MEET CONSULTANT NEUROLOGIST DR HEIDI BIERNAT
A Consultant neurologist Dr Heidi Biernat Bispebjerg University Hospital Copenhagen
TOURETTE, TOLERABILITY AND SEPRANOLONE
Consultant Neurologist Dr. Heidi Biernat is Head of the Tourette Clinic in the Department of Neurology at Copenhagen’s Bispebjerg University Hospital, and Principal Investigator for Asarina’s phase IIa study in Sepranolone for Tourette syndrome. Here she talks about the challenges of today’s TS treatments, patient response to Sepranolone and how she sees its potential as a first-choice treatment for pharmaceutical intervention in Tourette Syndrome.
“I first realized that I wanted to become a movement disorder neurologist very early on, when I first met Parkinson’s patients,” says Dr. Heidi Biernat. “Bispebjerg is very specialized in movement disorders, with an impressive record in treating adult Tourette. When I took over as head of the Tourette Clinic in 2010, we had 80 adult TS patients, now we have around 450, some who travel from across Denmark for treatment.”
POSITIVE PATIENT RESPONSE TO FIRST CLINICAL TOURETTE STUDY
Asarina Pharma’s phase IIa study was the first pharmaceutical trial for TS to be run at the Clinic. The study was run by Dr Biernat, who was a part of a team of two doctors, two nurses and a staff nurse. The unmet need for a treatment that is not an antipsychotic, and that can be both effective and tolerable over the middle- and long-term, meant that patient interest and engagement was high from the beginning:
“When the trial was announced we had a very positive response from patients. All those who took part are now interested in participating again in a phase IIb study. Many of our adult TS patients manage a job and family life with Tics, which takes a huge amount of hard work. As Tics wax and wane, patients go through cycles of having challenging periods where they need antipsychotics, which often have tremendous side effects which limit how long you can stay on them. Coming off the medication again means a return of Tics which can lead to problems with work and family life, before necessitating a bout of new treatment. So many patients have been interested in a safer pharmaceutical treatment for a long time.”
“We had a very positive response when the trial was announced. Our first candidate overcame a severe needle phobia to take part. Many patients have been interested in a safer pharmaceutical treatment for a long time. Everyone who took part is interested in participating again in a phase IIb study.”
Dr Heidi Biernat, Bispebjerg University Hospital
COMPLIANCE A KEY CHALLENGE FOR ANTIPSYCHOTICS
“The side effects with antipsychotics are so heavy that very few patients keep taking them for long periods if they can be avoided. Presently doctors shy away from antipsychotics because the burden of side effects, plus monitoring for those side effects, is so heavy – to be honest most patients are just not interested in those kinds of medication”, Consultant Neurologist Dr Heidi Biernat.
The Standard of Care (SoC) treatment for the patients taking part in the study was either antipsychotics or CBIT-based counselling for Tic management. The limited treatment options currently available, and the lack of a safe pharmaceutical treatment, were highly motivating for patients, Dr Biernat says. The dropout rate was unusually low (7%), with just two patients dropping out – one from the control group, one from the active group.
HOW DID DR BIERNAT SEE ADHERENCE WITH SEPRANOLONE?
COMPREHENSIVE BEHAVIORAL INTERVENTION FOR TICS (CBIT)
Dr Biernat is a keen advocate for CBIT, but points out that here too there can be challenges for compliance. CBIT is a demanding treatment requiring long-term commitment and discipline. The 10-week long initial training program, requiring regular follow-up, is labor-intensive to administer. (Waiting lists for CBIT across Europe are long in a healthcare landscape struggling with staff shortages, difficulty retaining staff and tighter spending limits and cuts.)
“CBIT is excellent, and really helps people understand their relationship to ticcing and their own processes. However, its success depends on an individual’s capacity to work with cognitive instruments, and many people find it difficult to keep up in the long run. They often get a reduction in the initial 10 weeks, they are very content with that, and then they let it slide a little. For some patients it works, for others it requires a lot of concentration and discipline over a long time, and many will stop. There is a capacity challenge too. Our nurses also have a lot of Parkinson’s patients and patients with other chronic conditions to treat, so we can only have a few Tourette patients go through the CBIT system at a time. Our nurses have to be agile and flexible.”
“The side effects with antipsychotics are so heavy that very few patients keep taking them for long periods if they can be avoided. With Sepranolone the lack of side effects was very motivating.”
Dr Heidi Biernat, Bispebjerg University Hospital
“I feel urgently that there should be a phase IIb study. I think that the effects of Sepranolone on those patients who have OCD symptoms in addition to their tics, in particular deserves to be further explored. These are the clients who suffer most from impairment and reduced quality of life. For patients I saw that Sepranolone really had a magnificent effect.”Consultant neurologist Dr Heidi Biernat Bispebjerg University Hospital Copenhagen
OCD AND STANDOUT MEMORIES
“The effects of Sepranolone on those patients who have OCD symptoms in addition to their tics really deserves to be further explored. Some effects were so positive that I asked myself whether I should put the legal processes into motion for some patients in order to allow them to continue with the treatment after the study.
“SEPRANOLONE GIVES US A NEW OPTION. I BELIEVE IT HAS A STRONG FUTURE”.
In conclusion Dr Biernat believes that Sepranolone has strong potential for becoming a new first choice for pharmaceutical intervention for Tourette for those patients who are not managing on CBIT.
“I can easily see Sepranolone becoming the new first-line treatment for Tourette patients who cannot manage their tics with CBIT and who require pharmaceutical treatment” she says. “As a practitioner we really need this treatment. When I see my colleagues try to prescribe for tics they still often have to go back to the old-fashioned antipsychotics, and people don’t like it, they can’t sustain those treatments because of severe side effects. Sepranolone gives us a new option. I believe it has a strong future”.