Kaitlyn D’Onofrio

DocwireNews

Roche&rsquo;s <a href="https://www.docwirenews.com/docwire-pick/rheumatology-picks/are-arthritis-drugs-the-holy-grail-of-the-covid-19-pandemic-trials-rush-to-find-solutions/">arthritis drug</a> tocilizumab failed to meet the primary and secondary endpoints in COVACTA, a randomized, phase 3 trial of COVID-19 patients hospitalized with pneumonia, the company announced.The results of the COVACTA trial follow those of an Italian trial of tocilizumab&mdash;marketed as Actemra/RoActemra&mdash;that found no difference between tocilizumab versus placebo in intensive care requirements or mortality.Despite the results of the <a href="https://www.docwirenews.com/docwire-pick/rheumatology-picks/roches-tocilizumab-does-not-improve-covid-19-pneumonia-more-research-underway/">Italian trial</a>, Roche moved ahead with its own COVACTA study.The COVACTA trial randomized hospitalized <a href="https://www.docwirenews.com/docwire-pick/rheumatology-picks/rheum-round-up-covid-19-edition-arthritis-drug-trials-rheumatic-disease-and-covid-19/">COVID-19 patients</a> with associated pneumonia to receive standard of care plus either intravenous tocilizumab or placebo. The primary outcome was improved clinical status, measured using a seven-category ordinal scale to assess clinical status per intensive care needs and/or ventilator use and supplemental oxygen needs, over a four-week period. Secondary outcomes included four-week mortality.<a href="https://clinicaltrials.gov/ct2/show/NCT04320615">COVACTA enrolled 450 patients</a>. Differences in the primary outcome were not statistically significant between the tocilizumab versus placebo groups (odds ratio [OR], 1.19; 95% confidence interval [CI], 0.81 to 1.76; P=0.36). At week four, mortality rates did not largely differ between the treatment versus placebo groups (19.7% vs. 19.4%; difference, 0.3%; 95% CI, -7.6% to 8.2%; P=0.9410). The difference in median number of ventilator-free days between the tocilizumab versus placebo groups did not reach statistical significance (22 days vs. 16.5 days; difference, 5.5 days; 95% CI, -2.8 to 13.0 days; P=0.3202). Four-week infection rates were 38.3% in the tocilizumab group and 40.6% in the placebo group, and serious infection rates were 21.0% and 25.9%, respectively. No new safety signals were observed for tocilizumab.Although COVACTA&rsquo;s primary endpoint was not met, the tocilizumab group had a shorter median time to hospital discharge or &ldquo;ready to discharge&rdquo; than the placebo group (20 days [95% CI, 17.0 to 27.0 days] vs. 28 days [95% CI, 20.0 to NE days]; P=0.0370). But because the main endpoint was not achieved, the difference could not be considered to have met statistical significance.&ldquo;People around the world are waiting for further effective treatment options for COVID-19 and we are disappointed that COVACTA did not demonstrate a benefit for patients in either clinical status or mortality at week four. We will continue to generate evidence to provide a more complete understanding of Actemra/RoActemra in COVID-19 associated pneumonia,&rdquo; Levi Garraway, MD, PhD, chief medical officer and head of global product development at Roche, <a href="https://www.roche.com/media/releases/med-cor-2020-07-29.htm">said in a press release</a>.&ldquo;We are grateful for the patients and physicians around the world who helped us to complete this study quickly during a public health crisis, while upholding the highest standards of scientific rigour. We will keep working to help combat the COVID-19 pandemic.&rdquo;

Brandon Twyford

DESTINY-Breast09 Demonstrates First-Line Superiority of Enhertu Plus Pertuzumab in HER2-Positive Metastatic Breast Cancer

HER2 Breast Cancer

Trodelvy Plus Keytruda Significantly Improves Progression-Free Survival in PD-L1+ mTNBC, Phase III Data Show

Triple-Negative Breast Cancer

Jordana Jampel

Actress Michelle Trachtenberg's Premature Death From Diabetes Reveals Dangers of Chronic Complications

Diabetes

Latest News

Tocilizumab Flops in Late-Stage Trial for COVID-19–Related Pneumonia

COVID-19

Roche’s arthritis drug tocilizumab failed to meet the primary and secondary endpoints in COVACTA, a randomized, phase 3 trial of COVID-19 patients hospitalized with ...

About Us

Editorial Policy

Advertising

Contact Us

eNewsletters

Contribute

Career Center

MashupMD

Blood Cancers Today

Cancer Nursing Today

GU Oncology Now

Urban Health Today

Bile Duct Cancer

Colorectal Cancer

Gastroesophageal Cancer

Gastric Cancer

GEP-NETs

GIST

Liver Cancer

Pancreatic Cancer

GI Oncology Now

Anemia

Deep Vein Thrombosis

Essential Thrombocythemia

Hemophilia

Immune Thrombocytopenic Purpura

Myelodysplastic Syndromes

Myelofibrosis

Myeloproliferative Neoplasms

Polycythemia Vera

Pulmonary Embolism

Sickle Cell Disease

Thrombocytopenia

Thrombophilia

Thrombosis

Thrombotic Thrombocytopenic Purpura

Venous Thromboembolism

von Willebrand Disease

Heme Today

Acute Kidney Injury

ADPKD

Anemia and Kidney Disease

Chronic Kidney Disease

COVID-19 and Kidney Disease

Diabetes and Hypertension

End-Stage Renal Disease

Gout

Hyperkalemia

IgAN

Kidney Transplantation

Metabolic Acidosis

Nephrology Times

HR Breast Cancer

Genetics & Breast Cancer

Breast Cancers Today

Atherosclerotic Disease

Atrial Fibrillation

Heart Failure

Hypertension

Interventional Cardiology

Lipid Management

Practice Tips With Dr. Lichaa

Preventive Cardiology

Stroke

Cardiology

Breast Cancer

Gynecologic Cancer

Head and Neck Cancer

Skin Cancer

Oncology

Sleep

Urology

Ophthalmology

— Demodex Blepharitis

Neurology

Rheumatology

Gastroenterology

Pulmonology

Infectious Diseases

— HIV

Health and Wellness

Lupus

Future of Medicine

Orthopedics

Pharmacology

Career News

More

Conferences

CardioNerds

The Sleep Source With Dr. Morse

Rheumatology Rounds With Dr. Maheswaranathan

Partners

Expert Interviews

Subscribe