Drug Updates: Apremilast, Belimumab, and More

Sarilumab (REGN88/SAR153191), a novel, high-affinity, SC-administered, fully human antibody targeting the interleukin-6 receptor (IL-6R), met its primary endpoint in a Phase 2b clinical trial in RA.¹⁴ Patients (n=306) were randomized to receive MTX plus placebo or MTX plus sarilumab (at one of five different doses) for 12 weeks. The primary endpoint was achievement of ACR20, and was attained in 49% of sarilumab-treated patients (at the lowest dose), 72% of sarilumab-treated patients (at the highest dose), and 46% of placebo plus–MTX-treated patients. Secondary endpoints including ACR50, ACR70, and DAS 28 scores also showed significant benefit with sarilumab compared with placebo. The most common side effects in the MTX plus–sarilumab-treated patients were nonserious infections, neutropenia, and liver-function test abnormalities. Serious adverse effects were comparable among the placebo-treated patients and those who received sarilumab. In a Phase 2b study in AS patients who had an inadequate response to NSAIDs, sarilumab did not demonstrate clinically significant or statistically significant improvements in the signs and symptoms of disease.

VX-509, an investigational oral JAK3 inhibitor, met its two primary endpoints in patients with RA in a Phase 2a clinical trial.¹⁵ It was studied in patients (n=204) with active moderate-to-severe RA who had an inadequate response to at least one disease-modifying antirheumatic drug. Patients received either placebo or one of four doses of VX-509, given twice daily for 12 weeks. For the two highest doses, 65% and 66% of VX-509–treated patients achieved an ACR20 versus 29% of placebo-treated patients. Additionally, of the two highest dose levels of VX-509 at Week 12, 35% and 37% of patients, respectively, achieved clinical remission, compared with 7% of placebo-treated patients. A longer-duration trial investigating the potential for additional improvements in RA activity using both once- and twice-daily dosing in combination with methotrexate is planned.

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

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