One Patient's Positive Perspectives

Posts tagged ‘Rituximab’

Lupus and General Health Facebook Chat – Hospital for Special Surgery

HSS Lupus and General Health Updated AnnoucementThis afternoon at work included an unusual break from other duties, by joining a one-hour Facebook chat “Lupus and General Health” that was hosted at 5:30 EST/2:30 PST by the Hospital for Special  Surgery (HHS), Molly’s Fund and the Lupus Foundation of America.  Questions were submitted through reader’s comments after the first HHS welcoming Facebook post, and each of the panel members wrote responsive comments to answer almost most of the questions that were submitted.

My question about Benlysta was answered by Peggy Crow from HHS:

Lupus Adventurer: How might extended Benlysta infusion therapy affect lupus biomarkers, such as ANA titer, etc.?

Peggy Crow: To Lupus Adventurer. That’s a really interesting question. In fact some of my research colleagues and I were just asking ourselves a related question today. When the clinical trials were performed, some biomarker and autoantibody data were tested, but not much. As I recall, some antibody levels decreased a bit, but not all of the antibody types. I doubt that the ANA would disappear. In any case, it’s a great question and one that deserves more research. Understanding effects of a drug on biomarkers can help us understand more about what is going on with the immune system in lupus

Lupus Adventurer:  I ask because my biomarkers are now quiet, after 20 years lupus treatment, with methotrexate, imuran, plaquenil plus clincial trial of Rituxan (amazing) and now almost 3 years of Benlysta. Previous ANA would be in the 1:1300 range, now 1:40. Symptoms are quite moderated again with Benlysta, but I am curious about the correlation between this medication and biomarker activity. Thanks!

Peggy Crow:  L.A. It is really great to hear that you are doing much better than in the past. What I would say about Benlysta and ANAs is that while I doubt that the Benlysta would directly reduce the antibodies enough to bring down the ANA titer as much as you describe, it is certainly possible that you have shown a good therapeutic response to Benlysta and the generally reduced disease activity is being reflected in the lower ANA titer. Benlysta works well in some but not all lupus patients. So it sounds like you are one of the fortunate responders.

Lupus Adventurer: This gives me something to think about and discuss with my doctor. Thank you so much for your response!

th24684V04Click on this Hospital for Special Surgery link to go to the HHS Facebook page and read the all the readers’ questions and the panel’s outstanding responses.  This was an excellent event with a knowledgeable panel and sponsors!

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Lupus Adventurer says goodbye to little canus lupus familiaris

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Sleepy little friend

Just about sixteen years ago, long before Benlysta, before Rituxan, and shortly before the beginning of Methotrexate and Imuran, little Rudy joined our household.  He was the result of the barter system.  My husband taught piano lessons to the two sons of a couple we knew who raised purebred miniature long-haired dachshunds.  After teaching enough lessons to equal the discounted price of a well-bred puppy, little Rudy became the newest addition to our home.

Lupus and a dachsund's perspective, I want to be like that!

Performing for a treat

Over many years of watching our children finish growing up, graduate from high school, get married and now our four grandchildren, Rudy has been there, friend to all who knew him, and companion to many.  When I spent months on strict bed rest with massive lupus flares and an unstable spine, he was a little puppy who curled up next to me, comforting me in my intense persistent pain.  We bonded, and I guess I became his surrogate people “mom.”  Any time I felt awful or was home sick with lupus woes or pains, there he would zoom, right to my side to curl up near and comfort me.

Each night as we arrived home, we saw his little head and ears flopping up and down through the window in the kitchen door, as he jumped straight in the air in excitement at our return.  His exuberance caused us to coin the expression, “jumping doggies” to explain many a gleeful moment.  His doggie cheerfulness had edged its way into our family conversations.

Lupus and a dachsund's perspective, I want to be like that!

