• Amgen Inc., of Thousand Oaks, Calif., reported top-line results from its Phase III EVOLVE (EValuation Of Cinacalcet HCL Therapy to Lower CardioVascular Events) trial, which showed that patients with secondary hyperparathyroidism (HPT) and chronic kidney disease (CKD) on dialysis who received Sensipar/Mimpara (cinacalcet) experienced numerically fewer composite events – comprising all-cause mortality or first nonfatal cardiovascular event – when compared to placebo, though the study fell short of statistical significance, failing to meet the primary endpoint in the intent-to-treat analysis. Sensipar/Mimpara, an oral calcimimetic, is approved for treating secondary HPT in patients with CKD receiving dialysis. The EVOLVE trial enrolled 3,883 patients who were receiving dialysis and was designed to determine whether the drug could reduce the risk of mortality and cardiovascular events in that patient population.

• ChemoCentryx Inc., of Mountain View, Calif., reported Phase II data showing that CCX354, a selective, oral inhibitor of chemokine receptor CCR1, was generally well tolerated by patients with rheumatoid arthritis and showed evidence of clinical activity using the ACR20 response criteria at week 12. The response was 56 percent in patients receiving 200 mg CCX354 once daily, compared to 44 percent in patients receiving 100 mg twice daily and 30 percent in patients receiving placebo. The difference between the 200-mg dose group and placebo was statistically significant (p = 0.014). Data from the trial, dubbed CARAT-2, also indicated that CCX354 treatment reduced biomarkers of bone turnover. Those results were published in the Annals of Rheumatic Diseases.

• Immunomedics Inc., of Morris Plains, N.J., reported data from the ALLEVIATE trials testing epratuzumab, including results from the open-label extension study showing clinically meaningful improvements in health-related quality of life for patients with systemic lupus erythematosus, sustained over two years of treatment. Separate data from a post-hoc exploratory analysis showed that the proportion of patients who experienced flares in the ALLEVIATE trials was highest in the placebo group (37.8 percent vs. 30 percent in the epratuzumab 360-mg group and 9. 1 percent in the epratuzumab 720-mg group). In EMBLEM, a later dose-finding trial, the proportion of patients experiencing a flare was low in all groups, with small differences between groups: 5.3 percent for placebo, 7.7 percent for the 100-mg every other week (EOW) group, 5.3 percent for the 400-mg EOW group, 5.7 percent for the 600-mg weekly group, 8.1 percent for the 1,200-mg EOW group and 5.3 percent for the 1,800-mg EOW group. Those and other data were presented at the European League Against Rheumatism meeting in Berlin. Immunomedics' partner UCB SA, of Brussels, Belgium, is testing epratuzumab, a humanized anti-CD22 antibody, in two Phase III studies in patients with moderate or severe lupus.

• Incyte Corp., of Wilmington, Del., and Eli Lilly and Co., of Indianapolis, presented 12-week results from a Phase IIb study of baricitinib, formerly LY3009104 (INCB28050), an orally available janus kinase (JAK) inhibitor, in patients with active rheumatoid arthritis (RA) at the European League Against Rheumatism's (EULAR) Annual European Congress of Rheumatology last week. The randomized double-blind, placebo-controlled, dose-ranging study (JADA) involved 301 patients with active RA on stable doses of methotrexate. Patients were randomized to receive either placebo or one of four once-daily doses of baricitinib (1 mg, 2 mg, 4 mg or 8 mg) for 12 weeks. The primary endpoint was achieved, demonstrating a statistically significant difference in the American College of Rheumatology 20 response between the combined 4-mg and 8-mg baricitinib groups (76 percent) compared with placebo (41 percent) after 12 weeks of treatment (p < 0.001).

• PTC Therapeutics Inc., of South Plainfield, N.J., reported results from a Phase III study of ataluren, an investigational new drug, in patients with nonsense mutation cystic fibrosis (nmCF), which demonstrated positive trends in lung function as measured by forced expiratory volume in one second (FEV1) and in the secondary outcome measure, rate of pulmonary exacerbations. Results also showed a substantial ataluren treatment effect in FEV1 and exacerbation rate in the pre-specified subpopulation of patients not receiving chronic inhaled antibiotics, representing approximately one-half of the study population. Those data were presented at the European Cystic Fibrosis Society Conference in Dublin, Ireland.