There has been one
publication on tregalizumab at the ACR 2015 Annual Meeting in San Francisco. “Tregalizumab
(BT-061) is a humanized, anti-CD4 mAb, inducing selective Treg activation in
vitro.” It seems an interesting concept, as the authors of the study point out:
“Previous trials suggested efficacy in RA at doses ≥25 mg subcutaneously (SC).”
But let’s come to the dismal truths of the study.
Ronald F. van Vollenhoven and colleagues presented: “A Phase 2b Study
Evaluating the Efficacy and Safety of Subcutaneously Administered Tregalizumab
in Subjects with Active Rheumatoid Arthritis (RA) Despite Treatment with
Methotrexate (MTX)”. But they had to
conclude: “No tested doses of tregalizumab demonstrated significant efficacy
improving signs and symptoms of active RA based on ACR20 responses at wk 12 and
24 despite dose dependent down-modulation of CD4 expression. Tregalizumab was
generally well tolerated.”
Does this mean, that
tregalizumab should be abandoned? I guess not. Maybe Tregs act differently in
vivo. And I guess, the team around Ronald F. van Vollenhoven will come out with
a new idea, on how to make the concept work. Maybe it only works in a form of
combination. Looking forward to new developments with tregalizumab.
References:
van Vollenhoven RF,
Keystone EC, Strand V, Pacheco-Tena C, Vencovsky J, Behrens F, Zipp D,
Rharbaoui F, Wolter R, Tiemann RD, Knierim L, Schmeidl R, Zhou X, Aigner S,
Daelken B, Wartenberg-Demand A. A Phase 2b Study Evaluating the Efficacy and
Safety of Subcutaneously Administered Tregalizumab in Subjects with Active
Rheumatoid Arthritis (RA) Despite Treatment with Methotrexate (MTX) [abstract].
Arthritis Rheumatol. 2015; 67
(suppl 10).
http://acrabstracts.org/abstract/a-phase-2b-study-evaluating-the-efficacy-and-safety-of-subcutaneously-administered-tregalizumab-in-subjects-with-active-rheumatoid-arthritis-ra-despite-treatment-with-methotrexate-mtx/.
Accessed November 19, 2015.
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