Chewing on a ball

Yesterday, it was my last chance to comfort my little canine pal.  I spent some time yesterday morning with him, bathing my aging weak pup, gently brushing and grooming him and cleaning his kennel and bed.  As I left for work, he curled up in a fresh towel and snuggled down for a nap.  When my husband found him last night, he still was curled up just as I left him.  He seemed to have never moved or awakened from slumber, and my usual “have a good doggie day,” ended up my last goodbye to my little friend.

eyes closed and listening

Goodnight, Rudy…

Last night, he went to his final doggie resting place, wrapped in the same towel and snuggled into the warm spring soil, several feet below the turf of our backyard lawn.  We quietly planted him beneath his favorite spot in the yard, right where sunlight first warms the grass each morning.  So, with my husband holding a shovel and me holding a flashlight, in the darkness we quietly said goodbye to our faithful little family dog.

Goodnight, little Rudy, goodbye.

We are still learning about Benlysta

medical books and stethascope

Learning about Benlysta

Last week, one of the readers of Lupus Adventures commented about how her doctor still didn’t feel he knew enough about Benlysta to answer some of her questions about it.  (Thanks, Mary for sharing!)  He is not alone.

When I first told my rheumatologist that the first new drug in over fifty years JUST for lupus was approved, he still had not heard about it either.

Before taking Benlysta, I had Rituxan infusions in a clinical trial.  And before Rituxan, I had long before run out of standard medication options.

Many years ago, lupus attacked my liver after ten years of taking two steroid sparing mainstays of lupus treatment: a liver toxic cancer drug (methotrexate) and a transplant drug (azathiaprine) that is often used for rare cases of lupus liver involvement, like mine.  But, the drugs were not helping my liver one bit!   Both powerful drugs were stopped.  When I qualified for the Rituxan clinical trial, it had become my only real option left.

Nearly five years later, my lupus worsened over the first year I was dealing with the stress of relocating and overseeing the dementia care of my elderly father.

Without approval to restart Rituxan infusions, there was once again nothing left to take except the baseline lupus drugs plaquenil and prednisone.  These were never enough to control my lupus once organ involvement started.  It seemed my lupus was rapidly heading right back toward a miserable state of health like before Rituxan.  My lupus eventually worsened into major unbroken flare.

Dead End No Turns Left

Out of Options & Challenging My Faith

Out of Options, Again

Once, again, it seemed I was all out of options.  So, until Benlysta had FDA approval, we were still hoping, praying and waiting for over a year for another new option — while I became sicker and sicker.

This was a challenging time for my faith.

My family and loved ones saw me getting sicker and sicker, and my health faltered with increasing severity.  I was beginning to see disability and the end of my career approaching quickly in my not too distant future.  It seemed a major turning point was approaching while I going downhill fast.

I trusted that God would not give me more than I could handle, with His help.  Some days, it was still pretty rough.

Following the FDA with great interest.

claim denied

Appealing Claim Denials

After finally deciding it was time for more of the biologic drug that we knew worked so well for me,  we continued throughout 2010 appealing repeated insurance denials of Rituxan.

Meanwhile, especially because of my vested interest in finding a new option, I closely followed Benlysta’s progress through the FDA approval hearings.  Approval was unexpectedly stalled in November of 2010 due to misgivings about inconclusive findings in some patient groups with the highest and most severe lupus.  By this point, that frustrated me, too.

During the last few months Benlysta was considered for approval by the FDA, my doctor was still battling my insurance company for approval to resume Rituxan infusions.

Each time they said, “no” we appealed again!  We were relentless and didn’t give up hope until the insurance company’s medical director finally wrote a letter in January of 2011 to my doctor and me, telling us to just stop fighting their decisions.

“Quit appealing the appeals, we are simply not going to approve it,” was his final edict.  However, just a few weeks later there was an exciting new option available to us.

FDA Approved Stamp 2

FDA Approved!

Benlysta FDA approval for systemic lupus was secured in March of 2011.  This was the first new FDA approved drug for lupus in over 50 years!  A few weeks after its approval, I mentioned Benlysta to my doctor with hopeful expectation, and was somewhat surprised he didn’t yet know about this new biologic drug.

He listened as I explained, and promised to do his research before my next appointment.

