The new england
journal of medicinen engl j med 389;14 nejm.org October 5, 2023 1263
established in 1812 October 5, 2023 vol. 389 no. 14
From the Hospital for Special Surgery,
Weill Cornell Medical College, New York
(R.F.S.), and Regeneron Pharmaceuti
cals, Tarrytown (A.G., M.C.N., B.A., R.B.,
G.D.Y.) — both in New York; the Vasculi
tis and Glomerulonephritis Center, Mas
sachusetts General Hospital, Harvard
Medical School, Boston (S.U.), and Sano
fi, Cambridge (J.S., N.P.) — both in Mas
sachusetts; the Division of Rheumatol
ogy, Mayo Clinic College of Medicine,
Rochester, MN (K.J.W.); Sanofi, Bridge
water, NJ (W.W., Y.L.); the Department of
Rheumatology and Clinical Immunology,
Charité University Medicine, Berlin (F.B.);
CHRU de Brest, Service de Rhumatolo
gie, Brest (V.D. P.), and Sanofi, Chilly
Mazarin (F.M.) — both in France; the
Division of Rheumatology and Immunol
ogy, Cantonal Hospital St. Gallen, St.
Gallen, Switzerland (A.R. R.); and Anglia
Ruskin University, Cambridge, United
Kingdom (B.D.).
Rheumatology, Hospital for Special Surgery, Be
laire Bldg., 525 E. 71st St., 7th Fl., New
York, NY 10021.
*A list of the SAPHYR investigators is
provided in the Supplementary Appen
dix, available at NEJM.org.
N Engl J Med 2023;389:1263-72.
DOI: 10.1056/NEJMoa2303452
Copyright © 2023 Massachusetts Medical Society.
BACKGROUND
More than half of patients with polymyalgia rheumatica have a relapse during
tapering of glucocorticoid therapy. Previous studies have suggested that interleu-
kin-6 blockade may be clinically useful in the treatment of polymyalgia rheumat-
ica. Sarilumab, a human monoclonal antibody, binds interleukin-6 receptor α and
efficiently blocks the interleukin-6 pathway.
METHODS
In this phase 3 trial, we randomly assigned patients in a 1:1 ratio to receive 52
weeks of a twice-monthly subcutaneous injection of either sarilumab (at a dose of
200 mg) plus a 14-week prednisone taper or placebo plus a 52-week prednisone
taper. The primary outcome at 52 weeks was sustained remission, which was de-
fined as the resolution of signs and symptoms of polymyalgia rheumatica by week
12 and sustained normalization of the C-reactive protein level, absence of disease
flare, and adherence to the prednisone taper from weeks 12 through 52.
RESULTS
A total of 118 patients underwent randomization (60 to receive sarilumab and
58 to receive placebo). At week 52, sustained remission occurred in 28% (17 of
60 patients) in the sarilumab group and in 10% (6 of 58 patients) in the placebo
group (difference, 18 percentage points; 95% confidence interval, 4 to 32; P = 0.02).
The median cumulative glucocorticoid dose at 52 weeks was significantly lower
in the sarilumab group than in the placebo group (777 mg vs. 2044 mg; P<0.001).
The most common adverse events with sarilumab as compared with placebo were
neutropenia (15% vs. 0%), arthralgia (15% vs. 5%), and diarrhea (12% vs. 2%).
More treatment-related discontinuations were observed in the sarilumab group
than in the placebo group (12% vs. 7%).
CONCLUSIONS
Sarilumab showed significant efficacy in achieving sustained remission and reduc-
ing the cumulative glucocorticoid dose in patients with a relapse of polymyalgia
rheumatica during glucocorticoid tapering. (Funded by Sanofi and Regeneron
Pharmaceuticals; SAPHYR ClinicalTrials.gov number, NCT03600818.)
a bs tr ac t
Sarilumab for Relapse of Polymyalgia Rheumatica
during Glucocorticoid Taper
Initial trial of delayed-release prednisalone on PMR
GCA relapse?
Websites - useful stuff, articles, resources
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