Questions & Answers for March 2015

The drug HUMIRA has been advertised on TV as a successful treatment for psoriasis, rheumatoid arthritis and Crohn’s disease. Is this a new wonder drug?

Adalimumab (HUMIRA) is a top-selling drug[1] approved by the Food and Drug Administration (FDA) for treatment of an impressive list of diseases, including rheumatoid arthritis, Crohn’s disease, ulcerative colitis and psoriasis.[2] These conditions all involve problems with the immune system and, for that reason, are sometimes called autoimmune disorders.[3] Adalimumab works by suppressing the immune system, blocking a chemical that normally triggers excessive inflammation found in autoimmune diseases.[4]

Is adalimumab a wonder drug? It is certainly effective for treating psoriasis, rheumatoid arthritis and Crohn’s disease, and for other FDA-approved uses. But along with those benefits comes an equally impressive list of harms. First, by suppressing the immune system, the drug makes it harder to fight life-threatening infections. It also may increase the risk of cancer and may cause heart failure, severe allergic reactions and nervous system disease.[5] Scientists still do not quite understand how adalimumab works, and it strangely seems to cause additional immune system disorders in some patients, leading to rare cases of symptoms that resemble systemic lupus erythematosus (SLE or lupus).[6]

Given its potentially serious risks, adalimumab should be given only for its FDA-approved uses, and patients with mild forms of the diseases for which it is indicated should avoid taking this drug.[7]

You said not to take rivaroxaban (XARELTO), but my cardiologist claims that if I stop taking it, I’ll have a stroke. What should I do?

Your doctor is right to be concerned about a stroke if you stop taking rivaroxaban.

We have advised patients not to start using the anticoagulants (blood thinners) rivaroxaban, dabigatran (PRADAXA) and apixaban (ELIQUIS). These drugs do not represent a clear breakthrough over the existing treatment, warfarin (COUMADIN, JANTOVEN), and it is still too early to adequately understand their risks.

But if you are already on one of the new anticoagulants, our advice is different. Discontinuing rivaroxaban, dabigatran or apixaban for atrial fibrillation increases your risk of blood clots. Transitioning onto another anticoagulant when you stop taking any of these drugs may help reduce, but not necessarily eliminate, these risks. We advise that if you are already on rivaroxaban or dabigatran, you continue treatment unless your doctor advises you to stop for another reason.

References

[1] King S. The best selling drugs of all time; Humira joins the elite. Forbes. January 28, 2013. http://www.forbes.com/sites/simonking/2013/01/28/the-best-selling-drugs-of-all-time-humira-joins-the-elite/

[2] HUMIRA drug label. http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125057s367lbl.pdf

[3] American Autoimmune Related Diseases Association. List of diseases. http://www.aarda.org/autoimmune-information/list-of-diseases/.

[4] HUMIRA drug label. http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125057s367lbl.pdf

[5] Ibid.

[6] Ibid.

[7] Ibid.