Baricitinib Better for Rheumatoid Arthritis than Humira

Baricitinib Better for Rheumatoid Arthritis than Humira

By Staff

The New England Journal of Medicine published supplementary data, which show that people with moderate-to-severe rheumatoid arthritis (RA) who took the oral Janus kinase inhibitor baricitinib had better outcomes through 52 weeks compared to adalimumab (Humira).

“This is an exciting time for rheumatology, with potential new treatments for rheumatoid arthritis on the horizon. The RA-BEAM study of baricitinib is the first phase 3 trial showing that a once-daily, oral treatment significantly improved clinical outcomes compared with a current standard of care, injectable adalimumab used with background methotrexate therapy,” said Peter Taylor, M.A., Ph.D., F.R.C.P., study author and Norman Collisson chair of Musculoskeletal Sciences in the Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences at the University of Oxford.

In the RA-BEAM study, researchers studies more than 1,300 people who did not have an adequate response to methotrexate, but continued the use of methotrexate throughout the duration of the study.  Participants were randomized to placebo once daily (n=488), baricitinib 4 mg once daily (n=487) or adalimumab 40 mg biweekly (n=330).  At the 24th week, participants taking placebo crossed over to the baricitinib treatment group. The design of the head-to-head study and statistical analysis plan included prespecified and controlled for multiple testing for both non-inferiority and superiority of baricitinib compared with adalimumab.

A higher proportion of participants taking baricitinib achieved ACR50 and ACR70 response – composite scores that represent at least 50 percent and 70 percent improvement, respectively, in multiple components of RA disease activity – compared to adalimumab.  This was observed as early as week 8 and continued through week 52.

These improvements were statistically significant compared to adalimumab at weeks 12, 20, 28, 32 and 40. At week 52, both ACR50 and ACR70 rates were higher in the baricitinib group compared to adalimumab, although only ACR50 was statistically significant.

Serious adverse events were observed in 8% for baricitinib and 4% for Adalimumab. Major adverse cardiovascular events (MACE) were reported in less than 1% of patients in both the baricitinib and adalimumab groups (baseline through 52 weeks). A total of 5 deaths were reported in the study (1 placebo, 2 baricitinib, 1 adalimumab and 1 placebo rescued to baricitinib).

“These data demonstrate that baricitinib could provide another treatment option for people with rheumatoid arthritis,” Taylor added.

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Having psoriatic spondylitis I can tell you that there are those of us that have either failed a couple of these so called biologic drugs that seem way more costlier than necessary and now we have been scrutinized for pain management. I have been told by my rheumatologist that my condition is one of the most painfully chronic conditions to have and yet I get “scrutinized” by pain management doctors because I’m not a cancer patient nor am I eighty years old. There is something very much not right in this country of ours where the CDC aka our government would allow for such strong devastating guidelines that will affect many legitimate pain patients before they come out with adequate less scrutinizing drugs. I will venture to say that they’re going to have a lot more suicides on their hands by means other than opioids if they don’t do something about this situation quickly. And secondly when is it that the CDC knows more about what’s best for our doctors patients than they do?

Ben Aiken Longfellow

My son was diagnosed with psoriatic arthritis about 10 years ago. He is now 36 years old. He was diagnosed with a rare kidney disease when he was nine years old. I thank the Creator for blessing us with 2 boys. My son is active, responsible, and has a beautiful family now. He does take Humira and all I can read and understand about the medication does make me very uneasy. My son states that the “help” from the medication outweighs the dangers at this point in his life. He is intelligent and knows with his physicians help, what is “best” for him. Unfortunately I and about 11 million other non cancer chronic pain patients have had decided what is “best” for us with our chronic pain. Reduction in opioid dosage “across the board”. As per the CDC “guideline” introduced about a year ago without the knowledge of 100’s of millions of people. I admit that I am under informed. Who else could have known about the “guideline” except those that were in the reasoning behind the “guideline”. The CDC stated that only about 5,000 and some people bothered to address the “guideline” hearing before it was introduced. Maybe we did not know about it without he “heads up” from our physicians. Maybe they…..did not know about it?.I for one would have surely spoke up if I had known the true misguide effort to to “help” those who used opioid medication for the control of their unwanted, unwarranted, continuous pain. I feel like my son at this point. I know, with the help of my pain specialist of over 5 years what is “helping” me with my severe chronic pain and what may be harmful to me. After all, I am only examined every 2 months in his office. Checked for opioid toxicity. Examined for “normal” continues movement and for any sign of further damage due to the surgeries. Advised of any new treatment or procedure that may help me in my day to day life. Is that not the responsibility of my pain specialist. He also asks, ” are you OK” with your pain? I REALLY appreciate that. I do NOT take advantage of my physician. I have been on the same medication, same dosage for over 5 years. He is very concerned about the CDC “guideline” and the misguided effect it is having on his patients. I will not be surprised if he just stops treating chronic pain patients altogether. I would not consider it “patient abandonment”. I would call it a conscience. If he can not really help his patients, he is not going to watch them suffer any worse. I will hold other agencies responsible for patient abandonment.

Tim Mason

Copy and paste the link above in your browser for complete details on the FDA’s report and clinical information. Page 196 and 197 are interesting.

Jean Price

At first glance, this seems like hopeful information on a promising drug! However there are some important considerations to at least keep in mind! One downside of taking new medications like the oral biological medications for RA is undoubtedly the COSTS, (it would be great if this article gave that information, too). It matters little how well a drug works if it’s priced beyond what the average person can pay out of pocket for! For instance, on a part D Medicare plan, giving yourself injections of one of these types of medication can start out costing around $100 a month… yet skyrocket to over $600, even end up over $1000 a month when the person hits the infamous coverage gap, or doughnut hole….where most people actually do spend more time per year than in either the first stage or the catastrophic stage! However, if a patient goes to the doctor’s office for an IV infusion, (of the exact same medication), it can then be billed through Medicare A and B, at little to NO cost to the patient, especailly if they happen to have a Medicare supplement plan. (The ACTUAL cost billed to Medicare then is usually several thousands dollars!!) Comparison studies, like this phase 3 clinical trial, can benefit patients….YET ARE ALSO DESIGNED TO BENEFIT THE pharmaceutical COMPANIES—who can then market the medication as being preferred, due to BETTER PATIENT RESPONSE, better results. Although the statistics on the improved reduction of symptoms for the newer medication here would definitely make it worthy of consideration, the statistics of serious side effects… actually DOUBLING by comparison…must be taken into consideration too…very seriously…and from each individual patient’s perspective…including their history and their severity of RA. Plus the patient’s comfort level in their physician’s awareness regarding those side effects would be important! A medication causing severe side effects needs to be discontinued as soon as possible!. Those numbers regarding the incident of serious side effects actually translate into 104 PEOPLE for the newer medication, versus 52 PEOPLE in the comparison group… out of a study total of 1300 PEOPLE!! When reviewing a study report, it can be all to easy to fail to remember these weren’t just numbers or statistics…but rather ACTUAL PEOPLE who had serious issues WHILE taking the medications! And this particular number seems very significant, to me! Especially when a person’s decisions must be based on the TYPE of side effect (something else I wish this article covered!)…..and how willing they are personally to to risk ANY side effects or adverse effects, regardless of the statistics. In truth, it matters little what the statistics show of experiencing a serious side effect or risk…when it happens TO YOU! This is good to keep in mind for ALL medications, treatments, surgeries, and other interventions. And it is, in fact, how we were instructed to explain potential side effects to patients who were signing up for medication studies! (Just a reminder here…we make good decisions when, first…we are “informed”, meaning we clearly know… Read more »