Sarilumab - news from EULAR 2012

Sarilumab is a fully human monoclonal antibody directed against IL-6Rα. Here we look at two studies, on on rheumatoid arthritis and one on ankylosing spondylitis.


T.W. Huizinga and colleagues presented a a phase 2, randomized, double-blind, placebo-controlled study on sarilumab for the treatment of moderate to severe rheumatoid arthritis. In results we find: “The percentage of patients with ≥1 treatment emergent adverse event (AE) ranged from 43% to 72% for the sarilumab groups versus 47% for placebo.” It doesn´t look convincing. Also, if you read: “…sarilumab resulted in an improvement in some ACR core components compared to placebo”, you get the feeling of something fishy, so to say.


[OP0023] SARILUMAB FOR THE TREATMENT OF MODERATE-TO-SEVERE RHEUMATOID ARTHRITIS: RESULTS OF A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, INTERNATIONAL STUDY
T.W. Huizinga1, A.J. Kivitz2, M. Rell-Bakalarska3, R.M. Fleischmann4, M. Jasson5, A.R. Radin6, M.C. Genovese7. 1Department of Rheumatology, Leiden University Medical Centre, Leiden, Netherlands; 2Department of Rheumatology, Altoona Center for Clinical Research, Duncansville, United States; 3Rheumatology and Osteoporosis Outpatient Clinic, Warsaw, Poland; 41. Metroplex Clinical Research Center, Dallas, United States; 5Sanofi, Paris, France; 6Translational Medicine, Regeneron Pharmaceuticals, Inc., Tarrytown; 7Immunology & Rheumatology, Stanford University Medical Center, Palo Alto, United States
Conclusions: In this phase 2 study, sarilumab 150 mg qw, in combination with methotrexate, demonstrated efficacy in patients with active, moderate-to-severe rheumatoid arthritis, who had inadequate response to MTX. Moreover, for the doses that were selected for phase 3 (150 and 200 mg q2w), sarilumab resulted in an improvement in some ACR core components compared to placebo. The types and incidence of adverse events were consistent with those previously reported with IL-6 inhibition. MOBILITY Part B (SARIL-RA-MOBILITY) the phase 3 portion of the seamless study will assess long-term efficacy of sarilumab in rheumatoid arthritis.
Clinical trial identifier: NTC01061736


J. Sieper an colleagues presented a phase 2, randomized. double-blind, placebo-controlled study (acronym: ALIGN) of sarilumab for the treatment of ankylosing spondylitis. Sorry, but: “The study failed to demonstrate the efficacy of sarilumab in patients with AS assessed by ASAS20 response.”


[OP0169] SARILUMAB FOR THE TREATMENT OF ANKYLOSING SPONDYLITIS: RESULTS OF A PHASE 2, RANDOMIZED. DOUBLE-BLIND, PLACEBO-CONTROLLED, INTERNATIONAL STUDY (ALIGN)
J. Sieper1, R.D. Inman2, S. Badalamenti3, A. Radin4, J. Braun5. 1Rheumatology, Charite University Medicine Berlin, Berlin, Germany; 2Immunology, The Toronto Hospital Western Division, Toronto, Canada; 3Clinical Research, Sanofi, Bridgewater; 4Translational Medicine, Regeneron Pharmaceuticals, Inc., Tarrytown, United States; 5Rheumazentrum Ruhrgebiet, Herne, Germany
Conclusions: The study failed to demonstrate the efficacy of sarilumab in patients with AS assessed by ASAS20 response. Sarilumab was generally well-tolerated. In patients with a high baseline hsCRP, a trend was noted in the percentage of patients achieving ASAS20 only in the highest dose of sarilumab (150 mg qw) compared to patients in the placebo arm.
Clinical Trial Identifier: NTC01061723


I doubt that Sarilumab will be launched soon. Maybe someone finds a useful target for the drug, but it seems that rheumatoid arthritis and ankylosing spondylitis can´t be treated effectively with sarilimumab.