Multiple sclerosis (MS) patients with more advanced disease, as evidenced by disability, and those more frequent relapses or aversion to needles are among the groups of people at higher risk of discontinuing Betaferon (interferon beta-1b) treatment, researchers report. These findings may help to alert clinicians to those least likely to adhere to Betaferon treatment, so that adequate support can be given.
In the study, “Risk Factors for Poor Adherence to Betaferon® Treatment in Patients with Relapsing-Remitting Multiple Sclerosis or Clinically Isolated Syndrome,” published in the journal Plos One, the authors aimed to identify possible risk factors for early discontinuation of treatment with Betaferon in patients with relapsing-remitting MS (RRMS) or clinically isolated syndrome (CIS).
Carried out for 24 months, the study included 852 people diagnosed with RRMS or CIS who had started Betaferon therapy 60 or fewer days before its start. Betaferon is administered every other day, subcutaneously by self-injection.
All patients responded to a Risk of Drop-out Questionnaire (RODQ) that takes into account side effects, handling of the drug, trust, and overall treatment support, as well as disease-related factors as progression and relapse, and the importance of treatment. It is intended to help caregivers identify when patients under long-term treatment could encounter difficulties with adherence, and estimate the possible risk of treatment termination.
The patients were also analyzed according to the Center for Epidemiologic Studies Depression Scale (CESD-R) to determine the presence of any depression or depression-associated symptoms. The Kurtzke Expanded Disability Status Scale (EDSS) was used to determine the level of disability caused by the disease.
Overall, researchers observed that younger patients (30.8 years versus 33.7 years), patients with shorter disease duration, those with more advanced disease — as measured by EDSS — and patients who experienced more frequent adverse events presented a higher risk of prematurely stopping therapy. Patients with a greater number of relapses and greater disease progression also stopped the therapy earlier.
Dislike of needles also impacts adherence, the researchers said. “Needle phobia, which affects up to 22% of the general population, may be another significant barrier … to self-administered INFβ therapies among MS patients,” they reported. “The physical disability and cognitive impairment resulting from MS can also make self-injection … difficult. In our study, patients who stopped therapy reported a fear of injection more often than those who adhered to treatment.”
Researchers further observed that the patients who stopped Betaferon therapy in the first year of treatment reported flu-like symptoms and fever, while those who stopped it in the second year more frequently found it to be ineffective and reported MS progression.
“Awareness of these other factors should influence scientifically-evaluated therapy initiation, constant care by professionals, and implementation of follow-up programmes. In conclusion, patients at a higher risk of stopping MS treatment need to be identified early to make support available to them,” the authors concluded.