Data Published in New England Journal of Medicine Shows Pfizer’s Tofacitinib Meets Primary Endpoint in Brazilian Study in Patients Hospitalized with COVID-19 Pneumonia

Pfizer Inc. (NYSE: PFE) and The Academic Research Organization (ARO) from the Hospital Israelita Albert Einstein today announced that the New England Journal of Medicine has published positive findings from the STOP-COVID study (NCT04469114) evaluating the efficacy and safety of oral Janus kinase (JAK) inhibitor tofacitinib in 289 hospitalized adult patients with COVID-19 pneumonia who were not on ventilation.

The trial was a research collaboration between Pfizer and the ARO from the Hospital Israelita Albert Einstein in Sao Paulo, Brazil, which was the trial coordinating center. It is important to note that tofacitinib has not been approved or authorized for use by any regulatory authority worldwide for the treatment of COVID-19 and tofacitinib should not be used in patients with an active serious infection.

The trial demonstrated a lower cumulative incidence of death or respiratory failure through day 28 - the primary outcome of the study - with tofacitinib (18.1%) compared to placebo (29.0%) (risk ratio 0.63; 95% confidence interval [CI], 0.41 to 0.97; p=0.04). Death from any cause through day 28 occurred in 2.8% of patients in the tofacitinib group and in 5.5% in the placebo group (hazard ratio 0.49; 95% CI, 0.15 to 1.63).

Serious adverse events occurred in 20 patients (14.1%) in the tofacitinib group and 17 (12.0%) in the placebo group. Among protocol-specified adverse events of special interest, deep vein thrombosis, acute myocardial infarction, ventricular tachycardia, and myocarditis occurred in one patient each in the tofacitinib group; hemorrhagic stroke and cardiogenic shock occurred in one patient each in the placebo group. The incidence of serious infection was 3.5% in the tofacitinib group and 4.2% in the placebo group.

"We are encouraged by the initial findings of our randomized trial of tofacitinib in patients hospitalized with COVID-19 pneumonia. These results provide new information which indicates that the use of tofacitinib when added to standard of care, which includes glucocorticoids, may further reduce the risk of death or respiratory failure in this patient population," said Otavio Berwanger, M.D., Ph.D., Director of the Academic Research Organization, Hospital Israelita Albert Einstein. "The study builds on the hypothesis that JAK inhibition could mitigate systemic and alveolar inflammation in patients with COVID-19-related pneumonia."

"To effectively combat the COVID-19 pandemic, there remains a critical need for multiple therapeutic options to treat patients who have contracted the virus," said Tamas Koncz, M.D., Ph.D., Chief Medical Officer, Pfizer Inflammation & Immunology. "As outlined in Pfizer's five-point plan at the onset of the COVID-19 pandemic, we are keenly focused on working across the healthcare ecosystem with partners like Hospital Israelita Albert Einstein. We look forward to our continued collaboration as we analyze the full dataset from this study and assess next steps."

The multi-center, randomized, double-blind, placebo-controlled trial included adult patients hospitalized with COVID-19 pneumonia receiving standard of care. Patients were randomized in a 1:1 ratio to receive either tofacitinib 10 mg twice daily plus standard of care or placebo twice daily plus standard of care for up to 14 days or until hospital discharge. Overall, 89.3% used glucocorticoids during hospitalization, predominantly dexamethasone.

About XELJANZ® (tofacitinib)

XELJANZ® (tofacitinib) isapproved in the U.S. in four indications: adults with moderately to severely active rheumatoid arthritis (RA) after methotrexate failure, adults with active psoriatic arthritis (PsA) after disease modifying antirheumatic drug (DMARD) failure, adults with moderately to severely active ulcerative colitis (UC) after tumor necrosis factor inhibitor (TNFi) failure and patients 2 years of age or older with active polyarticular course juvenile idiopathic arthritis (pcJIA). See Limitations of Use below.

XELJANZ has been studied in more than 50 clinical trials worldwide, including more than 20 trials in RA patients, and prescribed to over 300,000 adult patients (the majority of whom were RA patients) worldwide since 2012.i,ii,iii As the developer of tofacitinib, Pfizer is committed to advancing the science of JAK inhibition and enhancing understanding of tofacitinib through robust clinical development programs in the treatment of immune-mediated inflammatory conditions.

Pfizer recently communicated an increased rate of major adverse cardiovascular events (MACE) and malignancies (excluding non-melanoma skin cancer (NMSC)) for XELJANZ relative to anti-TNF therapy in RA patients who were 50 years of age or older and had at least one additional cardiovascular (CV) risk factor. Pfizer is continuing to work with the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and other regulatory agencies to review the full results and analysis.