Tofacitinib Effective in Phase 3 Psoriasis Retreatment Study
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. Results showed that tofacitinib 5mg or 10mg twice daily met its 2 primary efficacy endpoints.
The OPT Retreatment Study was a Phase 3, randomized, double-blind, three-period, parallel group, placebo-controlled 56-week study (n=674) that studied the efficacy and safety of the withdrawal and retreatment with tofacitinib vs. placebo.
The first primary endpoint evaluated the maintenance of clinical response in patients who remained on tofacitinib after an initial treatment phase vs. patients who were switched to placebo (withdrawal phase). The second primary endpoint examined patients who lost half of their original clinical response during the withdrawal phase, and measured the proportion of these patients who regained their original clinical response after restarting with tofacitinib.
During the initial 24 weeks of treatment, 44% and 68% of patients who received tofacitinib 5mg and 10mg twice daily achieved at least a 75% reduction in the Psoriasis Area and Severity Index (PASI75), respectively. Also, 42% and 63% of patients who received tofacitinib 5mg and 10mg twice daily achieved a PGA response of “clear” or “almost clear” skin, respectively.
During the withdrawal period, none of the patients experienced psoriasis rebound. In the retreatment period, 36.8% and 61.0% of patients who received tofacitinib 5mg and 10mg twice daily, respectively, achieved a PASI75; and 44.8% and 57.1% of patients who received tofacitinib 5mg and 10mg twice daily, respectively, achieved a PGA of “clear” or “almost clear” skin.
Xeljanz (tofacitinib), an oral Janus kinase (JAK) inhibitor, is already approved for moderately-to-severely active rheumatoid arthritis with inadequate response or intolerance to methotrexate.
For more information call (800) 438-1985 or visit Pfizer.com.