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Quality of life should be firmly embedded as a treatment goal for patients with schizophrenia. This is according to the Lead Investigator in a unique study that uses the Heinrichs-Carpenter Quality of Life scale (QLS) to compare two long-acting injectables (LAIs) with different modes of action in schizophrenia.
Prof Dieter Naber, Department of Psychiatry and Psychotherapy at the University Medical Centre, Hamburg-Eppendorf, Germany, spoke to the <em><strong>Medical Independent (MI)</strong></em> at the 23rd EPA European Congress of Psychiatry in Vienna, Austria, where he presented on the randomised, head to head QUALIFY study. It found that aripiprazole once-monthly demonstrated non-inferiority and established superiority to another once-monthly atypical antipsychotic, paliperidone palmitate, on health-related quality of life outcomes, as assessed by the Heinrichs-Carpenter QLS.
The QLS scale assesses the impact of deficit symptoms in schizophrenia on patient-reported health-related quality of life (HRQoL). According to the study, the optimisation of a patient’s subjective wellbeing and quality of life should be one of the major goals in the long-term management of schizophrenia.
The QUALIFY study, supported by Otsuka and Lundbeck, is a 28-week, open-label, rater-blinded study in which patients with schizophrenia who needed a change from their current oral antipsychotic treatment were switched to either Abilify Maintena (aripiprazole once-monthly) or paliperidone palmitate.
The primary endpoint results showed a statistically significant difference in improvement from baseline to Week 28 on QLS Total score (4.67 [95%CI: 0.32, 9.02], p=0.036), demonstrating non-inferiority to paliperidone palmitate by pre-specified criteria. Subsequently, as planned in the protocol, superiority of Abilify Maintena to paliperidone palmitate was established. The respective changes from baseline to Week 28 were 7.47 ±1.53 for Abilify Maintena and 2.80 ±1.62 for paliperidone palmitate, with higher scores indicating better quality of life. Changes above 5.0 on the QLS scale can be described as clinically meaningful, meaning that doctors are able to notice improvements in patients in clinical practice.
The primary results were supported by a significant decrease in Clinical Global Impression – Severity scale (CGI-S) scores indicating improvement in clinical symptoms after aripiprazole once-monthly 400 mg compared with paliperidone palmitate once-monthly.
Prof Naber says the results show that Abilify Maintena (aripiprazole) significantly improves outcomes that are essential to patients, their family and caregivers as well as physicians, especially when considering the long-term goals of therapy.
The results demonstrate to physicians that LAIs have “a lot to offer in achieving long-term treatment goals that go beyond symptom control,” he said.
As Prof Naber outlined to <em><strong>MI</strong></em>, there had been interest in quality of life since the availability of antipsychotic treatment, but it took many years for it to become a field of research. One reason for this, he said, was that some clinicians did not believe that patients were able to do a self-rating or believed that they knew their patients “so very well” that this additional information was not required.
In some ways it is a bit surprising, because psychiatry certainly should be a field where we should be interested in everything going on with our patients. So it is a bit remarkable that it took us about 40 years to become interested in the quality of life of schizophrenia patients
“In some ways it is a bit surprising, because psychiatry certainly should be a field where we should be interested in everything going on within our patients. So it is a bit remarkable that it took us about 40 years to become interested in the quality of life of our schizophrenia patients,” he told <em><strong>MI</strong></em>. “It was different for depression — we believed already from the beginning of antidepressants that, of course, depressed patients are able to fill out a self-rating, but as I said, there was a belief that our patients were too ‘crazy’ and it is not worth to listen to them.”
Prof Naber believes attitudes have significantly changed and psychiatrists are increasingly aware of quality of life as a treatment goal.
“We know that we have to inform the patients better and this term ‘shared decision-making’ is now very popular,” he pointed out.
Doctors should discuss with patients the treatment options available and how side-effects may differ with each. This collaboration should also involve informing patients on the choice between oral treatments and LAIs, he said.
As outlined in Prof Naber’s poster at the Congress, schizophrenia is a chronic disease where relapse has severe consequences for patients’ function, and following a relapse it is unlikely that patients will return to previous levels of functioning. LAIs have the potential to improve treatment compliance, reduce the risk of relapse, and consequently preserve the patient’s functioning.
