My first encounter with sarilumab has been in
2011 at the ACR Annual Meeting in Chicago [1]. I had been quite disappointed at
the 2012 ACR Annual Meeting in Washington [2]. At the 2015 ACR Annual Meeting
in San Francisco sarilumab had been presented by several studies, but I still
saw the need of data on radiographic progression [3].
There have been 10 studies on sarilumab
presented at the 2017 EULAR Annual Meeting in Madrid.
M.C. Genovese and colleagues presented this
study [4]: “ASSOCIATION BETWEEN CLINICAL AND RADIOGRAPHIC RESPONSES, AND
PHYSICAL FUNCTION IN A PHASE 3 STUDY OF SARILUMAB PLUS METHOTREXATE IN PATIENTS
WITH ACTIVE, MODERATE-TO-SEVERE RHEUMATOID ARTHRITIS”. Conclusions: “Achieving
LDA [low disease activity] or remission, or absence of radiographic
progression, was associated with overall greater improvement in physical
function. Irrespective of whether patients achieved remission or LDA, SARILUMAB
+ MTX [methotrexate] showed greater improvements in HAQ-DI [health assessment
questionnaire disability index] than Pbo [placebo] + MTX.”
G.R. Burmester and colleagues presented [5]:
“EFFICACY AND SAFETY OF SARILUMAB MONOTHERAPY VERSUS ADALIMUMAB MONOTHERAPY IN
PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS IN THE PHASE 3 MONARCH STUDY,
INCLUDING SUBPOPULATIONS”. Conclusions: “SARILUMAB monotherapy demonstrated
superiority to adalimumab monotherapy in the ITT [intention to treat] population
in change from baseline in DAS28-ESR [disease activity score (for rheumatoid
arthritis) on 28 joints, erythrocyte sedimentation rate]. The extent of
treatment effect with SARILUMAB vs adalimumab was generally consistent across
subpopulations. Overall incidences of AEs [adverse events] and serious AEs and rates
of infection and serious infection were similar between groups”. This would
have been expected as tocilizumab showed superiority versus adalimumab (C.
Gabay and colleagues published [6]: “Tocilizumab monotherapy versus adalimumab
monotherapy for treatment of rheumatoid arthritis (ADACTA): a randomised,
double-blind, controlled phase 4 trial”.).
Sarilumab (Kevzara) received FDA approval on
May 22, 2017. Sanofi and Regeneron Pharmaceuticals announced in April 2017, that
the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human
Use (CHMP) has adopted a positive opinion for the marketing authorization of Sarilumab
(Kevzara).
Now, that the time is approaching for sarilumab to come to the market, I still ask myself: Do I need sarilumab? What
could sarilumab give us, which we can’t get from tocilizumab? Will I split up
my IL-6 inhibitor patients in two groups? Still I can’t answer these questions.
Links and
References:
[4] Annals of the Rheumatic Diseases, volume
76, supplement 2, year 2017, page 576 / Session: Rheumatoid arthritis - other
biologic treatment , (Poster Presentations) / DOI:
10.1136/annrheumdis-2017-eular.3513
[5] Annals of the Rheumatic Diseases, volume
76, supplement 2, year 2017, page 849 / Session: Rheumatoid arthritis - other
biologic treatment , (Poster Presentations) / DOI:
10.1136/annrheumdis-2017-eular.4540
.
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