ECTRIMS 2010
Data from the Phase II study of ofatumumab in relapsing remitting multiple sclerosis will be presented at the 26th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Goteborg, Sweden on October 16, 2010 from 9:15 to 9:30am local time during Paralell Session 10 "Late Breaking News." The abstract will be available on the ECTRIMS website at www.congrex.ch/ectrims2010 on October 13, 2010.
Data from the Phase II study of ofatumumab in relapsing remitting multiple sclerosis will be presented at the 26th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Goteborg, Sweden on October 16, 2010 from 9:15 to 9:30am local time during Paralell Session 10 "Late Breaking News." The abstract will be available on the ECTRIMS website at www.congrex.ch/ectrims2010 on October 13, 2010.
Vedrørende zalu:
Severe anaphylactic reactions have been reported
after treatment with several different monoclonal
antibodies, but the mechanism of these reactions
has not been defined, and their rates have generally
been less than 1%.1-5,7,8,22 Our results show
that most of the severe hypersensitivity reactions
to cetuximab in the subjects we studied were associated
with IgE antibodies against galactose-α-
1,3-galactose that were present before treatment
with cetuximab. The assay we used identified 17
of the 21 subjects whose treatment had to be discontinued
after the first infusion because of a hypersensitivity
reaction.
Unlike most other monoclonal antibodies, cetuximab
is produced in the mouse cell line SP2/0,
which expresses the gene for α-1,3-galactosyltransferase.
17,18 The evidence that IgE antibodies that
are specific for the post-translational modification
of a molecule can cause severe infusion reactions
may have relevance for an understanding of allergic
responses to other recombinant molecules.
Severe anaphylactic reactions have been reported
after treatment with several different monoclonal
antibodies, but the mechanism of these reactions
has not been defined, and their rates have generally
been less than 1%.1-5,7,8,22 Our results show
that most of the severe hypersensitivity reactions
to cetuximab in the subjects we studied were associated
with IgE antibodies against galactose-α-
1,3-galactose that were present before treatment
with cetuximab. The assay we used identified 17
of the 21 subjects whose treatment had to be discontinued
after the first infusion because of a hypersensitivity
reaction.
Unlike most other monoclonal antibodies, cetuximab
is produced in the mouse cell line SP2/0,
which expresses the gene for α-1,3-galactosyltransferase.
17,18 The evidence that IgE antibodies that
are specific for the post-translational modification
of a molecule can cause severe infusion reactions
may have relevance for an understanding of allergic
responses to other recombinant molecules.
21/9 2010 07:47 gentogen 0
33723 Jeg har ikke hørt fremlæggelsen fra i går, men synes, at det ser stærkt ud.Cetuximab har tydeligvis visse problemer og de kommer mere og mere frem i lyset. Se for eksempel denne fra 2010!:
http://www.supportiveoncology.net/journal/articles/0802072.pdf
Så bedre sikkerhedsprofilo med zalu må have stor betydning:
Konklusion fra ovenstående:
Conclusion
This study provides further evidence that the clinically relevant
rate of cetuximab HIR (HIR = HYPERSENSITIV INFUSIONS REAKTION, gentogen)exceeds that initially reported.
With a high incidence of such reactions in the Southeastern
United States and few routine clinical, demographic, or historic
variables reliably predicting HIRs, strong consideration must
be given to refining clinical management of these patients.
Incorporation of a test dose of cetuximab with close clinical
monitoring for HIRs may provide a safe and effective way to
use staff and financial resources. Premedication use should
include both H1 antagonists and IV steroids. Alternatively,
panitumumab may be considered a reasonable substitution
for cetuximab in this high-risk geographic population, particularly
for patients with CRC receiving palliative monotherapy.
Additional research is needed prior to routine substitution of
panitumumab for cetuximab. Further studies may help us to
understand better the etiology of cetuximab HIR and to validate
the benefit of test dosing. Results of prospective studies
incorporating IgE testing are eagerly awaited; thus, reliable
and reproducible laboratory-based assays may prospectively
identify those at highest risk.
Acknowledgments: We are indebted to B. McMichael for administrative
assistance with the formatting of this article. We wish to
thank all current and former members of the US military and their
families for their service and sacrifice for our country
http://www.supportiveoncology.net/journal/articles/0802072.pdf
Så bedre sikkerhedsprofilo med zalu må have stor betydning:
Konklusion fra ovenstående:
Conclusion
This study provides further evidence that the clinically relevant
rate of cetuximab HIR (HIR = HYPERSENSITIV INFUSIONS REAKTION, gentogen)exceeds that initially reported.
With a high incidence of such reactions in the Southeastern
United States and few routine clinical, demographic, or historic
variables reliably predicting HIRs, strong consideration must
be given to refining clinical management of these patients.
Incorporation of a test dose of cetuximab with close clinical
monitoring for HIRs may provide a safe and effective way to
use staff and financial resources. Premedication use should
include both H1 antagonists and IV steroids. Alternatively,
panitumumab may be considered a reasonable substitution
for cetuximab in this high-risk geographic population, particularly
for patients with CRC receiving palliative monotherapy.
Additional research is needed prior to routine substitution of
panitumumab for cetuximab. Further studies may help us to
understand better the etiology of cetuximab HIR and to validate
the benefit of test dosing. Results of prospective studies
incorporating IgE testing are eagerly awaited; thus, reliable
and reproducible laboratory-based assays may prospectively
identify those at highest risk.
Acknowledgments: We are indebted to B. McMichael for administrative
assistance with the formatting of this article. We wish to
thank all current and former members of the US military and their
families for their service and sacrifice for our country
23/9 2010 11:22 gentogen 033832 ECTRIMS 16/10
09:00 - 09:15 Magnetic resonance imaging (MRI) efficacy of ofatumumab in relapsing-remitting multiple sclerosis (RRMS) – 24-week results of a phase II study 136
P. Soelberg Sorensen, J. Drulovic, E. Havrdova, S. Lisby, O. Graff, S. Shackelford (Copenhagen, DK; Belgrade, RS; Prague, CZ; RTP, US)
09:00 - 09:15 Magnetic resonance imaging (MRI) efficacy of ofatumumab in relapsing-remitting multiple sclerosis (RRMS) – 24-week results of a phase II study 136
P. Soelberg Sorensen, J. Drulovic, E. Havrdova, S. Lisby, O. Graff, S. Shackelford (Copenhagen, DK; Belgrade, RS; Prague, CZ; RTP, US)
det ligner et forsøg designet til at vise effekt i RRMS som primært endpoint. Nok også et dosis studie?
Det forrige havde jo safety som primært endpoint.
Det forrige havde jo safety som primært endpoint.
23/9 2010 15:18 colombuss 033843 Mærkeligt man ikke kan lave den slags stuier, samtidigt med at man måler en reel effekt?
23/9 2010 16:39 gentogen 033849 Det skulle måske have været forklaret lidt bedre. beklager. Der er tale om titel og navne på en præsentation, som Genmab gennemfører d. 16/10 på en konference i Sverige om studiet i RRMS.