Between the March approval and my next appointment early that summer, my doctor became very excited about what he had learned about Benlysta and was more than ready to have me start.  In fact, he started another one of his lupus patients on it, even before I spoke with him about it the second time.

Two years ago on August 24th, I began my first Benlysta treatments.  Although I have had to delay a couple of infusions due to travel and infections, I have stayed on course with my monthly infusions.

How does Benlysta work, then?

Benlysta wipes out vast numbers of the nasty little overpopulated Blys proteins that swarm around a patient’s B-Cells and confuse them.  Confused B-Cells apparently refuse to do their normal job, and instead pump out lupus antibodies.  Benlysta reduces the number of Blys proteins, and quiets down the confusion around the B-Cells.  The unconfused B-Cells resume functioning more normally, and stop making so many lupus antibodies.  See, http://www.nature.com/clpt/journal/v91/n1/images/clpt2011290f1.gif

Blys Mech BenlystaImm Path SLE

I like to imagine it as Benlysta intimidating my lupus to make it back quietly into a corner so my body can get busy cleaning up and repairing the rest of the battle-damaged tissues.

Benlysta has permitted my body to regain some ground it lost to cell damage caused by lupus antibodies.  It now has a better chance to repair the damaged connective tissue and organs.  I like to envision how Benlysta limits the number of enemy antibody “soldiers” getting through to the front lines to fight against me in my war against my lupus.

I saw myself finally starting to win the war.  After a while, I also started to feel noticeably stronger and healthier.

I am now so much better than before Benlysta!

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Better on Benlysta

My lupus, which had escalated after my Rituxan induced remission ended, is now quiet and very well moderated, again.  My organ damage has subsided, and only moderate symptoms prevail.

Yes, the big picture of Benlysta’s long-term effectiveness will show better over time, but there is no question it has already been a great help to many of us with lupus.

After six months, I was just starting to see the real benefits of its monthly reduction of the messenger Blys proteins responsible for bombarding and confusing my B-Cells .  For the first few months, my health continued to swung back and forth between either a little better or back to just as bad as it was before Benlysta.

At times in the beginning, I wondered if Benlysta would really do enough to merit the high costs to my self-insured employer.  It definitely took almost a year before the overall increased health benefits started to really kick in.  Eventually, I started to see the effect of being stronger and healthier physically due to lessened lupus activity.

When my body’s healing processes started gaining more ground, and lupus was not killing so many cells throughout my body on a daily basis, the next level of healing was starting to show.

Benlysta works differently than other lupus drugs.

benlysta gateway

Click Here to go to
Benlysta Gateway for More Information

I continued to get better during the second year.  Benlysta never did shout out and say, “wow, look at me I am a miracle drug” like Rituxan had done.  Benlysta didn’t zap my lupus into submission in just a handful of infusions. Benlysta doesn’t work the same way Rituxan does.

Although, Rituxan worked with almost miraculous speed and effectiveness on my lupus, it had a huge downside for some patients.  Unfortunately, Rituxan also caused a significant number of brain infection deaths in a handful of the hundreds of lupus patients who received it in the clinical trials.  I am grateful to have escaped the trouble  Rituxan brought to an unfortunate few lupus patients.

However, despite the after-the-fact knowledge of this potential risk, I am extremely glad for the five years of amazing near remission that I enjoyed, free of charge, thanks to the Rituxan Phase III clinical trials I participated in.

Now, we finally have a better, FDA option for lupus, Benlysta.  Not a cure, but a new effective lupus moderating drug.

Lupus and Benlysta Infusions – After 18 months

Infusion 1

18 Months of Benlysta

This afternoon marked the 18th month of Benlysta infusions for my Systemic Lupus.  In August, 2011, I started Benlysta infusions trying to control the rising level of my lupus activity.  A little over a year earlier, I had started coming out of a biologic drug induced five-year near remission.  Today, my lupus is well moderated and has quieted greatly.  Neither my doctor nor I am calling it remission, but “well-controlled” is an apt description of my lupus now.

