Saturday, June 17, 2017

Sarilumab (ALX-0061) at the 2017 EULAR Annual Meeting in Madrid

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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