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#Post#: 3443--------------------------------------------------
(Abst.) ECTRIMS: Effectiveness of initial MS treatments...
By: agate Date: October 23, 2021, 6:21 pm
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Presented at the annual ECTRIMS conference this month:
Effectiveness of initial MS treatments in the COMBAT-MS trial:
injectables, dimethyl fumarate, natalizumab and
rituximab[font=arial]P. Alping[sup]1,2[/sup], J.
Burman[sup]3[/sup], K. Fink[sup]1,4[/sup], A.
Fogdell-Hahn[sup]1[/sup], M. Gunnarsson[sup]5[/sup], J.
Hillert[sup]1,6[/sup], A. Langer-Gould[sup]7[/sup], J.
Lycke[sup]8[/sup], P. Nilsson[sup]9[/sup], T.
Olsson[sup]1,4[/sup], J. Salzer[sup]10[/sup], A.
Svenningsson[sup]11[/sup], M. Vrethem[sup]12[/sup], T.
Frisell[sup]2[/sup], F. Piehl[sup]1,4[/sup][/font]
[font=arial][sup]1[/sup]Karolinska Institutet, Department of
Clinical Neuroscience, Stockholm, Sweden, [sup]2[/sup]Karolinska
Institutet, Clinical Epidemiology Division, Department of
Medicine Solna, Stockholm, Sweden, [sup]3[/sup]Uppsala
University, Department of Neuroscience, Uppsala, Sweden,
[sup]4[/sup]Stockholm Health Services, Academic Specialist
Centre, Stockholm, Sweden, [sup]5[/sup]Örebro University,
Department of Neurology, Faculty of Medicine and Health, Örebro,
Sweden, [sup]6[/sup]Karolinska University Hospital, Department
of Neurology, Stockholm, Sweden, [sup]7[/sup]Kaiser Permanente,
Clinical and Translational Neuroscience, Southern California
Permanente Medical Group, Pasadena, United States,
[sup]8[/sup]University of Gothenburg, Department of Clinical
Neuroscience, Gothenburg, Sweden, [sup]9[/sup]Lund University,
Department of Clinical Sciences/Neurology, Lund, Sweden,
[sup]10[/sup]Umeå University, Department of Pharmacology and
Clinical Neuroscience, Umeå, Sweden, [sup]11[/sup]Karolinska
Institutet, Danderyd Hospital, Department of Clinical Sciences,
Stockholm, Sweden, [sup]12[/sup]Linköping University, Department
of Clinical and Experimental Medicine, Linköping, Sweden[/font]
[font=arial]Introduction: Direct comparisons across multiple
disease-modifying therapies (DMTs) for relapsing-remitting
multiple sclerosis (RRMS) are valuable in clinical decision
making. COMBAT-MS (NCT03193866) is an observational drug trial
capturing data on clinical relapses, lesions on magnetic
resonance imaging (MRI), Expanded Disability Status Scale
(EDSS), and drug survival, at all Swedish university
clinics.[/font]
[font=arial]Objective: Compare the effectiveness of the most
common initial MS therapies in Sweden.[/font]
[font=arial]Methods: All first-ever MS treatments with
injectables (INJ, interferon-β/glatiramer acetate),
dimethyl fumarate (DMF), natalizumab (NTZ), and rituximab (RTX),
started 2011-01-01 to 2020-12-14, were identified with
prospectively recorded outcome data in the Swedish MS Register.
Follow-up continued even if the therapy ended. Missing data were
imputed using multiple imputation and potential confounding was
adjusted for using stabilized inverse probability of treatment
weighting with baseline variables: age, sex, MS duration,
geographical region, EDSS, and relapses. All comparisons are
made against RTX.[/font]
[font=arial]Results: We included 1936 first-ever therapy
episodes: 856 INJ, 341 DMF, 270 NTZ, and 469 RTX. Baseline
characteristics differed by DMT, with natalizumab having the
youngest patients, shortest MS duration, and the most previous
relapses.[/font]
[font=arial]After adjustment, the hazard ratio (HR) for first
relapse vs RTX was for INJ 5.9 (95% confidence interval 3.7;
9.5), DMF 2.8 (1.7; 4.8), and NTZ 1.8 (1.0; 3.3). Similarly, the
relative three-year lesion rate was for INJ 6.06 (3.75; 9.80),
DMF 3.52 (2.01; 6.17), and NTZ 2.03 (1.14; 3.64). EDSS
differences at three years were only marginally different: INJ
0.25 (0.06; 0.44), DMF 0.05 (-0.16; 0.26), and NTZ 0.00 (-0.23;
0.24). In contrast, HR for treatment discontinuation was marked:
INJ 32.5 (19.0; 55.7), DMF 20.2 (11.5; 35.4), and NTZ 16.2 (8.9;
29.5).[/font]
[font=arial]Conclusions: In treatment-naïve patients, RTX was
associated with the lowest risk of relapses and MRI lesions, and
by far the lowest probability of switching to a second therapy.
In contrast, EDSS at 3 years was similar for RTX, DMF, and NTZ,
and only slightly higher for INJ. The apparent difference in
effectiveness between NTZ and RTX could possibly be explained by
the vulnerable period after switching from NTZ, mainly due to JC
virus positivity. These findings underscore the importance of
tracking long-term outcomes from first DMT start, while
considering subsequent therapy switches.[/font]
[font=arial]Disclosure[/font]
[font=arial]This study was funded through a Patient-Centered
Outcomes Research Institute Award (MS-1511–33196); the
statements presented in this publication are solely the
responsibility of the authors and do not necessarily represent
the views of the Patient-Centered Outcomes Research Institute,
its Board of Governors or Methodology Committee. It was also
supported by the Swedish Research Council and NEURO Sweden (TF).
The funding sources had no role in the study design; in the
collection, analysis, and interpretation of data; in the writing
of the report; or in the decision to submit the paper for
publication.[/font]
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