During the year before  starting Benlysta, my CNS lupus, arthritis and other systemic symptoms had been on the constant rise, things were getting pretty rough, and my ability to continue working was threatened.  My symptoms and cognitive disruption from CNS involvement were worsening.  However, I had long before failed traditional chemotherapy drugs sometimes used for lupus.  My insurance had refused to pay for the biologic drug (Rituxan) that had previously put me into extended remission (the details about Rituxan appeals are best left for another discussion and are mentioned in other earlier posts.)

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Before Benlysta…

Two Years Before Benlysta

Two years before starting Benlysta, I had scheduled a trip to the San Francisco Bay Area to visit my dad.  This was the beginning of my journey out of remission and toward Benlysta.

My father had lived alone for almost a dozen years after the sudden passing of my mother.  He had managed pretty well on his own, with a few periodic check-ins and refresher courses from me to reinforce the month-long “Home Economics 101” training I put him through twelve years earlier.  For years he had managed to live a respectable widower’s existence, fulfilling his personal goal to keep the neighborhood widows at bay.   But, he knew something was wrong and resigned his post as treasurer of the local American Legion chapter because he was suddenly making math errors in his reports.

Sonoma

Sonoma, CA Wine Country

About this time, I had registered to attend a legal conference north of the Bay Area in the Sonoma wine country for two days of educational meetings.  I coordinated plans to spend several days before and after the conference visiting with my dad.  I was helping him make final plans to move to Arizona and put his house on the market, and he had seen a lawyer to set up my role as power-of-attorney for his affairs.  He had fallen a couple of times and he realized the wisdom of being nearer to family.  Little did we know at first that he would soon have the rapid onset of dementia overtaking him, and that the math errors and a couple of falls were just the beginning.

Just before I was supposed to leave for San Francisco, I called my dad about him picking me up at the subway vs. taking a cab to his house.  To my surprise, he seemed nearly catatonic when I spoke with him, drifting in and out of consciousness.  During his few lucid moments, I learned he had fallen again, and had since been sitting in his recliner for at least four days unable to get up.  He had not eaten nor drank anything, and from his description of his symptoms, I correctly deduced he was suffering confusion caused by kidney infection and failure.  He might not have survived had I not called him when I did.  One of my sisters was able to get to him immediately and she oversaw getting him to the hospital.

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Two months flying between AZ & CA…

Two Months of Travel

By the time I got to California, he had been hospitalized and was receiving life-saving treatment.   After a week of comprehensive care and testing he received a clear dementia diagnosis.  He would not be allowed to ever return to his home again, and would from then on need around-the-clock oversight and some ongoing nursing support.  He spent the next eight weeks in aggressive physical therapy, learning to help get himself in and out of a wheelchair while regaining enough strength to get around using a walker.  Only then I could put him on a plane to relocate to Arizona.

During those two months commuting between Phoenix and San Francisco I seemed to do fine, traveling back and forth every week to spend three or four days in Arizona alternating with three or four days in California.  I systematically cleaned out and packed up each room in my dad’s house, while meeting with realtors, estate sale shops, lawn care people and scores of doctors.  I also was forced to undergo a crash course in elder law, medicare, social security and pension benefits!

Flying back and forth took some toll on me, but buttressed by intercessory prayer from family and friends, my lupus seemed to stay quiet.  I secured an appropriate place in assisted living facility for dad near my Phoenix home, sold his house, and brought him back to Arizona with me in time for the holidays.

View from Infusion Room

View from Infusion Center

Weariness, Insurance Appeals & Giving Up

The next few months were very rocky and wearisome, as it soon became clear my father would need a higher level of care than assisted living.  After months of middle of the night calls from his caregivers, and 3:00 a.m. trips to his residence facility (because they were unable to quiet and calm his recurring agitation) I was wearing out.   Dad’s worsening dementia and my growing sleep deprivation and increased stress took a big toll on my health.  Although we eventually got him into a wonderful dementia/Alzheimer’s care facility perfect for his needs, and my horrible extended stress about dad’s situation was finally relieved, I paid a great physical price.

