ilaris traps patient portal

What is the recommended dose of Ilaris for traps patients?

Learn more about ILARIS® (canakinumab), a biologic that may help with SJIA, CAPS, FMF, HIDS/MKD, & TRAPS. See full Prescribing & Safety Info. For Patients and Caregivers. For Healthcare Professionals; For US Residents Only. For Non-US Residents; Full Prescribing Information; Patient Medication Guide; For Patients and Caregivers. For Healthcare ...

What are the indications of Ilaris?

ILARIS® (canakinumab) ILARIS is the first and only selective IL-1β inhibitor for the treatment of FMF, HIDS/MKD, TRAPS and CAPS in adults, adolescents and children aged ≥2 years. 1 FIND OUT MORE ABOUT ILARIS EFFICACY ILARIS can help FMF, HIDS/MKD and TRAPS patients to achieve a rapid and complete response

Can I give Ilaris to myself?

Active Systemic Juvenile Idiopathic Arthritis (SJIA) in patients aged 2 years. and older. Ilaris, also known as canakinumab, is a biologic injection therapy that treats auto-inflammatory Periodic Fever Syndromes and is the only FDA-approved treatment for Adult-Onset Still’s Disease (AOSD). The dosing regimen for Ilaris is based on the patient ...

Is Ilaris still an orphan medicine?

ILARIS can help FMF, HIDS/MKD and TRAPS patients to achieve a rapid and complete response1 At Week 16, significantly more patients receiving ILARIS had achieved the primary endpoint of a complete response* vs placebo. 1 Adapted from De Benedetti et al. 2018. 1

How do you administer ILARIS?

How long does it take ILARIS to work?

Is ILARIS an immunosuppressant?

Is ILARIS a biologic?

Does Ilaris cause weight gain?

How much does Ilaris cost?

What kind of drug is ILARIS?

What does ILARIS treat?

How often is ILARIS given?

What does biologic mean in medicine?

Who makes Canakinumab?

What age is Ilaris indicated?

ILARIS is indicated for the treatment of the following autoinflammatory periodic fever syndromes in adults, adolescents and children aged 2 years and older 1:

What is the ILARIS inhibitor?

ILARIS is the first and only selective IL-1β inhibitor for the treatment of FMF, HIDS/MKD, TRAPS and CAPS in adults, adolescents and children aged ≥2 years1

How many caps patients were treated with IlaRIS 3?

In a 2-year, open-label study of 166 CAPS patients treated with ILARIS 3:

What is IlaRIS for?

ILARIS can help FMF, HIDS/MKD and TRAPS patients to achieve a rapid and complete response1

How long is the IlaRIS treatment period?

An open-label treatment period in which a single dose of ILARIS was administered. Response was assessed during the following 8 weeks.

What is the primary outcome measure of ILARIS?

The primary outcome measure was the proportion of patients with a relapse of CAPS during treatment with ILARIS, as compared with placebo, in part 2. Secondary outcome measures included the proportion of patients with a complete response in part 1, values of inflammatory markers, global assessments by physicians and patients, and safety and tolerability.

What is the primary endpoint of IlaRIS?

The primary endpoint was the proportion of patients with a relapse of CAPS during treatment with ILARIS, as compared with placebo, in the withdrawal phase . Remission describes patients who did not have a flare in this phase. 2§

Is IlaRIS a placebo controlled trial?

A randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of ILARIS in patients with crFMF (n=63), HIDS/MKD (n=72) and TRAPS (n=46). The trial consisted of one cohort per disease. Each cohort followed the same study design:

What is Ilaris used for?

Ilaris is a medicine for treating the following inflammatory conditions: 4 types of periodic fever syndromes (diseases marked by recurring inflammation and fever) in adults and children aged 2 and above: cryopyrin-associated periodic syndromes (CAPS); tumour necrosis factor receptor associated periodic syndrome (TRAPS);

How effective is Ilaris?

Three studies involving 220 adults and children 2 years and older showed that Illaris was effective at reducing relapses of CAPS symptoms after a 24-week treatment period. In one of the studies, none of the patients with CAPS who received Ilaris during the 24-week treatment period had a relapse, compared with 81% of patients who received placebo (a dummy treatment). In the two other CAPS studies, which did not compare Ilaris with any other treatment, 85% of patients on Ilaris had no relapses at all. The proportion of patients with no relapse was lower (around 57%) for children aged 2 to 4 years.

How often is Ilaris given?

How is Ilaris used? Ilaris is given as a single injection under the skin every 8 weeks for CAPs and every 4 weeks for the other periodic fever syndromes (TRAPS, HIDS/MKD and FMF) and Still’s disease. In patients with gouty arthritis, a single injection is given on-demand to treat gouty arthritis attacks.

Why was Ilaris approved?

Ilaris was originally authorised under ‘ exceptional circumstances ’, because, for scientific reasons, limited information was available at the time of approval. As the company had supplied the additional information requested, the ‘ exceptional circumstances ’ ended on 22 March 2017.

What is the active substance in Ilaris?

By attaching to interleukin‑1 beta, canakinumab blocks its activity, helping to reduce inflammation thereby relieving the symptoms of the diseases.

What is the FMF in Ilaris?

familial mediterranean fever (FMF); Still’s disease, a rare disease causing inflammation of joints as well as rash and fever (in adults and children aged 2 and above); Gouty arthritis, painful inflammation of the joints caused by deposit of urate crystals (in adults). Ilaris contains the active substance canakinumab.

When did Ilaris get a marketing authorisation?

