The following data were presented at the American College of Rheumatology/Association of Rheumatology Health Professionals meeting in Washington.
Eli Lilly and Co., of Indianapolis, and Incyte Corp., of Wilmington, Del., said that in two phase III trials, RA-BEAM and RA-BUILD, patients with rheumatoid arthritis treated with baricitinib experienced significant improvements in patient-reported outcomes, including joint pain, severity of morning joint stiffness and tiredness, compared to placebo and Humira (adalimumab, Abbvie Inc.). Baricitinib is a once-daily oral selective JAK1 and JAK2 inhibitor currently in late-stage studies for inflammatory and autoimmune diseases.
Morphosys AG, of Martinsried, Germany, said licensee Janssen Research & Development LLC, a unit of New Brunswick, N.J.-based Johnson & Johnson, presented results from a phase IIa study testing guselkumab, a fully human anti-IL-23 monoclonal antibody, in the treatment of active psoriatic arthritis. Data showed a substantially higher percentage of patients receiving guselkumab achieved at least a 20 percent improvement in signs and symptoms of the disease, or ACR20, at week 24, the study’s primary endpoint, compared with patients receiving placebo. Results also showed statistically significant improvements in all secondary endpoints, including physical function, psoriatic skin lesions and other health-related outcomes in patients treated with guselkumab compared with patients receiving placebo.
Pfizer Inc., of New York, reported results from the phase III OPAL (Oral Psoriatic Arthritis Trial) studies, Broaden and Beyond, testing JAK inhibitor Xeljanz (tofacitinib citrate) in adult patients with active psoriatic arthritis who had an inadequate response (IR) to conventional synthetic disease-modifying antirheumatic drugs or to tumor necrosis factor inhibitors, respectively. Both studies met their primary efficacy endpoints showing a statistically significant improvement with tofacitinib 5 mg and 10 mg twice daily compared to treatment with placebo at three months as measured by ACR20 response (OPAL Broaden: p≤0.05 and p<0.0001; OPAL Beyond: p<0.0001, respectively), and change from baseline in Health Assessment Questionnaire Disability Index score (OPAL Broaden: p≤0.05 and p<0.001; OPAL Beyond: p<0.0001 and p<0.001, respectively).
Samumed LLC, of San Diego, said a phase I trial testing its Wnt pathway modulator, SM04690, demonstrated potential for cartilage regeneration, as well as improvements in pain and function associated with osteoarthritis of the knee. In the modified intent-to-treat population at 24 weeks, subjects in the 0.07-mg cohort showed a statistically significant increase in mean medial joint space width (JSW) of 0.49 mm (SD ±0.75 mm, p=0.02) from baseline compared to placebo. Clinicians generally perceive an increase in joint space as evidence of potential preservation or regeneration of cartilage. From baseline to 24 weeks, no change in mean medial JSW was observed in the 0.03-mg cohort, a decrease in mean medial JSW of 0.15 mm was observed in the 0.23-mg cohort and a mean decrease of 0.33 mm was observed in the placebo cohort. A phase II study of SM04690 is ongoing. In a separate presentation, Samumed reported in vitro and in vivo results showing the potential of SM04690 in degenerative disc disease. SM04690 induced the proliferation and differentiation of nucleus pulposus (NP)-derived progenitor cells into chondrocyte-like NP cells, which are essential to the proper functioning of intervertebral discs, providing both structure and hydration. Phase I testing in that indication is expected to start next year.
UCB SA, of Brussels, Belgium, said The Lancet published full results from EXXELERATE, the first head-to-head superiority study of two treatments in the anti-TNF class, comparing Cimzia (certolizumab pegol) plus methotrexate (MTX) to Humira (adalimumab, Abbvie Inc.) plus MTX in adult patients with moderate to severe rheumatoid arthritis who were inadequate responders to MTX. The study did not meet its primary endpoints for superiority, demonstrating no statistically significant difference in efficacy between the two drugs in combination with MTX in both short-term (12-week) and long-term (two-year) evaluations. However, data from the study demonstrated that switching between those anti-TNFs without a washout period was beneficial to some patients.