An update on Tofacitinib effectiveness in combination with traditional DMARDs in rheumatoid arthritis
Tofacitinib is an oral medicine of class Janus kinase (JAK) inhibitors used for the treatment of rheumatoid arthritis (RA). JAKs are known to be the proteins that help in controlling biological processes like blood formation and the immune response responsible for causing pain, tenderness and swelling or inflammation. Stem cells of bones and joints contain JAKs. Inflammation and tissue destruction linked with the RA can be prevented by the inhibition of JAKs.
Recently, a study has been conducted in which a group of investigators have compared patient-reported outcomes (PROs) in subjects with RA treated with tofacitinib or placebo in combination with traditional disease-modifying antirheumatic drugs (DMARDs).
It was a 12-month study with 795 patients with active RA and previous inadequate response to therapy with ≥ 1 conventional or biologic DMARD were randomized (4:4:1:1) to tofacitinib 5 mg BID, tofacitinib 10 mg BID, placebo advanced to 5 mg BID, or placebo to 10 mg BID, in combination with stable background DMARD therapy. Patient Global Assessment of Arthritis (PtGA), Patient Assessment of Arthritis Pain (Pain), physical function (Health Assessment Questionnaire-Disability Index [HAQ-DI]), health-related quality of life (Short Form-36 [SF-36]), fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue [FACIT-F]), and sleep (Medical Outcomes Study Sleep [MOS Sleep]) were the main PROs.
There was considerable improvement at 3rd month from baseline versus placebo in PtGA, Pain, HAQ-DI, all eight SF-36 domains, FACIT-F, and MOS Sleep with tofacitinib 10 mg BID, and in PtGA, Pain, HAQ-DI, seven SF-36 domains, FACIT-F, and MOS Sleep with tofacitinib 5 mg BID. There was continuous improvement till 12th month. Patients reported considerably more improvement and minimum clinically important differences at 3rd month versus placebo in all PROs.
The results are indicative of a great combination therapy as patients with active RA when treated with tofacitinib combined with background conventional DMARD therapy achieved more sustained, significant, and clinically meaningful improvements in PROs as compared to placebo.