Pipeline & Drug Approvals
Baricitinib (LY3009104), an oral Janus kinase (JAK) 1 and 2 enzyme inhibitor, is currently in Phase 3 clinical trials for treating rheumatoid arthritis (RA).1 Presented at the 2013 EULAR Annual European Congress of Rheumatology, 52-week baricitinib safety and efficacy data from an open-label, long-term extension of the Phase 2b JADA study in baricitinib-treated patients with active RA (n=201) showed clinical improvements at Week 24, sustained at the end of Week 52.2 Through Week 12 of the study, patients received either daily baricitinib 1 mg, 2 mg, 4 mg, or 8 mg, or placebo. During Weeks 12 to 24, patients initially randomized to placebo or baricitinib 1 mg were re-randomized to receive either 2 mg twice daily or 4 mg once daily (for 12 weeks); patients who were initially randomized to receive baricitinib 2 mg, 4 mg or 8 mg continued to receive those doses. In the long-term extension, patients received either once daily 4 mg (n=108) or 8 mg (n=93) baricitinib starting at Week 24 through Week 52.
Treatment-emergent adverse effects (AEs) included infections (n=34) and serious infections (n=2). No tuberculosis or opportunistic infections were observed. One death occurred in the 8 mg group due to a suspected myocardial infarction.
Esomeprazole 20 mg (generic Nexium) will soon be available for over-the-counter (OTC) heartburn treatment.3 This OTC product has three-year market exclusivity.
Tocilizumab (Actemra) is currently in Phase 3 clinical trials for treating polyarticular-course juvenile idiopathic arthritis (pc-JIA).4 PC-JIA patients who had active disease greater than or equal to six months with an inadequate methotrexate (MTX) response were treated with open-label tocilizumab every four weeks (8 mg/kg body weight [BW; n=34] or 10 mg/kg for BW <30 kg [n=35] and 8 mg/kg for BW ≥30 kg [n=119]). Patients who at Week 16 had ≥ JIA-ACR30 improvement entered a 24-week, double-blind phase in which they were randomized to receive either tocilizumab (stratified by MTX and steroid background therapy; n=82) or placebo (n=81). The primary endpoint was JIA flare compared to Week 16. Patients who had a disease flare, or completed this second study phase, received open-label tocilizumab. Disease flares occurred in 26% of tocilizumab-treated patients and 48% of placebo-treated patients. At the end of the second phase of the study, 65% of tocilizumab-treated patients had a JIA-ACR70 and 45% of tocilizumab-treated patients had a JIA-ACR90. Patients in this study ranged in age from 6.9 (±3.02) to 13.1 (±2.78) years. Common AEs were pneumonia, bronchitis and cellulitis. No deaths or malignancies were reported.