One Patient's Positive Perspectives

12th Benlysta Infusion

This week I received my 12th Benlysta infusion, and am glad to report moderate success with it as a contributor to controlling my lupus.   While I had keenly anticipated it might be as miraculous as the Rituxan (Rituximab) infusions I received several years ago, it has fallen far short of that hope.  However, the drug I received during the phase three clinical trials of Rituximab proved to have remarkable effectiveness for some lupus patients, but treatment with it presented grave danger for others.

While I entered a five-year dramatic near remission of my lupus after receiving just two infusions of Rituximab, a few unfortunate patients in the clinical trials lost their lives to a fatal brain infections.  A normally harmless common childhood virus was re-awakened in some of the clinical trial patients, causing their untimely deaths.  The number of these deaths was compared to the total number of patients in the trial, and it was clear the fatalities were too many to be a coincidence.

Benefits v. Risks

Benefits of effective drugs may not outweigh the risks

The Rituximab deaths demonstrated that lupus patients seemed to have too much risk to take the drug, and the excitement about Rituximab as a treatment for lupus cooled off quickly.  The FDA did not approve it and many insurance companies will not pay for Rituximab to treat Lupus.  Although Rituximab is FDA approved and widely used with outstanding results for rheumatoid arthritis, certain cancers and many other auto-immune diseases, Rituximab proved much too risky for lupus patients.  The potential benefits of Rituximab for Lupus clearly did not outweigh the great risks.

I also thank God for many answered prayers and His gracious protection through the clinical trial, and that I was spared from developing a horrible infection.  I am thankful for the many people who prayed for me during the time I was receiving Rituximab* infusions, knowing there were possible great risks, and even a remote possibility of death.  Although I was more concerned about a possible allergic reaction, there was an even greater risk from infection revealed during the trial.

So, I now continue to take Belimumab infusions, and do enjoy its moderate help with controlling my lupus. Still,  I cannot help but wonder how I might feel right now if Rituximab had been safer, and if it were still available to me.  One of the important issues patients must realize when they take part in clinical trials, is that, although they may feel great in response to new drugs being investigated, the medication being studied may not continue to be available.  If access to drugs taken in a clinical trial stops and they are not approved by the FDA, then participants must be ready to accept a return to using less effective drugs and a possible return to more active lupus.

safe “okay” is better that dangerous miracles

“Okay” with safe drugs is better than dangerous miracles

For me there is some clear amount of disappointment to cope with after having received both Rituximab and Belimumab infusions.  But, still I am very thankful for the five years of dramatically improved health that I enjoyed after Rituximab.  I am also very thankful to for the slower, but clearly modest improvement of my lupus after ten months of Belimumab infusions.

Although after almost one year of Belimumab I hoped to feel absolutely wonderful, instead have to describe how I feel today as just “okay.”  Okay is better than where I was  a year ago, and that is still very important progress in treating my lupus.  It is not miraculous, like Rituximab seemed to me, but it gives acceptable improvement.  I’ll take it and thank God daily for the ability to receive this helpful and safer FDA-approved treatment.

opportunity to make a difference

Participation in clinical trials makes a difference

It is also very important to me to know that my participation in a clinical trial contributed to the greater process of helping find new drugs that are safe and effective for treating lupus.  Even though the drug I took did not ultimately become a help to future lupus patients, the clinical trial helped in other ways.  If not for patients like me, being willing to put their hopes and health at some level of risk, new drugs would never be found for lupus.

The safest trials to take part in are phase three clinical trials, when medicines are tested that have already proven effective in phase one and phase two trials.  The phase three trials help verify appropriate doses, and measure how effective the drugs are in treating a specific disease.  Phase 3 trials help doctors know 1) how much medicine to give, 2) how often to give it, and 3) how well the medicine works. Progress in finding these new drugs would never be reached without patients and their doctors being willing to participate in the lupus adventure and risks of joining a clinical trial.  I am still grateful for that opportunity to make a difference.

