CLL connection with taking Embrel or Humira

[Winsey]

I took both of these drugs , not at the same time, prior to my diagnosis in 2014.My oncologist told me there could be a connection, and not to take either of them again. Anybody else have a problem with these drugs?

Thanks, Winsey

[AussieNeil Administrator]

You are fortunate to have a specialist alert to potential risks. I presume your oncologist has noted the FDA report on the possible risk of developing leukaemia (including CLL) from taking Humira: fda.gov/Drugs/DrugSafety/Po...

Some extracts with my emphasis:

Information for Healthcare Professionals: Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, Cimzia, and Simponi)

FDA ALERT [8/4/2009]:

FDA is requiring the manufacturers of TNF blockers to update the Boxed Warning in the prescribing information to alert healthcare professionals of an increased risk of lymphoma and other malignancies in children and adolescents treated with TNF blockers.

and lower down -

Information for Patients

Be aware that taking TNF blockers may increase the risk of developing lymphoma, leukemia, and other cancers.

and lower down -

Data Summary: Leukemia

FDA reviewed 147 post-marketing reports of leukemia in all patients, including adults, using TNF blockers. Of the 147 cases, acute myeloid leukemia (44 cases), chronic lymphocytic leukemia (31 cases), and chronic myeloid leukemia (23 cases) were the most frequently classified types of leukemia reported. Four pediatric cases of leukemia were reported in the review. Most patients (61%) were also receiving other immunosuppressive therapies. There were a total of 30 deaths reported. In 26 of the 30 deaths, the cause was reported to be leukemia, and the event was associated with the use of TNF blockers. The average time to onset of leukemia was within the first 1 to 2 years of therapy.

The interpretation of these findings is complicated by the fact that published epidemiological studies suggest that patients with rheumatoid arthritis may be at increased risk of leukemia, independent of any treatment with TNF blockers. However, based on the available data, FDA concludes there is a possible association between treatment with TNF blockers and the development of leukemia in all patients treated with these drugs. The current prescribing information for TNF blockers contains a warning for malignancies, but does not specifically mention leukemia. Therefore, to alert healthcare professionals to this possible association, FDA is requiring the incorporation of information on post-marketing reports of leukemia into the prescribing information for TNF blockers.

Note that the warning is not for adults. Of related concern is that CLL suppresses your immune system, which these drugs also do, so you would be at increased risk of infection while taking either of these drugs. Ultimately, you face a difficult decision on what you can most easily live with if you again feel the need for the benefits provided by these drugs. However, if you get to the stage of needing treatment for your CLL, you will likely find that the symptoms treated by these drugs will also subside. (Note that I'm not medically qualified.)

Neil

[MsLockYourPosts Passed Volunteer]

I have not had experience with either drug, but have seen several AML patients (I follow posts for a cousin) post that they feel that one of these drugs might have been the trigger for their AML. As Neil said, you are fortunate to have a doctor who pays attention to details.

[Rose_fancier in reply to MsLockYourPosts]

I was diagnosed with CLL in July 2017. I had just started Humira approximately 6 weeks prior. In addition, I took low dose Methotrexate for 10+ years.

Methotrexate also carries warnings for increased cancer risk, although the risk is much lower when administered in a low dose.

The first two Humira shots went very well. I felt great. It was amazing! However, after the third shot I developed greater fatigue than I had ever experienced from my autoimmune condition before. I also had bruises popping up in places where I knew I hadn’t had an injury.

I was due for quarterly blood work and that is how the out of range, abnormal lymphocyte cells were discovered. The CLL diagnosis came one month later.

I am currently on watch and wait. My oncologist says I may never need treatment.

I most likely had CLL without symptoms prior to starting Humira, as my absolute lymphocyte count had been slightly elevated since January 2017. Results from earlier tests, done through a different health care provider, were not available for me to review. I may have had elevated absolute lymphocyte numbers back even further.

Methotrexate was more likely the catalyst for my CLL than the Humira. However, I can’t help but wonder if

in some way the Humira interacted with the CLL to activate symptoms.

I willingly used the Methotrexate and Humira treatments, with full knowledge there was a small risk for developing cancer. I just figured It wouldn’t be me.

I find it interesting your oncologist advised you not to continue with Humira or similar TNF blockers. Mine gave me the go ahead to go back on Humira. My rheumatologist has told me I need the TNF blocker to control my autoimmune issues, although he was surprised the oncologist gave the OK to proceed.

Due to two upcoming knee replacement surgeries, I have put off the decision to start Humira until I have fully recovered from them.

In the mean time, l just can’t mentally get past my prior experience with Humira. It also doesn’t make sense to me to go back on a drug that will make it even harder for my immune system to fight the CLL. Hearing your oncologist’s advice makes me even more wary of trying Humira again.

I think your oncologist has the right perspective on this issue.

[Winsey in reply to Rose_fancier]

Than you for your reply.

[pkguk2 Partner CLL Support Association]

Hi Winsey. Neil's reply, as always, is comprehensive. Just to add to that information, the following is from The American College of Rheumatology:

"

The most significant side effect is an increased risk for all types of infections, including tuberculosis (TB) and fungal infections. Some of these infections may be severe. Patients should be tested for TB before starting therapy, because a hepatitis B infection can worsen during treatment. The usual way of testing is with a skin test, but a blood test is also available.

Long-term use of TNF inhibitors may increase the risk of cancers such as lymphoma and skin cancer. There are rare neurologic complications as well.. People who have a history of multiple sclerosis should not use them. People with significant heart failure should not use a TNF inhibitor, because their heart disease could worsen."

Very good that you have an oncologist who is alert to all of this.

Take care and good luck

[Winsey]

Many thanks, best to you as well.

[garrick66]

I took Humira for 10 years for psoriasis and was dx in 2015 with CLL at 51. My dr. was pretty sure there was a connection with the drug Humira. In his mind there was a clear connection but he also said there was no way to know for sure. In my mind because the Humira was suppressing my immune system that made me much more vulnerable, so I was the 1 in 100,000 people they mention in all the commercials who ended up with cancer. When I started taking the drug there was no cancer warning, had there been I might have thought more about it, but then again most drugs have some serious warnings and you never think your going to be the one, so you roll the dice trying to solve whatever is ailing you. When I was diagnosed in 2015 I immediately stopped taking the drug and found by changing my diet I was able to control my psoriasis. Looking back I wish I would have tried that route before taking such a nasty drug. Good luck to you.

[Winsey in reply to garrick66]

Thanks for your insight about psoriasis. I also have psoriasis, but take Otezla 30mg now. My psoriasis is much better, and I see my oncologist every 4 months to check blood levels, so far, it's wait & watch. Best of luck to you as well.