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Asian Journal of Biomedical and Pharmaceutical Sciences | Volume 8
March 26-27, 2018 | Orlando, USA
World Summit on
Healthcare & Hospital Management
&
International Conference & Exhibition on
Biologics and Biosimilars
B
iosimilars represent a new tendency in the treatment of
many immune-mediated inflammatory diseases, including
psoriasis. Regulatory requirements for approval of biosimilars
are different from those of originators and rely mostly upon
the evidence generated from bioequivalence studies and in
particular fromRCT, as an important part of it. In our study, case
series, we tried to correlate the immunogenicity (measured
with ELISA method: Antidrug antibodies and drug level) on
eight patients on Inflectra (Infliximab biosimilar), treated more
than eight months in our Dermatology Clinic. Our goal was to
determine the evolution of the inflammatory markers (ESR,
PCR) together with the evolution of PASI, PASI50 and PASI90
on a case series of eight patients for eight months. We were
also capable to evaluate the possible correlations between
these indices and immunogenicity. We found an interesting
fact that from these eight patients, two had sub-therapeutically
drug level but not anti-Infliximab antibodies. One of these two
patients had also elevated inflammatory markers and the other
one has gainedmore than 10kgs. Peculiar is also the finding that
the third patient developed anti-infliximab-antibodies as well
as sub-therapeutically trough level of Infliximab. Two months
later, we evaluate the same parameters and we found no anti-
infliximab antibodies and therapeutically through level. There
is some discussion in the literature regarding the transient anti-
drug antibodies and therefore the need to repeat them when
positive and mainly when the clinical appearance does not
explain the paraclinical findings. Our study concluded that, even
on small clinical trial you can find valuable information that can
help to tailor the treatment for the patient.
Speaker Biography
Rodica Olteanu is a Dermatologist and Medical Director of Colentina Clinical
Hospital, Bucharest, Romania. She has received her PhD on lupus research in 2007,
in collaboration with Hamburg University. She is involved in autoimmunity and
immunogenicity of biologics and biosimilars and published more than 100 papers in
lupus and psoriasis. She is Alumni EADV Club rewarded, winner of many international
grants, Member in EADV Project Committee, AAD, GRAPPA, EuSCLE, SRD, ILDS Member
and Member in Editorial Board of SRD and LAJPPA. She has completed her educational
training by participating at Master Class on Psoriasis- Barcelona, Center for Excellence
in Psoriasis-Vienna, Pearls in Lisbon and Bucharest-as Invited Speaker and also at
Harvard. She supports the idea of a collaborative work group of specialists in different
areas for autoimmune diseases also with patient’s participation and she intent to
create an Autoimmune Diseases Center in Colentina Hospital.
e:
rodicaolteanu@hotmail.comRodica Olteanu
Colentina Clinical Hospital, Romania
Inflectra-Our experience on immunogenicity (Case series)