ing Xeljanz 5 mg twice daily in combination with a nonbiologic DMARD, compared to those receiving placebo.
In OPAL Broaden, 50% of patients taking tofacitinib 5 mg twice daily achieved an ACR20 response, compared to 33% of patients taking placebo (P ≤ .05), at 3 months. In OPAL Beyond, 50% of patients achieved an ACR20 response with tofacitinib 5 mg twice daily, compared to 24% of patients taking placebo (P ≤ .05), at 3 months.
In both studies, statistically significant improvements in ACR20 response were also seen with tofacitinib compared to placebo at 2 weeks, a secondary endpoint (OPAL Broaden: 22% and 6% [P = .0003], respectively; OPAL Beyond: 27% and 13% [P = .0046], respectively).
The safety profile of tofacitinib observed in patients with PsA was consistent with the safety profile observed in rheumatoid arthritis patients. The most common adverse events (>3% of patients) were nasopharyngitis, upper respiratory tract infection, headache, and diarrhea.
The tofacitinib label cautions that patients treated with the drug are at increased risk of developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants, such as methotrexate or corticosteroids. If a serious infection develops, tofacitinib should be interrupted until the infection is controlled. Full prescribing information is available online.
"As a practicing rheumatologist, I've seen the significant physical impact psoriatic arthritis has on people living with the disease, and many patients are looking for additional therapeutic options," OPAL study investigator Philip Mease, MD, from the Swedish Medical Center, University of Washington, Seattle, said in the company release. "I'm pleased that Xeljanz is now available for use in the treatment of this chronic condition."
"Psoriatic arthritis is a serious and debilitating chronic illness that should be diagnosed and treated early," Randy Beranek, president and CEO, National Psoriasis Foundation, said in the release. "As an organization that advocates for people living with psoriatic arthritis, we welcome the availability of new therapies for treating this disease."
Xeljanz(Tofacitinib)
XELJANZ Rx
Generic Name and Formulations:
Tofacitinib 5mg; tabs.
Company:
Pfizer Inc.
Indications for XELJANZ:
Moderately-to-severely active rheumatoid arthritis (RA) in adults who have had an inadequate response or intolerance to methotrexate (MTX), as monotherapy or in combination with MTX or other nonbiologic disease-modifying anti-rheumatic drugs (DMARDs). Active psoriatic arthritis in adults who have had an inadequate response or intolerance to MTX or other DMARDs, in combination with nonbiologic DMARDs.
Adult:
5mg twice daily. Switching from immediate-rel to XR tabs: start XR tabs the day following the last immediate-rel 5mg dose. Moderate-to-severe renal impairment or moderate hepatic impairment; concomitant potent CYP3A4 inhibitors, or drugs that result in both moderate CYP3A4 and potent CYP2C19 inhibition: 5mg once daily. Concomitant potent CYP3A4 inducers: not recommended. Dose adjustments: see full labeling.
Children:
Not established.
Warnings/Precautions:
Increased risk of serious or fatal infections (eg, TB, bacterial, viral, invasive fungal, or other opportunistic pathogens). Avoid in active, serious, or localized infections. Chr |
