The efficacy and safety of XELJANZ® (tofacitinib) were tested in 2 studies that involved 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 treated with different medications. 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
• 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

XELJANZ may cause serious side effects. Learn more about the Most Important Risk Information you should know about XELJANZ.

XELJANZ Provided Relief Of Joint Pain And Swelling In As Early As 2 Weeks. For Some, It Took 3 To 6 Months. Individual Results May Vary.^*

The OPAL Broaden Study

OPAL Broaden was a 1-year 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 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. No patients took placebo after month 3 in the study.

The most common adverse drug reactions reported during the first 3 months in psoriatic arthritis controlled clinical trials and occurring in ≥2% of patients treated with XELJANZ include the following: upper respiratory tract infection, nasopharyngitis, diarrhea, and headache. Learn more about the Most Important Risk Information you should know about XELJANZ.

^*Results were seen for patients taking XELJANZ in combination with a nonbiologic DMARD.

^†All patients on XELJANZ or placebo also took a nonbiologic DMARD, such as methotrexate.

XELJANZ Provided Relief Of Joint Pain And Swelling In As Early As 2 Weeks. For Some, It Took 3 To 6 Months. Individual Results May Vary.^*

Key Facts From The OPAL Broaden Study

OPAL Broaden was a 1-year 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.^†

Rapid Joint Relief

• XELJANZ reduced joint pain and swelling in as early as 2 weeks. For some, it took 3 to 6 months. Individual results may vary.
• In the study, OPAL Broaden, half of the patients taking XELJANZ experienced less joint pain and swelling at 3 months. Individual results may vary.

Lasting Joint Relief

• At 1 year, 68% of patients taking XELJANZ experienced less joint pain and swelling. Individual results may vary.

XELJANZ may cause serious side effects. Learn more about the Most Important Risk Information you should know about XELJANZ.

^*Results were seen for patients taking XELJANZ in combination with a nonbiologic DMARD.

^†All patients on XELJANZ or placebo also took a nonbiologic DMARD, such as methotrexate.

XELJANZ Provided Relief Of Joint Pain And Swelling In As Early As 2 Weeks. For Some, It Took 3 To 6 Months. Individual Results May Vary.^*

The OPAL Beyond Study

OPAL Beyond was a 6-month 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 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. No patients took placebo after month 3 of the study.

The most common adverse drug reactions reported during the first 3 months in psoriatic arthritis controlled clinical trials and occurring in ≥2% of patients treated with XELJANZ include the following: upper respiratory tract infection, nasopharyngitis, diarrhea, and headache. Learn more about the Most Important Risk Information you should know about XELJANZ.

^*Results were seen for patients taking XELJANZ in combination with a nonbiologic DMARD.

^†All patients on XELJANZ or placebo also took a nonbiologic DMARD, such as methotrexate.

XELJANZ Provided Relief Of Joint Pain And Swelling In As Early As 2 Weeks. For Some, It Took 3 To 6 Months. Individual Results May Vary.^*

Key Facts From The OPAL Beyond Study

OPAL Beyond was a 6-month 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, XELJANZ helped reduce inflammation where ligaments and tendons insert into bone (enthesitis).^‡
• At 3 months, XELJANZ helped reduce inflammation of fingers or toes (dactylitis).^‡

XELJANZ may cause serious side effects. Learn more about the Most Important Risk Information you should know about XELJANZ.

^*Results were seen for patients taking XELJANZ in combination with a nonbiologic DMARD.

^†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.