Asked how he sees the QUALIFY study changing clinical practice, Prof Naber told <em><strong>MI</strong></em>: “I think one hope is that we have now data showing that those depots — Abilify Maintena (aripiprazole) as well as paliperidone — are able to not only reduce the symptoms, but also to improve the quality of life. And that I think should stimulate the doctors to offer a depot more often or earlier.”
With more treatment options available, it becomes easier to individualise treatment, he added.
“And that is why I think the more atypical depots available the better, so that the doctor has a good choice.”
As Prof Naber outlined at the Congress in Vienna, patients are willing to accept LAI antipsychotic treatment when properly informed.
However, he referenced a survey of patients with/without LAI antipsychotic experience, which found that 79 per cent of patients without LAI experience cited having never been informed about the option by their psychiatrist (Jaeger & Rossler. <em>Psychiatry Res</em> 2010;175(1–2):58–62).
The issue of LAIs not being offered to patients is probably related to the reputation of the depot from times past, when it was viewed “more a kind of punishment” and when some of the old drugs came with a lot of motor side-effects.
Clinicians today have to “fight the stigma” wrought by this legacy, and that “will certainly take a while”.
<em><strong>MI</strong></em> asked Prof Naber if some psychiatrists may be reluctant to establish an LAI clinic for schizophrenia due to time and resource constraints.
He answered that, when considering health service costs, many studies had shown that good outpatient treatment and better compliance with treatment reduces rehospitalisation considerably.
“Of course these drugs are rather expensive but it is worth the money to spend as you can really reduce rehospitalisation and, at least in Germany now, the biggest sum of money regarding the treatment of schizophrenia still goes for inpatient treatment.”
Prof Naber said patients’ care givers should also be informed about the benefits of LAIs.
“The care givers are usually very critical or complain that the doctors are not interested to talk to the caregiver, they say ‘we never have the opportunity when our son is in hospital to see the doctor’ and that is certainly bad,” he said. “We should include their perspectives. They know the patient so much better than we do because they are together since many years, so it should be our duty to know their experience and to include them in any decision regarding treatment… they are all worried [saying] ‘our son does not take his medication, he is back in the hospital’. So they are all saying ‘hey son, did you take your medication?’ which nobody of course wants to ask… and the son is mad because the parents, again and again, are asking every day.”
If treatment was by injection and the relatives knew that their loved one did not go to their appointment, they would have the opportunity to encourage them to obtain their treatment.
There were “so many good arguments” for LAIs, said Prof Naber, that he admitted surprise that this option was “still not used that often”.
Prof Naber agreed that colleges and professional bodies within psychiatry should be better educating trainees on informing patients and care givers on treatment options.
He added: “As I said, we still have the negative reputation of the depot… particularly with the older psychiatrists. Psychiatrists in some ways are rather conservative and it might take a new generation to finally change their procedures.”
As Prof Naber outlined at the EPA Congress, randomised controlled trials found no differences in study-defined relapse/all-cause discontinuation between LAIs and oral antipsychotics (Kishimoto et al. <em>Schizophr Bull</em> 2014;40(1):192–213).
However, in mirror-image studies, LAIs reduced risk of hospitalisation compared with oral antipsychotics (Kishimoto et al, <em>J Clin Psychiatry</em> 2013;74(10):957–965), while LAI antipsychotics significantly improved treatment outcomes (risk of discontinuation or rehospitalisation) in patients with schizophrenia in a cohort study (Tiihonen et al. <em>Am J Psychiatry</em> 2011;168(6):603–609). Real-world studies favoured the use of LAI antipsychotics (Kirson et al, <em>J Clin Psychiatry</em> 2013;74(6):568–575).
Crucially, non-adherence with antipsychotic treatment was very common in schizophrenia and accounted for most psychotic relapses.
Prof Naber said long-lasting treatment was required to fulfil the most ambitious goals, such as returning to work, having social relationships and living independently, and this was not possible if the patient had to be admitted to hospital every six months.
“I think that is an important issue — long-term treatment without discontinuation, and also psychotherapy and social intervention. All this certainly needs time and if it is interrupted again every six months, then you have to begin at zero every time again.
“I think the more options we have to individualise treatment, the better.”
While an injection was “not the solution to everything”, Prof Naber said he was convinced that, in future years, many more patients would obtain their treatment through LAIs.
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