Abstract
Objective: To compare interferon β-1b (IFNβ-1b) and glatiramer acetate (GA) on new lesion (NL) (gadolinium-enhancing, new T2) evolution into permanent black holes (PBH)-a marker of irreversible tissue damage-in patients with relapsing-remitting multiple sclerosis (RRMS). Methods: BEYOND was a large, phase III, clinical trial comparing IFNβ-1b 250 μg, IFNβ-1b 500 μg, and GA (2:2:1). Patient scans were reexamined post hoc for PBH in a rater-blinded manner. Two predefined coprimary endpoints compared IFNβ-1b 250 μg with GA: first, number of PBH per patient at year 2 evolving from year 1 NL, then proportion of year 1 NL evolving into PBH at year 2. IFNβ-1b 500 μg and GA were compared in an exploratory fashion. Results: Approximately 90% (1,957/2,244) of patients had NL at year 1 with follow-up at year 2. Mean numbers of PBH per patient at year 2 evolving from year 1 NL were lower for IFNβ-1b 250 μg than GA (0.30 vs 0.43; p = 0.0451). The proportion of NL evolving into PBH was similar (IFNβ-1b 250 μg vs GA: 21.6% vs 23.5%; p > 0.20). For IFNβ-1b 500 μg, both the mean PBH number per patient at year 2 evolving from year 1 NL (0.26 vs 0.43; p = 0.0037) and proportion of NL evolving into PBH (16.3% vs 23.5%; p = 0.0409) were lower relative to GA. Conclusion: IFNβ-1b affected PBH development to a similar or better extent than GA. IFNβ-1b favorably influences an MRI outcome indicative of permanent tissue destruction in the brains of patients with multiple sclerosis. Classification of evidence: This study provides Class III evidence that IFNβ-1b is associated with a reduction in MRI PBH formation and evolution compared with GA between years 1 and 2 of treatment.
| Original language | English |
|---|---|
| Pages (from-to) | 1222-1228 |
| Number of pages | 7 |
| Journal | Neurology |
| Volume | 76 |
| Issue number | 14 |
| DOIs | |
| Publication status | Published - Apr 5 2011 |
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ASJC Scopus subject areas
- Clinical Neurology
Cite this
Interferon β-1b and glatiramer acetate effects on permanent black hole evolution. / Filippi, M.; Rocca, M. A.; Camesasca, F.; Cook, S.; O'Connor, P.; Arnason, B. G W; Kappos, L.; Goodin, D.; Jeffery, D.; Hartung, H. P.; Comi, G.; Wolinsky, J. S.; Bogumil, T.; Pohl, C.; Beckmann, K.; Sandbrink, R.; Croze, E.; Brown, C.; Desimone, T. M.; Arnold, D. L.; Cutter, G.; Knappertz, V.
In: Neurology, Vol. 76, No. 14, 05.04.2011, p. 1222-1228.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Interferon β-1b and glatiramer acetate effects on permanent black hole evolution
AU - Filippi, M.
AU - Rocca, M. A.
AU - Camesasca, F.
AU - Cook, S.
AU - O'Connor, P.
AU - Arnason, B. G W
AU - Kappos, L.
AU - Goodin, D.
AU - Jeffery, D.
AU - Hartung, H. P.
AU - Comi, G.
AU - Wolinsky, J. S.
AU - Bogumil, T.
AU - Pohl, C.
AU - Beckmann, K.
AU - Sandbrink, R.
AU - Croze, E.
AU - Brown, C.
AU - Desimone, T. M.
AU - Arnold, D. L.
AU - Cutter, G.
AU - Knappertz, V.
