Clinical Trials

Clinical Trials

The efficacy and safety of XELJANZ^® (tofacitinib) were tested in 2 studies that included adult patients with active psoriatic arthritis. The studies included patients who were new to biologic disease-modifying antirheumatic drugs (DMARDs) as well as patients who hadn’t found enough symptom relief with a biologic DMARD. In each study, participants were divided randomly into groups, and 238 participants were treated with XELJANZ 5 mg twice daily, in addition to a nonbiologic DMARD, such as methotrexate. They did not know which treatment they were receiving, and some took a sugar pill (placebo).

Patients in the clinical trials had active psoriatic arthritis for at least 6 months and had:

• At least 3 tender/painful joints
• At least 3 swollen joints
• Skin lesions associated with active plaque psoriasis

In these studies, 238 adult patients took 5 mg of XELJANZ twice a day in addition to a nonbiologic DMARD, such as methotrexate. Both studies measured if XELJANZ:

• Reduced joint pain and swelling
• Improved the ability to accomplish certain daily activities. Improvement in physical function was measured by the Health Assessment Questionnaire Disability Index (HAQ-DI), which assesses the ability to complete different activities, such as dressing and grooming, arising, eating, walking, hygiene, reaching and gripping.
• Reduced inflammation of the fingers or toes (dactylitis)
• Lowered the number of affected areas with enthesitis, inflammation that happens where tendons and ligaments insert into bone

Common side effects of XELJANZ in psoriatic arthritis patients include upper respiratory tract infections (common cold, sinus infections), headache, diarrhea, nasal congestion, sore throat, runny nose (nasopharyngitis), high blood pressure (hypertension), and acne. Learn more about the Most Important Information you should know about XELJANZ.

The OPAL Broaden Study

OPAL Broaden was a study that included adult patients with active psoriatic arthritis who didn’t get enough symptom relief with a DMARD, like methotrexate. In this study, patients took either XELJANZ^* or a placebo.^* At 3 months, patients who received placebo were switched over to XELJANZ.

• At 2 weeks, 22% of patients taking XELJANZ (24 out of 107) versus 6% taking placebo (6 out of 105) had improvement in their psoriatic arthritis signs and symptoms, as measured by the ACR20 response criteria.
• At 3 months, 50% of patients taking XELJANZ (54 out of 107) versus 33% taking placebo (35 out of 105) had less joint swelling and tenderness, as measured by ACR20.
• At 1 year, 68% of patients taking XELJANZ (73 out of 107) had less joint swelling and tenderness, as measured by ACR20.

Results Of The Study

^*All patients on XELJANZ or placebo also took a nonbiologic DMARD, such as methotrexate.
^†Results were seen for patients taking XELJANZ in combination with a nonbiologic DMARD.

Common side effects of XELJANZ in psoriatic arthritis patients include upper respiratory tract infections (common cold, sinus infections), headache, diarrhea, nasal congestion, sore throat, runny nose (nasopharyngitis), high blood pressure (hypertension), and acne. Learn more about the Most Important Information you should know about XELJANZ.

The OPAL Beyond Study

OPAL Beyond was a study that included adult patients with active psoriatic arthritis who didn’t get enough symptom relief with at least 1 tumor necrosis factor (TNF) blocker, such as Humira^® (adalimumab). In this study, patients took either XELJANZ^* or a placebo.^* At 3 months, patients who received placebo were switched over to XELJANZ.

• At 2 weeks, 27% of patients taking XELJANZ (35 out of 131) versus 13% taking placebo (17 out of 131) had improvement in their psoriatic arthritis signs and symptoms, as measured by the ACR20 response criteria.
• At 3 months, 50% of patients taking XELJANZ (65 out of 131) versus 24% taking placebo (31 out of 131) had less joint swelling and tenderness, as measured by ACR20.
• At 6 months, 60% of patients taking XELJANZ (78 out of 131) had less joint swelling and tenderness, as measured by ACR20.

Results Of The Study

^*All patients on XELJANZ or placebo also took a nonbiologic DMARD, such as methotrexate.
^‡Results were seen for patients taking XELJANZ in combination with a nonbiologic DMARD. These results were for patients who began the study with the symptom.

Common side effects of XELJANZ in psoriatic arthritis patients include upper respiratory tract infections (common cold, sinus infections), headache, diarrhea, nasal congestion, sore throat, runny nose (nasopharyngitis), high blood pressure (hypertension), and acne. Learn more about the Most Important Information you should know about XELJANZ.