Adding tofacitinib to treatment with disease-modifying anti-rheumatic drugs (DMARDs) may help improve symptoms in patients with active rheumatoid arthritis (RA). Nonbiologic DMARDs, including methotrexate, are commonly used to treat RA. However, DMARDs alone do not always adequately treat the disease.
Tofacitinib is a novel, oral, Janus kinase inhibitor that treats RA. Researchers sought to determine the safety and efficacy of tofacitinib taken in combination with nonbiologic DMRDs.
Patients with inadequately controlled RA (n = 792) despite treatment with nonbiologic DMARDs were randomly assigned to one of four twice-daily treatment sequences: 5 mg of tofacitinib; 10 mg of tofacitinib; placebo advanced to 5 mg of tofacitinib; or placebo advanced to 10 mg of tofacitinib.
The study showed that when used in combination with various nonbiologic DMARDs, tofacitinib, 5 mg and 10 mg twice daily, compared with placebo, rapidly reduced the signs and symptoms of RA and improved physical function. Adverse events included decreases in neutrophil counts, increases in high- and low-density lipoprotein cholesterol level, and small increases in serum creatinine and aminotransaminase levels.
Tofacitinib in Combination With Nonbiologic Disease-Modifying Antirheumatic Drugs in Patients With Active Rheumatoid Arthritis: A Randomized Trial, Joel Kremer, MD; Zhan-Guo Li, MD, PhD; Stephen Hall, MD; Roy Fleischmann, MD; Mark Genovese, MD; Emilio Martin-Mola, MD, PhD; John D. Isaacs, PhD; David Gruben, PhD; Gene Wallenstein, PhD; Sriram Krishnaswami, PhD; Samuel H. Zwillich, MD; Tamas Koncz, MD; Richard Riese, MD, PhD; and John Bradley, MD, Ann Intern Med. 2013;159(4):253-261. doi:10.7326/0003-4819-159-4-201308200-00006