Clinical Question

Is tocilizumab (Actemra) effective for improving symptoms or reducing prednisone requirements in adults with active polymyalgia rheumatica (PMR) despite ongoing glucocorticoid therapy?

Bottom Line

The study found that intravenous tocilizumab every four weeks for 24 weeks significantly reduced symptoms of active PMR in adults despite ongoing prednisone therapy, resulting in a greater percentage of patients with reduced prednisone requirements. (Level of Evidence = 1b)

Synopsis

Effective alternative treatments for persistent PMR that requires long-term glucocorticoids are needed. The investigators identified adults older than 50 years who met the standard diagnostic criteria for PMR and had a C-reactive protein (CRP) level of at least 10 mg per L or an erythrocyte sedimentation rate of at least 20 mm per hour at disease onset. Eligible patients (N = 101) included those who responded to 12 to 25 mg per day of prednisone to attain a CRP level of less than 10 mg per L or an erythrocyte sedimentation rate of less than 20 mm per hour but subsequently developed glucocorticoid dependency with worsening disease activity after tapering to a prednisone dosage of less than 10 mg per day. Patients randomly received (concealed allocation assignment) an intravenous infusion of tocilizumab (8 mg per kg) every four weeks for 24 weeks or matched placebo. The primary outcome was a composite of disease activity, defined as a PMR activity score computed using the CRP level of less than 10 (range = 0 to 100; higher scores indicate greater disease activity; based on minutes of morning stiffness, ability to elevate upper limbs, physician global assessment, patient-reported pain, and CRP level), and a prednisone dosage of 5 mg per day or less or a prednisone dosage decrease of at least 10 mg vs. baseline. At weeks 12, 16, and 20, prednisone dosages greater than 10 mg per day were tapered by 5 mg. For patients who were already taking prednisone dosages of 10 mg per day or less and whose disease activity scores were less than 10, the prednisone dosage was decreased by 2 mg every two weeks. Individuals masked to treatment group assignment assessed outcomes. Complete follow-up occurred for all patients at 24 weeks.