Reported at EULAR, patients fared better in early (less than two years in duration) RA outcomes when treated with a combination of 8 mg monthly tocilizumab plus methotrexate (MTX) than with either agent as monotherapy, during this 104-week study.7 The Health Assessment Questionnaire Disability Index (HAQ-DI) was used to assess outcomes. Patients were randomized to received tocilizumab 4 mg or 8 mg once monthly plus MTX, monotherapy with 8 mg tocilizumab monthly or MTX monotherapy.8 Most patients were women with a mean age of 50 years. The short form (SF)–36 measured changes from baseline from the evaluated time points. A 100 mm visual analog scale was used in which baseline pain scores were around 60 and patient global assessments were around 65. This was a Phase 3 trial, FUNCTION, which included 1,157 methotrexate-naive patients. Improvements on rating scales were noted as early as two weeks into therapy and were highest for the 8 mg tocilizumab-plus-MTX group. By the end of Year 1, combination-therapy-treated patients had decreases of 43 points on the pain scale and 46 points on the patient-reported global assessment compared with MTX-monotherapy patients of 35 and 37 points, respectively. ACR-defined responders included 68% on combination therapy, 60% on tocilizumab monotherapy and 52% on MTX monotherapy. MTX-naive early RA patients showed improvement across all patient-reported outcomes, including physical function, fatigue, pain and quality of life, with combination-therapy-treated patients showing unfailingly greater numerical improvements compared with MTX-monotherapy-treated patients.
Drug Safety
Femoral fractures have been linked to bisphosphonates. This adherence study evaluated Medicare, fee-for-service, female (n=522, 287) beneficiaries from 2006–2010.9 Medication possession ratio (MPR) was used as a measure of medication adherence. An MPR of less than one-third was considered to be less compliant. An MPR greater than or equal to one-third or less than two-thirds was considered adherent, and an MPR greater than two-thirds was considered highly adherent. Alternative cutoff points at 50% and 80% were also used. Cumulative incidence and hazard of subtrochanteric/femoral shaft (ST/FS) or intertrochanteric/femoral neck (IT/FN) fractures were also determined. A graded increase in the incidence of ST/FS fractures was noted as the adherence level increased (Gray’s test, P < 0.001). The researchers estimated that during the fourth year of bisphosphonate treatment there was an increase of 76 per 100,000 in the rate of ST/FS fractures and a decrease of 312 per 100,000 in the rate of IT/FN fractures. The authors believed that these study results support the hypothesis that cumulative exposure to oral bisphosphonates may be causally related to ST/FS fractures.
