ACR/ARHP Annual Meeting 2013
Patients with rheumatoid arthritis and diabetes mellitus had no increase in mean fasting blood glucose levels after 3 months of treatment with tofacitinib, a novel oral Janus kinase inhibitor, according to a pooled analysis of five phase 3 trials reported at the 2013 ACR/ARHP Annual Meeting.
The supplemental New Drug Applications (sNDAs) contained data from Phase 3 trials involving patients with psoriatic arthritis, including safety analyses from the larger tofacitinib clinical development program.
Drugs in the Pipeline
Pfizer announced results from the OPT (Oral treatment Psoriasis Trial) Retreatment study (A3921111) assessing tofacitinib for the treatment of adults with moderate-to-severe chronic plaque psoriasis.
Pfizer announced top-line results from the OPAL Beyond study, the second Phase 3 trial of Xeljanz (tofacitinib citrate) for the potential treatment of patients with active psoriatic arthritis (PsA).
Researchers from the University of Calgary found moderate to high quality evidence that triple therapy with methotrexate + sulfasalazine + hydroxycholoroquine or combining methotrexate + most biologic disease-modifying antirheumatic drug (DMARDs) or tofacitinib demonstrated similar efficacy in controlling disease activity in methotrexate-naive patients or after an inadequate response to methotrexate.
Tofacitinib plus MTX was shown to be non-inferiority vs. adalimumab plus MTX, however, Xeljanz monotherapy did not meet its primary endpoint for non-inferiority vs.adalimumab plus MTX, or vs. Xeljanz plus MTX.
Xeljanz and Xeljanz XR are Janus kinase (JAK) inhibitors indicated to treat moderately to severely active rheumatoid arthritis when methotrexate therapy is inadequate.
Pfizer announced that the FDA has approved a sNDA to update the current label of Xeljanz (tofacitinib citrate) tablets to include radiographic data from two Phase 3 studies, ORAL Scan and ORAL Start.
Vaccination rates in patients with rheumatoid arthritis remain poor "despite the high rates of infectious disease-related morbidity and mortality," a review published in Clinical Opinion in Rheumatology has found.
ACR/ARHP 2018 Annual Meeting
Patients treated with JAK inhibitors for rheumatoid arthritis may be less likely to have low disease activity if they are obese compared with those who are overweight.