Effects of multiple sclerosis injection therapy turning to oral therapy: a national queue study

Injection therapy, β interferon (IFN beta) and gratilamycin acetate (GA), is the only option for first-line treatment for multiple sclerosis (MS).
with the advent of new oral first-line therapies, these drugs have become a popular option for first-line therapies, or as alternatives for patients who are already on injection therapy.
in the presence of the disease, conversion therapy has been shown to improve clinical outcomes, and treatment escalation has a greater impact on disease activity than conversion to drugs with similar efficacy.
While it is often unavoidable to switch treatments in patients with intolerable side effects, serious adverse events or taboos, some patients or doctors may consider switching treatments in other situations, such as safety issues such as pregnancy, or cost-related causes.
these cases, evidence of the risk of disease activity associated with conversion is needed to guide patients and doctors in their decisions.
the study, we looked at the effects of converting stable relapsed remission-relieving multiple sclerosis (RRMS) patients with injection therapy to oral therapy with similar efficacy.
specifically, the clinical results from injection therapy (IFN beta/GA) to Teflon (TFL) or dimethyl fumarate (DMF) were compared.
all treatments using Disease Improvement Therapy (DMT) in Denmark are recorded in the Multiple Sclerosis Registry (DMSR), as well as clinical parameter data entered by therapeutic neuroscientists.
must enter data for all clinical visits, which are usually conducted at the beginning of treatment, three months later, and every six months thereafter.
Registry enriches data on demographics, immigration and life conditions through the registry's personal contacts, and according to neuroradiologists, data on MRI parameters are forward-lookingly entered by therapeutic neurologists during clinical visits.
patients with clinically stable RRMS were included in injection therapy at least 1 year before the baseline examination.
based on the initial treatment, they were divided into two groups.
in order to include all potential risk times associated with conversion, the baseline of conversion therapy is defined as the date on which the previous treatment was discontinued.
these definitions apply to DMF and TFL in Denmark in 2014.
this paper looked at patients from baseline to death, immigration, or the last valid EDSS scoring date.
if a patient does not visit a clinic with an effective EDSS score for 3 years or more, the patient is considered to have lost follow-up at the previous visit.
result was a six-month diagnosis of EDSS deterioration, defined as an increase in EDSS scores confirmed by two consecutive visits at least six months apart.
EDSS increase is defined as: patients with a baseline EDSS score of 0 ≥1.5 points, and patients with a baseline EDSS score of 1 or more ≥1 point.
secondary results include the time of the first recurrence and the annualized recurrence rate (ARRs), which are compared between the exposure groups.
recurrence within 30 days of each other is considered a single event, and the time of the event is defined as the first occurrence of two events.
used available MRI data to further assess the timing of primary re-recurring and first treatment recurrence in a group of patients.
The patient needs an effective baseline MRI (between 6 months before the baseline check and 60 days after the baseline check) that contains the number of new or expanded T2 lesions compared to the "pre-baseline" scan performed in the first 6 months of the baseline check.
MRI data is used to ensure that there is no MRI activity during baseline checks, defined as no new or expanded T2 lesions during baseline checks, and no new or expanded T2 lesions recorded by MRI during the first 12 months of baseline checks.
3,206 patients were included in the study, of which 1,543 were included in the DMF conversion analysis and 1,663 were included in the TFL conversion analysis.
follow-up analysis into DMF and TFL, a total of 363 cases and 396 six-month confirmed EDSS deterioration were observed.
1.15 (95% CI 0.88 to 1.50, difference p=0.31) and 1.16 (95% CI 0.92 to 1.46, difference p=0.21), respectively.
follow-up period, 278 and 260 recurrences were reported in DMF and TFL analyses, respectively.
for DMF and TFL, the conversion hours are 0.73 (95% CI 0.51 to 1.04) and 1.25 (95% CI 0.96 to 1.63), respectively.
subgroups with effective and inactive MRI information included 77 DMF patients (19 transiters, 58 transiters) and 89 TFL patients (32 transiters, 57 transiters).
for DMF, no increase in EDSS deterioration rates (HR 0.67, 95% CI 0.21 to 2.17) was observed for DMF, and the trend of first recurrence time was similar to that of the main analysis (HR 0.35, 95% CI 0.08 to 1.50).
for TFL, no difference was found between the six-month-diagnosed EDSS deterioration (HR 0.76, 95% CI 0.28 to 2.07) or the first recurrence (HR 0.90, 95% CI 0.32 to 2.52).
there is no evidence of an increased risk of worsening disability from injection therapy, i.e. interferon β or GA, to first-line oral therapy, DMF or TFL.
who switch from injection to DMF may have a lower recurrence rate after switching to DMF treatment.
In patients who switched to TFL, there was a slight increase in the risk of first relapse, although this finding did not reach formal statistically significant levels and was not repeated in MSM analysis or ARRs recurrence event analysis over time.
Consistent with these findings, the risk of interruption of treatment due to disease activity was lower in patients who switched to DMF, and we found that the trend of higher rates of interruption of treatment due to disease activity was statistically less significant in patients who switched to TFL.
patients who switched to TFL had a relatively low risk of discontinuing treatment due to adverse events.
limitation of this study is the relative lack of MRI data.
Buron MD, Kalincik T, Sellebjerg F, et al Effect of lateral therapyrapy switches to oral moderate-efficacy drugs in multiple sclerosis: a nation cohort study Journal of Neurology, Neurosurgery Psython Published Online First: 12 January 2021. doi:10.1136/jnnp-2020-324869MedSci Original Source: MedSci Original Copyright Notice: All notes on this website "Source: Met Medical" or "Source: MedSci Original" text, images and audio and video materials, copyrighted by Mace Medical, not authorized No media, website or individual may be reproduced, and authorization must be made with the "Source: Metz Medicine" in the authorizing the reprint.
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