*[Errata:  The incorrect word "Benlysta" was deleted and correct word "Rituximab" was inserted after publishing.]

Other posts about Rituxan and Benlysta:

Lupus Rituxan treatment denied by insurance company
Pending FDA approval of new lupus drug Benlysta

Lupus, and Benlysta in my future…

Benlysta Infusions for Lupus – Day One

Benlysta infusions for lupus – Day 15

Benlysta Infusions for Lupus – Day 30

Benlysta Infusions for Lupus – Day 60

Benlysta Infusions for Lupus – Day 90 – Thanksgiving

Lupus and Benlysta after 21 weeks

Lupus post-infusion infection, steroids and the E.B. effect

Benlysta & Rituxan infusions for Lupus: the tortoise and the hare

Lupus and Benlysta – 25 Weeks and Infusion #8

Lupus, Benlysta infusions and almost glorious mornings

Lupus and postponing a Benlysta infusion

Lupus, singing and a visiting hummingbird

Lupus and Benlysta after 7 months – Infusion #9

Benlysta infusion #10 while pondering the good, the bad and the ugly of lupus
Diagnosis and Treatment of Lupus: Fact #12 – Lupus requires multiple medicines!

Prognosis and Hope: Lupus Fact #28 – Normal life span expected with current treatment standards

Prognosis and Hope: Lupus Fact #31 – Lupus research lengthens lives!

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Comments on: "Lupus and Benlysta – after 10 months & infusion #12" (2)

  1. ” Even though the drug I took did not ultimately become a help to future lupus patients, the clinical trial helped in other ways. If not for patients like me, being willing to put their hopes and health at some level of risk, new drugs would never be found for lupus.”

    Lupus adventurer, oh that I were that selfless that I could enter a clinical trial and risk my health so that others may benefit! I know I’m not selfish, but I’m battling Shrinking Lung Syndrome from lupus. I’m not going to enter a clinical trial for a drug that may or MAY or MAY NOT work, when the one that I just started has been PROVEN to work.

    If it’s found that the study medication isn’t working, my lungs would likely have shrunk more with TLC down well below it’s current 78%, and my ability to breath compromised further; why? The answer sounds so selfish; because I wanted to further research?

    I know only too well the consequences of sustained difficulty breathing (all systems are affected, especially the heart). God bless you for your choice and I hope the maintenance medication continues to help. Annie

    • Annie: Thank you so much for sharing about your situation and bringing out this very, very important point!

      Your situation demonstrates why because of the life-threatening nature of lupus that it is so hard for clinical trials to be completed. You are in exactly the same situation as most lupus patients with organ damaging lupus, and should not feel bad about your wisdom to not put yourself at risk in a clinical trial.

      I would only have the courage to consider a clinical trial for a drug that is in the PHASE 3 level trials, when they already are sure it has tested safe in earlier trials, and they want to fine tune more information about dosage and effectiveness. I am way too “chicken” and UN-adventurous to do phase one or two trials!! Maybe only if there was absolutely no other option left…

      The danger with Rituxan for lupus patients was a surprise result in the phase 3 trials, because it already had a relatively long history with certain cancers and had FDA approval for rheumatoid arthritis. No one expected that outcome!

      The only reason I even joined in the Rituxan clinical trial in the first place was that everything else available to me had failed; and lupus was still going after my brain and liver. I had failed all the customary treatments, including chemo, transplant drugs, steroids, etc. The clinical trial of Rituxan was the only thing left for me to do at that time. It was a last resort, not so much courage as desperation for me and my doctor. Fortunately, it was a godsend and effective for me and turned my lupus around.

      Usually, doctors are understandably reluctant to send their patients to clinical trials unless normal treatments fail. This is what slows down the progress on new drugs, but it makes sense. Benefits still have to outweigh risks. Even though I knew there was might be a very small risk of death from infusion reactions, the risk of my brain and liver attack and uncontrolled lupus was greater.

      I wasn’t really that courageous, just at a dead end with only one option open. Thanks for speaking up!! LA :-)

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