New Labeling for Infused Golimumab; Phase 3 Trial for Romosozumab Promising

Infused Golimumab Receives New Labeling
The U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for golimumab for infusion (Simponi Aria), which treats moderate to severe active rheumatoid arthritis (RA). The labeling will now include improvements in measures of mental and physical health, which were reported by patients through use of the Medical Outcomes Study Short Form-36 (SF-36) questionnaire.¹

According to the newly revised package insert, golimumab for infusion in combination with methotrexate (MTX) improved the physical and emotional wellbeing of patients per the SF-36 assessment. The SF-36 questionnaire helps collect data from patients to aid in assessing health status across a range of physical and mental categories. These data were collected as part of the GO-FURTHER trial. The results revealed that patients receiving golimumab injection and MTX combination therapy had greater improvement from baseline compared with placebo and MTX in all areas of SF-36 at Weeks 12, 16 and 24. These areas included mental component summary scores, physical component summary scores and all eight survey domains: physical function, role limitations due to physical problems, bodily pain, general health perception, vitality, social function, role limitations due to emotional problems and general mental health.

Romosozumab Meets Primary Endpoint for Osteoporosis
Romosozumab, a bone-forming monoclonal antibody, is in Phase 3 clinical trials.² Romosozumab inhibits the protein sclerostin, thereby causing an increase in bone formation and a decrease in bone breakdown.

In a study known as STRUCTURE (aka STudy evaluating effect of RomosozUmab Compared with Teriparatide in postmenopaUsal women with osteoporosis at high risk for fracture pReviously treated with bisphosphonatE therapy), romosozumab met its primary endpoint through Month 12. It demonstrated a statistically significant difference in the percent change of total hip-bone mineral density (measured by DXA) in 436 patients who had previously received bisphosphonates.

This study was an international, randomized, open-label, multi-center, teriparatide-controlled study that evaluated safety, tolerability and efficacy of romosozumab in postmenopausal women with osteoporosis. Patients received either subcutaneous romosozumab at a monthly dose of 210 mg or a daily subcutaneous dose of teriparatide at 20 mcg. No new safety signals for romosozumab were reported. Adverse events that occurred in more than 5% of romosozumab-treated patients were arthralgia, back pain, headache, falls and nasopharyngitis.

Michele B. Kaufman, PharmD, CGP, RPh, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.

References

1. Janssen Biotech Inc. News release: U.S. FDA approves update of Simponi Aria® (golimumab for infusion) label to include improvement in both physical and emotional measures of health when treating moderately to severely active rheumatoid arthritis. PRNewswire. 2015 Sep 2.
2. Amgen Inc. News release: Amgen and UCB announce positive top-line results from open-label phase 3 study of romosozumab compared with teriparatide. 2015 Sep 1.