After Clinical Trial, Baricitinib Approved for Emergency Use

Baricitinib, a drug that pre-pandemic was largely used to help with rheumatoid arthritis, has been approved by the FDA for emergency use in treating COVID-19 patients. 

Good news for everyone, of course, but also particularly for Stanford. 

Our division of Hospital Medicine has been active in the adaptive COVID treatment trials from the beginning (ACTT-2 in this case for baricitinib) that led to this breakthrough.

The Evolution of a Trial

The ACTT-2 trial was the second phase of an adaptive NIH/ NIAID study, which started with ACTT-1 in March at various sites around the country, including Stanford hospital.  An adaptive study, as division chief of hospital medicine Neera Ahuja, MD, explains, means that “it will continue and build off of itself until the pandemic is over.”  It also meant a remarkably speedy beginning and a continued flexibility as one phase ended and the next began.

“The trials have evolved with very high quality from collaboration of all the team members on the slide as well as the Stanford IRB, SCCR, SHC research pharmacists and research nurses,” Ahuja recalls.  The Stanford ACTT team includes a large number of people, including team leaders like Ahuja, Kari Nadeau, MD, PhD, Naddisy Foundation Endowed Professor of Medicine and Pediatrics, David Svec, MD, MBA, clinical associate professor of medicine, Nidhi Rohtagi, MD, MS, clinical associate professor of medicine, Evelyn Ling, MD, clinical assistant professor of medicine, Minjoung Go, MD, clinical assistant professor of medicine, Jeff Chi, MD, clinical associate professor of medicine, Rita Pandya, MD, clinical assistant professor of medicine, and Andre Kumar, MD, MEd, clinical assistant professor of medicine, as well as a number of staff members.

The ACTT-1 trial, the first phase, “identified remdesivir as effective for the treatment of moderate to severe Covid and led to FDA approval of remdesivir as the standard of care,” Ahuja explains. The ACTT-2 trial then studied baricitinib and its effectiveness in combination with remdesivir. Trial participants were given remdesivir and then randomized to either placebo or baricitinib.  The trial’s importance led to an influx of patients from other institutions, with hospitals aiming to get their COVID patients access to both remdesivir and clinical trials. 

Emergency Use

Baricitinib is a JAK (Janus Kinase) inhibitor that has that has anti-inflammatory properties (interfering with the cytokine storm seen in moderate to severe COVID infections) and may also have antiviral effects. It’s an oral pill that was given to some trial participants with the intravenous remdesivir, and showed statistically significant results.  Baricitinib, Ahuja explains, “showed an improvement in the clinical condition of hospitalized COVID patients who were on oxygen but not mechanically ventilated.”

The wider implications of these findings are highly promising too: “It may help prevent patients who are hospitalized with COVID from becoming more severely ill,” Ahuja says. “We may then see fewer patients being transferred to the ICU and fewer patients being intubated.”

An emergency use approval by the FDA emphasizes urgency, and that’s how quickly baricitinib will be implemented.

The adaptive trial hasn’t finished, either—Ahuja and her colleagues have already finished ACTT-3, which tests interferon-beta, with results still being analyzed.  ACTT-4 will study baricitinib versus dexamethasone.  And there are other COVID studies on the way as well.

Baricitinib is just one example of many that point to an exhaustive search for treatment and care for COVID patients.  Ahuja, for one, isn’t resting on her laurels.  “We need to aggressively continue with our clinical trials until we have an effective vaccine or a definitive treatment, and hopefully both.”

A Victory for Hospital Medicine

But this promising development means a great deal, nationally, globally, and as a triumph for the division of Hospital Medicine.  Ahuja explains that Hospital Medicine has been taking care of the majority of the COVID patients in the hospital, and almost all of COVID patients are first admitted to the medical wards, staffed by the division’s hospitalists.  (Up to 20% of the admitted COVID patients may also make a detour to the ICU.)  They’ve seen the pandemic unfold in real time, raced against the clock to administer trials, and now they get to bring their results to the bedside.

As Ahuja states, “It’s inspiring to study the patients we are caring for and then apply these results back to our patients."