PY - 2011/4/5
Y1 - 2011/4/5
N2 - Objective: To compare interferon β-1b (IFNβ-1b) and glatiramer acetate (GA) on new lesion (NL) (gadolinium-enhancing, new T2) evolution into permanent black holes (PBH)-a marker of irreversible tissue damage-in patients with relapsing-remitting multiple sclerosis (RRMS). Methods: BEYOND was a large, phase III, clinical trial comparing IFNβ-1b 250 μg, IFNβ-1b 500 μg, and GA (2:2:1). Patient scans were reexamined post hoc for PBH in a rater-blinded manner. Two predefined coprimary endpoints compared IFNβ-1b 250 μg with GA: first, number of PBH per patient at year 2 evolving from year 1 NL, then proportion of year 1 NL evolving into PBH at year 2. IFNβ-1b 500 μg and GA were compared in an exploratory fashion. Results: Approximately 90% (1,957/2,244) of patients had NL at year 1 with follow-up at year 2. Mean numbers of PBH per patient at year 2 evolving from year 1 NL were lower for IFNβ-1b 250 μg than GA (0.30 vs 0.43; p = 0.0451). The proportion of NL evolving into PBH was similar (IFNβ-1b 250 μg vs GA: 21.6% vs 23.5%; p > 0.20). For IFNβ-1b 500 μg, both the mean PBH number per patient at year 2 evolving from year 1 NL (0.26 vs 0.43; p = 0.0037) and proportion of NL evolving into PBH (16.3% vs 23.5%; p = 0.0409) were lower relative to GA. Conclusion: IFNβ-1b affected PBH development to a similar or better extent than GA. IFNβ-1b favorably influences an MRI outcome indicative of permanent tissue destruction in the brains of patients with multiple sclerosis. Classification of evidence: This study provides Class III evidence that IFNβ-1b is associated with a reduction in MRI PBH formation and evolution compared with GA between years 1 and 2 of treatment.
AB - Objective: To compare interferon β-1b (IFNβ-1b) and glatiramer acetate (GA) on new lesion (NL) (gadolinium-enhancing, new T2) evolution into permanent black holes (PBH)-a marker of irreversible tissue damage-in patients with relapsing-remitting multiple sclerosis (RRMS). Methods: BEYOND was a large, phase III, clinical trial comparing IFNβ-1b 250 μg, IFNβ-1b 500 μg, and GA (2:2:1). Patient scans were reexamined post hoc for PBH in a rater-blinded manner. Two predefined coprimary endpoints compared IFNβ-1b 250 μg with GA: first, number of PBH per patient at year 2 evolving from year 1 NL, then proportion of year 1 NL evolving into PBH at year 2. IFNβ-1b 500 μg and GA were compared in an exploratory fashion. Results: Approximately 90% (1,957/2,244) of patients had NL at year 1 with follow-up at year 2. Mean numbers of PBH per patient at year 2 evolving from year 1 NL were lower for IFNβ-1b 250 μg than GA (0.30 vs 0.43; p = 0.0451). The proportion of NL evolving into PBH was similar (IFNβ-1b 250 μg vs GA: 21.6% vs 23.5%; p > 0.20). For IFNβ-1b 500 μg, both the mean PBH number per patient at year 2 evolving from year 1 NL (0.26 vs 0.43; p = 0.0037) and proportion of NL evolving into PBH (16.3% vs 23.5%; p = 0.0409) were lower relative to GA. Conclusion: IFNβ-1b affected PBH development to a similar or better extent than GA. IFNβ-1b favorably influences an MRI outcome indicative of permanent tissue destruction in the brains of patients with multiple sclerosis. Classification of evidence: This study provides Class III evidence that IFNβ-1b is associated with a reduction in MRI PBH formation and evolution compared with GA between years 1 and 2 of treatment.
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UR - http://www.scopus.com/inward/citedby.url?scp=79954574768&partnerID=8YFLogxK
U2 - 10.1212/WNL.0b013e3182143577
DO - 10.1212/WNL.0b013e3182143577
M3 - Article
C2 - 21464426
AN - SCOPUS:79954574768
VL - 76
SP - 1222
EP - 1228
JO - Neurology
JF - Neurology
SN - 0028-3878
IS - 14
ER -