Kim A Papp1, James G Krueger2, Steven R Feldman3, Richard G Langley4, Diamant Thaci5, Hideshi Torii6, Stephen Tyring7, Robert Wolk8, Annie Gardner9, Charles Mebus8, Huaming Tan8, Yingchun Luo8, Pankaj Gupta8, Lotus Mallbris10, Svitlana Tatulych11. 1. Probity Medical Research and K. Papp Clinical Research Inc, Waterloo, Ontario, Canada. 2. Rockefeller University, New York, New York. 3. Wake Forest Baptist Health, Winston-Salem, North Carolina. 4. Dalhousie University, Halifax, Nova Scotia, Canada. 5. Comprehensive Center for Inflammation Research, University Hospital Schleswig-Holstein Campus Lübeck, Lübeck, Germany. 6. Division of Dermatology, Tokyo Yamate Medical Center, Tokyo, Japan. 7. Department of Dermatology, University of Texas Medical School, Houston, Texas. 8. Pfizer Inc, Groton, Connecticut. 9. Pfizer Inc, Cambridge, Massachusetts. 10. Dermatology Unit, Department of Medicine Solna, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden. 11. Pfizer Inc, Groton, Connecticut. Electronic address: svitlana.tatulych@pfizer.com.
Abstract
BACKGROUND:Tofacitinib is an oral Janus kinase inhibitor being investigated for psoriasis. OBJECTIVES: We sought to report longer-term tofacitinibefficacy and safety in patients with moderate to severe psoriasis. METHODS: Data from 2 identical phase-III studies, Oral-treatment Psoriasis Trial Pivotal 1 and 2, were pooled with data from these patients in an ongoing open-label long-term extension study. Patients (n = 1861) were randomized 2:2:1 to tofacitinib 5 mg, 10 mg, or placebo twice daily (BID). At week 16, placebo patients were rerandomized to tofacitinib. Pivotal study participants could enroll into the long-term extension where they received tofacitinib at 10 mg BID for 3 months, after which dosing could be 5 or 10 mg BID. RESULTS: At week 28, the proportions of patients randomized to tofacitinib 5 and 10 mg BID achieving 75% or greater reduction in Psoriasis Area and Severity Index score from baseline were 55.6% and 68.8%, and achieving Physician Global Assessment of clear or almost clear were 54.7% and 65.9%. Efficacy was maintained in most patients through 24 months. Serious adverse events and discontinuations because of adverse events were reported in less than 11% of patients over 33 months of tofacitinib exposure. LIMITATIONS: There was no dose comparison beyond week 52. CONCLUSIONS:Oral tofacitinib demonstrated sustained efficacy in patients with psoriasis through 2 years, with 10 mg BID providing greater efficacy than 5 mg BID. No unexpected safety findings were observed.
RCT Entities:
BACKGROUND:Tofacitinib is an oral Janus kinase inhibitor being investigated for psoriasis. OBJECTIVES: We sought to report longer-term tofacitinib efficacy and safety in patients with moderate to severe psoriasis. METHODS: Data from 2 identical phase-III studies, Oral-treatment Psoriasis Trial Pivotal 1 and 2, were pooled with data from these patients in an ongoing open-label long-term extension study. Patients (n = 1861) were randomized 2:2:1 to tofacitinib 5 mg, 10 mg, or placebo twice daily (BID). At week 16, placebo patients were rerandomized to tofacitinib. Pivotal study participants could enroll into the long-term extension where they received tofacitinib at 10 mg BID for 3 months, after which dosing could be 5 or 10 mg BID. RESULTS: At week 28, the proportions of patients randomized to tofacitinib 5 and 10 mg BID achieving 75% or greater reduction in Psoriasis Area and Severity Index score from baseline were 55.6% and 68.8%, and achieving Physician Global Assessment of clear or almost clear were 54.7% and 65.9%. Efficacy was maintained in most patients through 24 months. Serious adverse events and discontinuations because of adverse events were reported in less than 11% of patients over 33 months of tofacitinib exposure. LIMITATIONS: There was no dose comparison beyond week 52. CONCLUSIONS: Oral tofacitinib demonstrated sustained efficacy in patients with psoriasis through 2 years, with 10 mg BID providing greater efficacy than 5 mg BID. No unexpected safety findings were observed.
Authors: Heike C Hawerkamp; Alina Domdey; Lisa Radau; Philipp Sewerin; Péter Oláh; Bernhard Homey; Stephan Meller Journal: Arthritis Res Ther Date: 2021-05-21 Impact factor: 5.156