Positive, top-line results from the second Phase 3 Oral Psoriatic Arthritis Trial (OPAL) Beyond study of tofacitinib citrate (Xeljanz) were recently released. The study evaluated the efficacy and safety of tofacitinib citrate 5 mg and 10 mg twice daily (BID) in adults with active psoriatic arthritis (PsA) who had an inadequate response to at least 1 tumor necrosis factor inhibitor (TNFi). For the Phase 3, randomized, double-blind, placebo-controlled, 6-month study 395 participants were randomized to equally receive tofacitinib 5 mg BID, tofacitinib 10 mg BID and placebo. Participants in the study were required to be on one conventional synthetic disease modifying antirheumatic drug (csDMARD) as background therapy and continue that dose for the duration of the study.
The trial met its primary efficacy endpoints and demonstrated a statistically significant (P<0.0001) improvement with tofacitinib 5 mg BID and 10 mg BID compaed to placebo treatment as measured by American College of Rheumatology 20 (ACR20) response and Health Assessment Questionnaire Disability Index (HAQ-DI) score at 3 months. Overall safety findings in the study were consistent with previous tofacitinib studies.
Positive, top-line results from the second Phase 3 Oral Psoriatic Arthritis Trial (OPAL) Beyond study of tofacitinib citrate (Xeljanz) were recently released. The study evaluated the efficacy and safety of tofacitinib citrate 5 mg and 10 mg twice daily (BID) in adults with active psoriatic arthritis (PsA) who had an inadequate response to at least 1 tumor necrosis factor inhibitor (TNFi). For the Phase 3, randomized, double-blind, placebo-controlled, 6-month study 395 participants were randomized to equally receive tofacitinib 5 mg BID, tofacitinib 10 mg BID and placebo. Participants in the study were required to be on one conventional synthetic disease modifying antirheumatic drug (csDMARD) as background therapy and continue that dose for the duration of the study.
The trial met its primary efficacy endpoints and demonstrated a statistically significant (P<0.0001) improvement with tofacitinib 5 mg BID and 10 mg BID compaed to placebo treatment as measured by American College of Rheumatology 20 (ACR20) response and Health Assessment Questionnaire Disability Index (HAQ-DI) score at 3 months. Overall safety findings in the study were consistent with previous tofacitinib studies.
Positive, top-line results from the second Phase 3 Oral Psoriatic Arthritis Trial (OPAL) Beyond study of tofacitinib citrate (Xeljanz) were recently released. The study evaluated the efficacy and safety of tofacitinib citrate 5 mg and 10 mg twice daily (BID) in adults with active psoriatic arthritis (PsA) who had an inadequate response to at least 1 tumor necrosis factor inhibitor (TNFi). For the Phase 3, randomized, double-blind, placebo-controlled, 6-month study 395 participants were randomized to equally receive tofacitinib 5 mg BID, tofacitinib 10 mg BID and placebo. Participants in the study were required to be on one conventional synthetic disease modifying antirheumatic drug (csDMARD) as background therapy and continue that dose for the duration of the study.
The trial met its primary efficacy endpoints and demonstrated a statistically significant (P<0.0001) improvement with tofacitinib 5 mg BID and 10 mg BID compaed to placebo treatment as measured by American College of Rheumatology 20 (ACR20) response and Health Assessment Questionnaire Disability Index (HAQ-DI) score at 3 months. Overall safety findings in the study were consistent with previous tofacitinib studies.
