Patients with rheumatoid arthritis who had inadequate response to previous biologic disease-modifying antirheumatic drugs found greater pain relief when taking 2 mg or 4 mg of baricitinib compared with placebo.
Patients with rheumatoid arthritis who had an inadequate response to previous biologic disease-modifying antirheumatic drugs (bDMARDs) found greater pain relief when taking 2 mg or 4 mg of baricitinib compared with placebo, according to the results of a new study presented at the 2018 ACR/ARHP Annual Meeting, October 19-24, 2018, in Chicago, Illinois.
Patients with rheumatoid arthritis often experience pain and this impacts negatively on their quality of life. In a phase 3 study (RA-BEACON) of patients with rheumatoid arthritis on a conventional DMARD who experienced adequate response or intolerance 1 or more tumor necrosis factor (TNF) inhibitors, once-daily baricitinib (2 mg and 4 mg) demonstrated significant clinical improvements in patients, compared with placebo; however, baricitinib’s impact on pain was not assessed. Therefore, investigators led by Janet E. Pope MD, MPH, FRCPC, professor of medicine, division of rheumatology and epidemiology and biostatistics, University of Western Ontario, Schulich School of Medicine in London, Ontario, Canada, and division head of rheumatology at St. Joseph’s Health Centre, also in London, conducted a post hoc analysis of the RA-BEACON data to “characterize the effects of baricitinib on pain relief by baseline pain and rheumatoid arthritis treatment history,” according to the study abstract. In an interview with MD Magazine®, Pope further explained how at least 50% of patients with rheumatoid arthritis will need more advanced therapy over the course of their lifetime in addition to methotrexate, which may aid in assessing a major unmet need in treating these patients, pain (see video).
A total of 527 patients were included in the study, of which, 176 were randomized to placebo, 174 received 2 mg of baricitinib and 177 received 4 mg of baricitinib, all once-daily for 24 weeks. The primary endpoint was assessment of pain at week 12. Pain was assessed at each visit using a visual analog scale (VAS, 0-100 mm). About 40% of patients had received more than 1 TNF inhibitor already, and about 25% had received 3 or more biologic DMARDs.
“These were a tough group of patients to treat,” explained Pope. “They had to have active rheumatoid arthritis, and they had been through several different lines of therapy previously. More than half had already experienced more than 1 TNF-inhibitor.”
The mean baseline pain scores in the group were 65 for those patients in the placebo group, 62 for those patients in the baricitinib 2 mg group, and 66 for those patients in th3 baricitinib 4 mg group.
At week 12, patients were assessed at achieving either >30%, >50%, or >70% pain relief across both doses of baricitinib and placebo and the proportion of patients achieving each was compared using logistic models. “The treatment comparisons within each subgroup category (pain < median  vs ≥median, number of prior TNF inhibitors [1 vs >1] and prior bDMARDs [<3 vs ≥3]) on pain relief were performed. Missing pain values were imputed using modified last observation-carried-forward (mLOCF),” wrote the authors.
The results indicated that significantly more patients achieved ≥30%, ≥50%, and ≥70% pain relief with baricitinib 2 mg or baricitinib 4 mg than those taking placebo (P<.05, for all comparisons), and the results were consistent, regardless of baseline pain scores, shared Pope (see video).
Next steps for this research may include comparing the effects of other medications on pain to determine if there is a preference among 1 or another for certain patients, or, determining what could potentially be added to a patient’s treatment regimen to address the seriously unmet need of pain (see video).
J. E. Pope, AbbVie Inc, Amgen Inc, Bristol-Myers Squibb, Lilly, Merck & Co, Novartis, Pfizer, Inc, Roche, Sanofi
Pope JE, Quebe A, Zhu B, Sun L, Gaich CL, de Leonardis F, Cardoso A, Genovese MC. Assessment of Pain Relief with Baricitinib By Treatment History in Patients with Refractory Rheumatoid Arthritis [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 10). https://acrabstracts.org/abstract/assessment-of-pain-relief-with-baricitinib-by-treatment-history-in-patients-with-refractory-rheumatoid-arthritis/. Accessed October 24, 2018.