Findings Presented During 11th European Academy of Dermatology and Venereology Spring Symposium in Belgrade, Serbia
NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE:PFE) announced today detailed results from the Oral treatment Psoriasis Trial (OPT) Retreatment study (A3921111), a Phase 3 study investigating tofacitinib for the treatment of adult patients with moderate-to-severe chronic plaque psoriasis. This three-period study showed that tofacitinib, as a 5 mg or 10 mg pill taken twice daily, met its two primary efficacy endpoints. The safety profile of tofacitinib in OPT Retreatment was consistent with previous studies and there were no new safety findings in this trial.
The first primary endpoint of OPT Retreatment evaluated the maintenance of clinical response in patients who remained on tofacitinib after an initial treatment phase compared to 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 treatment with tofacitinib. Throughout the study, the efficacy response was measured by the proportion of subjects achieving a Physician’s Global Assessment (PGA) response of “clear” or “almost clear” skin and the proportion of subjects achieving at least a 75% reduction in the Psoriasis Area and Severity Index (PASI75), two commonly used measures of efficacy in psoriasis.
“Psoriasis is a chronic disease that affects approximately two-to-three percent of people worldwide, and there are times when patients with psoriasis may need to stop and restart therapy for medical or non-medical reasons, such as elective surgery or receipt of live immunizations,” said lead investigator Robert Bissonnette, M.D., Innovaderm Research, Montreal, QC, Canada. “The OPT Retreatment data showed that patients who stayed on therapy with tofacitinib maintained their rates of response and for those who stopped therapy, a proportion of patients were able to regain their original clinical response when retreated with tofacitinib.”
Tofacitinib, an oral Janus kinase (JAK) inhibitor, is part of a new class of medicines in development for the treatment of moderate-to-severe plaque psoriasis. Top-line results from OPT Retreatment were previously announced in October 2013, and the detailed results of this study were shown today in an oral presentation during the 11th European Academy of Dermatology and Venereology (EADV) Spring Symposium in Belgrade, Serbia.
OPT Retreatment was a Phase 3 randomized, double-blind, three-period, parallel group, placebo-controlled 56-week study. This study evaluated the efficacy and safety of the withdrawal and retreatment with tofacitinib 5 mg and 10 mg twice daily compared to placebo in 674 adult patients with moderate-to-severe chronic plaque psoriasis. During the first period (24 weeks), which was a secondary endpoint of this study, patients were treated with either tofacitinib at a dose of 5 mg or 10 mg twice daily in a blinded manner. During this initial 24 weeks of treatment:
The patients who achieved a PASI75 and PGA response were then randomized to either continue tofacitinib or switch to placebo for 16 weeks or until they lost half of their original PASI response to treatment, whichever occurred first. During this withdrawal period:
In the retreatment period, all patients resumed their original tofacitinib dose until week 56. After 16 weeks of restarting therapy with tofacitinib, the efficacy response was evaluated in the proportion of patients who lost half of their original PASI or PGA response during the withdrawal phase and showed that:
The most common adverse events for all study periods were nasopharyngitis and upper respiratory tract infection. There was one cardiac-related death that occurred during the OPT Retreatment study at the 5 mg dose. However, in the opinion of the investigator, there was not a reasonable possibility that this death was related to tofacitinib.
OPT Retreatment is one of five studies from the Phase 3 OPT Clinical Trial Program, one of the largest global clinical trial programs in moderate-to-severe chronic plaque psoriasis to date. The results from this study will be included in the planned tofacitinib psoriasis submission package to regulatory authorities in various markets. Pfizer currently intends to submit a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for the approval of tofacitinib for the treatment of adults with moderate-to-severe chronic plaque psoriasis by early 2015.
About the OPT Clinical Trial Program
The Phase 3 OPT clinical trial program consists of five studies (including one long-term extension study) evaluating oral tofacitinib 5 mg and 10 mg twice daily in adults with moderate-to-severe chronic plaque psoriasis. It is a global, comprehensive clinical development program that includes over 3,600 patients in 36 countries, and is one of the largest global clinical trial programs in moderate-to-severe chronic plaque psoriasis to date. In addition to the OPT Retreatment study, the OPT Program includes the following Phase 3 studies of tofacitinib in adults with moderate-to-severe plaque psoriasis:
About Plaque Psoriasis
Psoriasis is a chronic, immune-mediated disease, affecting primarily the skin but also other organs, such as nails and joints. It affects approximately two-to-three percent of people worldwide and 7.4 million people in the United States.1,2,3,4,5,6,7 Due to inconsistent response to treatment, adverse effects, and the limited persistence of therapeutic effects of some therapies, a need for additional therapies for patients with moderate-to-severe chronic plaque psoriasis remains.8,9,10 According to recent published surveys, approximately 50 percent of patients with psoriasis are dissatisfied with their treatment and under-treatment represents a significant problem. Even though guidelines typically state that moderate-to-severe patients are candidates for systemic therapy – e.g., medicines given by mouth or an injection - many adult plaque psoriasis patients appear to be undertreated. Approximately 30 percent of treated moderate patients and 22 percent of treated severe patients receive only topical therapies like ointments and creams in the U.S.11
XELJANZ® (tofacitinib citrate) 5 mg Tablets RA U.S. Label Information
Tofacitinib is currently approved in more than 20 countries around the world for the treatment of moderate-to-severe rheumatoid arthritis. In the U.S., the brand name for tofacitinib is XELJANZ® (ZEL’ JANS’), and it is approved at the 5 mg dose for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate.
XELJANZ is a prescription medicine called a Janus kinase (JAK) inhibitor. XELJANZ is used to treat adults with moderately to severely active rheumatoid arthritis in which methotrexate did not work well.
Important Safety Information
It is not known if XELJANZ will harm an unborn baby. To monitor the outcomes of pregnant women exposed to XELJANZ, a registry has been established. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves by calling 1-877-311-8972.
Please click the direct link to the full prescribing information for XELJANZ, including boxed warning and Medication Guide: http://labeling.pfizer.com/ShowLabeling.aspx?id=959.
Pfizer Inc.: Working together for a healthier world®
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. To learn more, please visit us at www.pfizer.com.
DISCLOSURE NOTICE: The information contained in this release is as of May 23, 2014. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information about tofacitinib, including its potential benefits and the anticipated submission of applications with regulatory authorities, that involves substantial risks and uncertainties. Such risks and uncertainties include, among other things, the uncertainties inherent in research and development, including, without limitation, the ability to meet anticipated clinical trial completion dates as well as the possibility of unfavorable clinical trial results; whether an sNDA will be submitted in the U.S. by early 2015, and whether and when any applications may be submitted with regulatory authorities in various other jurisdictions, for tofacitinib for the treatment of moderate-to-severe chronic plaque psoriasis; whether and when the FDA and regulatory authorities in other jurisdictions may approve any such applications, as well as their decisions regarding labeling and other matters that could affect its availability or commercial potential; and competitive developments.
A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2013 and in its subsequent reports on Form 10-Q and Form 8-K.
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Source: Pfizer Inc.