The European Commission granted a marketing authorisation valid throughout the European Union for Ilaris on 23 October 2009. For more information about treatment with Ilaris, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. List item.

How long is Ilaris treatment?

A phase III trial (TRAPS, HIDS/MKD, and FMF Study 1) investigated the safety of Ilaris in 3 cohorts (TRAPS, HIDS/MKD, and FMF) as follows: a 12-week screening period (Part 1), followed by a 16-week, randomized, double-blind, placebo-controlled parallel-arm treatment period (Part 2), followed by a 24-week randomized withdrawal period (Part 3), followed by a 72-week, open-label treatment period (Part 4). All patients randomized to treatment with Ilaris in Part 2 received 150 mg subcutaneously every 4 weeks if body weight was greater than 40 kg (or 2 mg/kg every 4 weeks if body weight was less than or equal to 40 kg).

How long after birth can you give Ilaris?

Because IL-1 blockade may interfere with immune response to infections, risks and benefits should be considered prior to administering live vaccines to infants who were exposed to Ilaris in utero for at least 4 to 12 months following the mother’s last dose of Ilaris. The ideal time to avoid live vaccines in infants exposed to Ilaris in utero is unknown, as there are insufficient data regarding infant serum levels of canakinumab at birth and the duration of persistence of canakinumab in infant serum after birth is also unknown.

How much canakinumab is needed for a SJIA?

Canakinumab volume of distribution (Vss) varied according to body weight and was estimated to be 6.01 liters in a typical CAPS patient weighing 70 kg, 3.2 liters in a SJIA patient weighing 33 kg, and 6.34 liters for a Periodic Fever Syndrome (TRAPS, HIDS/MKD, FMF) patient weighing 70 kg. The expected accumulation ratio was 1.3-fold for CAPS patients and 1.6-fold for SJIA patients following 6 months of subcutaneous dosing of 150 mg Ilaris every 8 weeks and 4 mg/kg every 4 weeks, respectively.

What is the anti-IL-1 antibody?

Canakinumab is a human monoclonal anti-human IL-1β antibody of the IgG1/κ isotype. Canakinumab binds to human IL-1β and neutralizes its activity by blocking its interaction with IL-1 receptors, but it does not bind IL-1α or IL-1 receptor antagonist (IL-1ra).

Can Ilaris cause birth defects?

Available human data from postmarketing experience and published case reports on Ilaris use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage, and adverse maternal or fetal outcomes. Canakinumab, like other monoclonal antibodies, is actively transported across the placenta mainly during the third trimester of pregnancy and may cause immunosuppression in the in utero exposed infant ( see Clinical Considerations ).

Can Ilaris be discontinued?

Administration of Ilaris should be discontinued if a patient develops a serious infection. Infections, predominantly of the upper respiratory tract, in some instances serious, have been reported with Ilaris. Generally, the observed infections responded to standard therapy.

How many patients were in the IlaRIS trial?

The CAPS trials with ILARIS included a total of 23 pediatric patients with an age range from 4 years to 17 years (11 adolescents were treated subcutaneously with 150 mg, and 12 children were treated with 2 mg/kg based on body weight greater than or equal to 15 kg and less than or equal to 40 kg). The majority of patients achieved improvement in clinical symptoms and objective markers of inflammation (e.g., Serum Amyloid A and C-Reactive Protein). Overall, the efficacy and safety of ILARIS in pediatric and adult patients were comparable. Infections of the upper respiratory tract were the most frequently reported infection. The safety and effectiveness of ILARIS in CAPS patients under 4 years of age has not been established [see Pharmacokinetics (12.3)].

What percentage of patients had a mild tolerability reaction in the CAPS study?

In CAPS Study 1, subcutaneous injection site reactions were observed in 9% of patients in Part 1 with mild tolerability reactions; in Part 2, one patient each (7%) had a mild or a moderate tolerability reaction and, in Part 3, one patient had a mild local tolerability reaction. No severe injection-site reactions were reported and none led to discontinuation of treatment.

Does IL-1 cause malignancies?

The impact of treatment with anti-interleukin-1 (IL-1) therapy on the development of malignancies is not known. However, treatment with immunosuppressants, including ILARIS, may result in an increase in the risk of malignancies.

Is Ilaris a serious infection?

ILARIS has been associated with an increased risk of serious infections. Physicians should exercise caution when administering ILARIS to patients with infections, a history of recurring infections or underlying conditions which may predispose them to infections. ILARIS should not be administered to patients during an active infection requiring medical intervention. Administration of ILARIS should be discontinued if a patient develops a serious infection.Infections, predominantly of the upper respiratory tract, in some instances serious, have been reported with ILARIS. Generally, the observed infections responded to standard therapy. Isolated cases of unusual or opportunistic infections

Does canakinumab cross react with IL-1?

Long-term animal studies have not been performed to evaluate the carcinogenic potential of canakinumab.As canakinumab does not cross-react with rodent IL-1β, male and female fertility was evaluated in a mouse model using a murine analog of canakinumab. Male mice were treated weekly beginning 4 weeks prior to mating and continuing through

Commonly Used Brand Name

Uses For Ilaris

Before Using Ilaris

Proper Use of Ilaris

• A nurse or other trained health professional will give you or your child this medicine in a hospital or clinic setting. This medicine is given as a shot under your skin. This medicine is given every 8 weeks for CAPS and every 4 weeks for TRAPS, HIDS/MKD, FMF, AOSD, and SJIA. This medicine comes with a Medication Guide. It is very important that you...

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Precautions While Using Ilaris

Ilaris Side Effects

Further Information