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24th November 2021
Byannli (paliperidone palmitate) is the first long-acting injectable agent to be approved by the European Medicine Agency (EMA) for the maintenance treatment of schizophrenia in adult patients, deemed clinically stable and already prescribed injectable paliperidone palmitate given either monthly or 3‑monthly.
Schizophrenia is a chronic and severe mental illness that affects around 20 million people worldwide. The illness is characterised by distorted thinking, perception, emotions, language, sense of self and behaviour. Among sufferers, common experiences will include hallucinations, such as seeing or hearing things which are invisible or inaudible to others together with fixed and false beliefs, i.e., delusions. Typically, patients experience an initial period in which some deterioration in personal functioning and emergence of negative symptoms occurs, followed by an acute phase with both positive and negative symptoms that can interfere with daily functioning.
Treatment is aimed at reducing the acute phase symptoms and trying to return patients to their normal state. However, for many individuals, non-adherence to treatment is a major barrier to successful disease control with identified drivers of non-adherence including lack of insight, medication beliefs and substance abuse. These factors combine to increase the risk of relapse and in fact, treatment relapse with a gap of between 11 and 30 days has been associated with a nearly three-fold increased risk of hospitalisation. Consequently, most patients with schizophrenia require maintenance treatment.
Several anti-psychotic agents are available, one of which is Byannli (paliperidone palmitate), which is available as both an oral an injectable form and has usually been administered either monthly or three-monthly. A clear advantage of long-acting over oral therapy, particularly among schizophrenic patients, is that blood levels of the drug remain stable over time, which reduces the risk of a relapse.
The EMA approval was based on the results of the Route 6 study with paliperidone palmitate in 702 adults (ages 18–70) with schizophrenia. The purpose of the study was to show that the efficacy of 6-monthly, PP6M (700 or 1000mg) of Byannli were non-inferior to a three-monthly (PP3M) regime preventing relapse in participants with schizophrenia who were previously stabilised on corresponding doses of the drug given either monthly (100 or 150mg) or three-monthly (350 or 525mg). In the trial all stabilised adult patients (n=702) were randomised in a 2:1 ratio to receive a six-monthly (n = 478) or three-monthly (n = 224) dose of the drug. The primary outcome was the time to first relapse which was defined as psychiatric hospitalisation, increase in positive and negative syndrome scale (PANSS) total score, increase in individual PANSS item scores, violent behaviour resulting in self-injury or suicidal/homicidal ideation.
The results showed non-inferiority of PP6M compared with PP3M on the primary endpoint of time to first relapse at the end of the 12-month period. Results showed that 92.5% of patients treated with PP6M and 95.1% treated with PP3M were relapse-free at 12 months. In addition, the safety profile observed for PP6M was consistent with previous studies with no new safety signals emerging.
The EMA approval follows a similar approval by the FDA in September 2021.
22nd November 2021
The European Medicines Agency (EMA) has approved the use of risankizumab (brand name Skyrizi) for the treatment of patients with active psoriatic arthritis (PsA) who have failed to adequately response to one or more disease modifying anti-rheumatic drugs (DMARDs) or who are intolerant to DMARDs.
Psoriatic arthritis is an inflammatory arthritis affecting the joints and connective tissue which is associated with psoriasis and which is present on the skin or nails. While the prevalence of psoriasis in the general population is low, at around 3%, at least 20% of psoriasis patients have PsA which is a progressive disease that ranges from mild synovitis to severe erosive arthropathy. Sufferers of PsA experience joint inflammation which causes swelling and pain and which has a negative impact on their quality of life.
The treatment of PsA starts with non-steroidal anti-inflammatories and as the disease progresses, escalates to oral corticosteroids, DMARDs and finally biologic agents. There are currently several biologics approved for the management of PsA including ixekizumab and guselkumab. Skyrizi was previously approved by the EMA in 2019 for the treatment of plaque psoriasis but that has been extended to include PsA.
The EMA approval of Skyrizi (risankizumab) was based the findings of two Phase III clinical trials, KEEPsAKE-1 and KEEPsAKE-2. Both trials were placebo-controlled trials in patients with moderate to severe PsA although KEEPsAKE-1 included patients with an inadequate respond to one or more DMARDs whereas KEEPsAKE-2 recruited those with an inadequate response to other biologicals. In both trials patients received skyrizi at subcutaneous dose of 150 mg and the primary outcome for both studies was the ‘percentage of Participants Achieving at least 20% Improvement in American College of Rheumatology (ACR20)‘.
The ACR20 is a composite measure defined as both improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure [most often Health Assessment Questionnaire (HAQ)], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).
In both trials, the ACR20 response was set as the primary endpoint and assessed after 24 weeks. Secondary endpoints included the Health assessment questionnaire disability index (HAD-DI), which represents a measure of physical function and the proportion of patients achieving minimal disease activity (MDA).
In KEEPsAKE-1 (KS1) and KEEPsAKE-2 (KS2), 57.3% and 51.3% of patients respectively, given risankizumab achieved the primary endpoint compared to 33.5% and 26.5% receiving placebo (p<0.001).
Similarly, improvements in HAQ-DI of -0.31 (KSI) and -0.22 (KS2) compared with -0.11 and -0.05, in the respective placebo groups was seen at week 24 (p<0.001). Finally, 25% (KS1) and 25.6% (KS2) of Skyrizi patients achieved MDA, compared to 10.2% (KS1) and 11.4% (KS2) of those on placebo (p<0.001).
In terms of safety, serious adverse events occurred in 2.5% (KS1) and 4% (KS2) of patients given Skyrizi although this was comparable to the placebo rate (3.7% and 5.5%, KSI and KS2).
According to the EMA approval, Skyrizi can be used either alone or in combination with methotrexate.
Source. Abbvie press release. 17th November 2021