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Clin Exp Rheumatol. 2016 Mar-Apr;34(2):303-10. Epub 2016 Mar 3.

Glucocorticoid-sparing in patients suffering from rheumatoid arthritis and treated with tocilizumab: the SPARE-1 study.

Author information

1
La Cavale Blanche Hospital, Rheumatology and Université Bretagne Occidentale, Brest; and EA 2216, INSERM ESPRI, ERI29 Université Bretagne Occidentale, Brest, France. alain.saraux@univ-brest.fr.
2
eXYSTAT SAS, Levallois-Perret, France.
3
Roger Salengro Hospital, Rheumatology, Lille, France.
4
Rheumatologist, private office, Gap, France.
5
Rheumatology, Nord Hospital, Amiens, France.
6
Department of Rheumatology, Centre Hospitalier Sud Francilien, Corbeil-Essonnes, France.
7
Chugai, Medical Department, Puteaux, France.
8
Rheumatology, Purpan Hospital, Toulouse, France.

Abstract

OBJECTIVES:

To describe steroid-sparing in rheumatoid arthritis (RA) patients treated with tocilizumab (TCZ).

METHODS:

To evaluate the proportion of RA patients treated with more than 5 mg of prednisone (or equivalent)/day and starting TCZ who can receive less than 5 mg/day after 12 months without intensification of disease-modifying anti-rheumatic drugs (DMARDs), we conducted a non-interventional, multicentre, prospective study from 2011 to 2013. We included patients with moderate-to-severe RA, >18 years old, starting TCZ and receiving corticosteroids (GCs) at a dose greater than 5 mg/day of prednisone for at least 3 months.

RESULTS:

Amongst the 307 analysed patients (78% women, median RA duration: 8 years, mean DAS28-ESR: 5.1±1.3), 40% (95%CI=[35-46]) reached the targeted daily prednisone dose at M12, without conventional synthetic (cs)DMARD intensification. Predictive factors were RA duration of 5 years or less (OR=2.60, p=0.01), daily prednisone dose of 7.5 mg or less (OR=2.12, p=0.03), and low ESR value before the first TCZ infusion (OR=0.86, p=0.047). The proportion of patients with no more GCs increased up to 20% at M12. Disease activity improved over the 1-year period (DAS28-ESR LDA and remission in 41% and 33% of patients at M12, respectively). Amongst the 314 patients analysed for safety, at least one AE and at least one SAE were reported in 211 patients (67%) and in 48 patients (15%), respectively. No unexplained safety signal arose with TCZ.

CONCLUSIONS:

A biological DMARD as TCZ allows reducing both GCs dose and disease activity in RA patients. Nevertheless, corticosteroid spare in real life is probably lower.

PMID:
26941130
[Indexed for MEDLINE]

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