body weight of 10 kg or above for the treatment of Still’s disease, including Systemic Juvenile Idiopathic Arthritis (SJIA) and Adult-Onset Still’s Disease (AOSD), with active systemic features of moderate to high disease activity, or in patients with continued disease activity after treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or glucocorticoids. Kineret® can be given as monotherapy or in combination with other anti-inflammatory drugs and disease-modifying antirheumatic drugs (DMARDs).

Disease: acute gout

Therapeutic area: Inflammatory diseases

Country: USA

Trial details:

  • The anaGO study is a randomised, double-blind, active-control, multicentre, efficacy and safety study of two dose levels of subcutaneous anakinra for five days compared to a single dose of intramuscular triamcinolone in the treatment of acute gout. The initial phase of the study for the first gout flare is followed by an extension phase where additional flares occurring in the study population are treated until the last randomised patient has been followed for 1 year. The primary objective was to evaluate the efficacy with respect to patient-assessed pain intensity for up to 72 hours after initiation of dosing in the treatment of the first flare. Secondary endpoints included additional measures of efficacy as well as safety and tolerability. The study randomised 165 patients for whom conventional therapy with NSAIDs and colchicine was contraindicated, not tolerated, or did not provide an adequate response. The patients were randomised to anakinra 100 mg/day, anakinra 200 mg/day, or one injection of triamcinolone 40 mg, in equally sized groups. (NCT03002974)

Latest news:

  • • On October 2, 2018,  Swedish Orphan Biovitrum released the primary efficacy results from the phase 2 study with anakinra in patients with acute gout – the anaGO study. For the primary endpoint of patient assessed pain intensity in the most affected joint there was a substantial reduction from baseline, both following treatment with anakinra and the comparator triamcinolone. There was a clinically meaningful pain reduction with anakinra of around 50% and in line with expectations of IL-1 blockade in this disease.
  • No statistically significant difference between the two treatments was obtained (primary endpoint). The well-established safety profile of anakinra was confirmed in the study.
  • Sobi will continue to collect data from the extension phase of the phase 2 study to obtain further data in this patient population where further gout flares will be studied. Sobi plans to meet with the FDA to discuss options for moving anakinra forward into phase 3.
  • • On November 1, 2017, Swedish Orphan Biovitrum announced that the first patient has been randomised in the phase II study (anaGO) to evaluate efficacy and safety of Kineret® (anakinra) in the treatment of acute gout.
  • The purpose of the study is to evaluate pain relief in people with acute gout who cannot take or have not previously responded to non-steroidal anti-inflammatory drugs (NSAIDs) and colchicine. The anaGO study is a randomised, double-blind, multicentre study being conducted in North America studying two dose levels of anakinra (s.c.) in comparison to intramuscular triamcinolone. In total 159 individuals are planned to be randomised in the study.

Is general: Yes