Ixekizumab is administered subcutaneously at a dose of 160 mg or two 80 mg injections at Week 0, followed by 80 mg injections at Weeks 2, 4, 6, 8, 10 and 12. Patients then receive 80 mg ixekizumab every four weeks.5 In clinical trials, the most common adverse reactions were injection-site reactions, upper respiratory tract infections, nausea and tinea infections.
Belimumab May Reduce Steroid Use in SLE
In pooled data from two large randomized controlled clinical trials, belimumab, the B-lymphocyte stimulator (BLyS)-specific inhibitor, had a moderate association with a greater likelihood of steroid dose reduction over 52 weeks in patients with systemic lupus erythematosus (SLE).6
Compared with placebo-treated patients, dose reduction occurred in 39% of belimumab-treated patients compared to 31% of placebo-treated recipients. Dose augmentation occurred in 18% vs. 31% of belimumab- and placebo-treated patients, respectively. Steroid dose increase occurred in 23% of belimumab-treated patients vs. 35% of placebo-treated patients. The steroid doses decreased in more belimumab-treated patients (37%) than placebo-treated patients (30%).
Romosozumab Effective for Men & Women with Osteoporosis
The Phase 3 BRIDGE (placeBo-contRolled study evaluatIng the efficacy and safety of romosozumab in treatinG mEn with osteoporosis) study recently reported positive top-line results for romosozumab.7 Romosozumab works by inhibiting the protein sclerostin and has a dual effect on bone, both increasing bone formation and decreasing bone resorption.
In the BRIDGE study, men (n=245) were randomized 2:1 to receive either 210 mg romosozumab subcutaneously every month or placebo subcutaneously every month for 12 months. A statistically significant increase in bone mineral density (BMD) at Month 12 compared with placebo-treated patients in the lumbar spine as assessed by dual-energy X-ray absorptiometry was the primary endpoint achieved. The secondary endpoints were also met, which included statistically significant BMD increases at Month 12 at the femoral neck and total hip, as well as statistically significant BMD increases at Month 6 at the lumbar spine, femoral neck and total hip—all compared with placebo-treated patients.
The most frequently reported adverse effects occurring in more than 5% of romosozumab-treated patients were back pain, constipation, headache, hypertension and nasopharyngitis. Injection-site reactions occurred in 5.5% of romosozumab-treated patients and 3.7% of placebo-treated patients; most reactions were mild in severity.
The Phase 3 STRUCTURE (STudy evaluating effect of RomosozUmab Compared with Teriparatide in postmenopaUsal women with osteoporosis at high risk for fracture pReviously treated with bisphosphonatE therapy) study showed statistically significant increases in hip BMD and strength in postmenopausal women with osteoporosis transitioning from bisphosphonate treatment.
