Baricitinib Does Well Against Placebo and Adalimumab

Morning joint stiffness and fatigue aren’t what you would call “sexy” in the world of orthopedics. But for millions of rheumatoid arthritis (RA) patients, it’s an ugly daily reality. New results, however, indicate that patients treated with baricitinib, as compared to placebo and adalimumab (Humira), had significant improvements in patient-reported outcomes, including joint pain, severity of morning joint stiffness and tiredness. These results, which emanate from two phase 3 trials (RA-BEAM and RA-BUILD), were announced by Eli Lilly and Company and Incyte Corporation.

According to the November 14, 2106 news release, “In the RA-BEAM (can’t find out what this means!) trial, once-daily baricitinib (4 mg) significantly improved joint pain, severity of morning joint stiffness and tiredness, compared to placebo, as early as day three and significantly improved duration of morning joint stiffness by day five. With the same dose of baricitinib, these improvements were significantly greater than adalimumab by day 17 (joint pain), day 19 (severity of morning joint stiffness) and day 21 (tiredness).”

“The 52-week RA-BEAM study randomized 1, 307 patients who had active, moderate-to-severe RA, despite ongoing treatment with methotrexate. Patients were randomized to once-daily placebo (n=488), once-daily baricitinib 4 mg (n=487) or biweekly adalimumab 40 mg (n=330). All patients received background methotrexate. At week 24, patients taking placebo were crossed over to the baricitinib treatment group.”

“In the RA-BUILD trial, baricitinib (4 mg) significantly improved joint pain, severity and duration of morning joint stiffness and tiredness by days 4, 4, 10 and 3, respectively, compared to placebo. In RA-BUILD, the incidence of SAEs [serious adverse events] with baricitinib treatment, including serious infections, was similar to placebo. There were no gastrointestinal perforations in the study. A single case of tuberculosis was reported in a patient receiving baricitinib. The most common adverse events observed were consistent with previous studies of baricitinib in RA. Discontinuation rates due to adverse events were similar between treatment groups.”

“The RA-BUILD study enrolled 684 patients with moderate-to-severe RA who previously had an inadequate response to, or were intolerant of, at least one conventional synthetic disease-modifying antirheumatic drug (csDMARD) and had not received a biologic DMARD. Patients received either once-daily baricitinib (2 mg or 4 mg) or placebo, in addition to their background therapy.”

Terence Rooney, M.D., is Lilly’s senior medical director for baricitinib. He told OTW, “Once-daily, oral baricitinib demonstrated early response compared to placebo and significant improvement compared to adalimumab in patient-reported outcomes, including joint pain, severity of morning joint stiffness and tiredness, in people with RA. As orthopedic surgeons likely know, these are common and debilitating symptoms that RA patients face in their everyday lives. These new results are very encouraging for healthcare professionals and patients alike, and further support baricitinib as a potential next generation oral treatment for those living with RA.

“It’s promising to see the fast response rheumatoid arthritis patients had with baricitinib treatment. Significant improvement in joint pain, severity of morning joint stiffness and tiredness was seen in patients treated with baricitinib, compared to placebo, as early as day 3. Baricitinib also significantly improved joint pain, severity of morning joint stiffness and tiredness in RA patients who had inadequate response to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), including methotrexate, compared to adalimumab within 3 weeks of treatment.”