I was steadily moving out of the long stretch of remission I had enjoyed for so many years, and was rushing headlong into a major unabated lupus flare.

Surrender

Surrender

A year after my dad had been first hospitalized in California, my rheumatologist and I starting trying to get insurance approval for Rituxan again, since the clinical trial I had participated in years before had ended.  Before entering that trial years earlier, lupus began attacking my liver and I failed treatment with Methotrexate and with Imuran, a drug commonly used to treat lupus rare cases of lupus liver involvement.  Failure of standard treatments qualified me to take part in the phase three tests of Rituxan for lupus.

Now, in this new post-remission flare, plaquenil and steroids were all I could take for my worsening lupus.  Without Rituxan approval, my doctor and I were in a quandary.

Infusion Center Nurses

Infusion Center Nurses

What Next?  FDA Approval of Benlysta for Lupus!

I was seriously asking God what to do! Retire with hopes lupus would quiet down?  Go back to liver toxic chemotherapy drugs?

I didn’t have any answers for my worsening lupus, and for the second time in my life, I was at a place where I was considering a medical disability retirement.  I had once before narrowly skirted past this point after Rituxan turned my lupus around for so long.  Since my health insurance refused after several appeals to pay for Rituxan, my doctor and I had finally given up.

Infusion Center

Infusion Center

Within a few weeks of our “white flag,” Benlysta, the first new drug for lupus in over 50 years, was approved by the FDA for lupus in March 2011.  Everyone in the lupus community was in an uproar about the great news.

I was quietly hoping that I might be able to get approval for Benlysta, but after the failed year-long battle with underwriters and medical insurance directors over the earlier biologic drug, I was not confident it would be possible.  The published annual price for Benlysta was equal to the drug my insurance had adamantly denied to cover!

After a brief period of discussion with my doctor and an amazingly prompt insurance approval, a mere five months after giving up on Rituxan appeals, I was soon set to begin receiving Benlysta. Now, eighteen months into Benlysta treatments, my health is certainly not perfect – lupus is still there and my lupus neuropathy is somewhat troublesome – but, overall I am clearly healthier than before.

Lupus & Benlysta Now

Lupus & Benlysta Now

Lupus & Benlysta Now

My overall stamina and strength in are in a wonderfully better place, and I feel more resilient and energetic!  Thoughts of immediate medical disability retirement are now off the radar screen again, and I am continuing to plan for the rest of my professional future and a normal retirement in a few more years.

I am praising God for His unseen guidance through past events and issues I could not control, and for the unseen future ahead.

Benlysta seems to have no negative side effects except for a few days of extreme fatigue after most of my monthly infusions.  Extra care to prevent infections is always order, but over the past few months I have been exceptionally free of infectious diseases, somehow (by God’s grace!) avoiding strep, influenza and bronchitis, even when its seemed everyone else around me at home, work and church has been sick.  I have been both grateful and amazed!

Note:  If you are interested more information about my experience during the days, weeks and months after Benlysta treatments started, please feel free to check out my posts starting in August 2011 that explore that early part of my Benlysta journey toward better health and quieter lupus on my new Benlysta Journal page.

Lupus and Benlysta – One year rheumatologist check up with B+ Benlysta grade

One year of Benlysta

This month will mark one year since starting Benlysta infusions for my lupus.  As mentioned before, my lupus is thankfully now a milder, gentler “monster,” and my overall health has improved markedly.  Most importantly, my symptoms of central nervous system involvement and my energy levels have greatly improved.  Now, my cognitive function is much more stable, my short-term memory has vastly improved and my analytical and problem-solving mental processes are “back.”  I have really enjoyed overall improvement in my ability to complete mentally challenging essential functions of my job as a government law office administrator.  Benlysta helped me continue working.

The progress of lupus improvement from monthly Benlysta infusions was slow and moderate, but cumulative.  At the one-year milestone, looking back at the state of my health then compared to now, there is an unmistakable difference.  In the eighteen months before starting Benlysta, I had come of near remission and my overall condition was deteriorating steadily, and was again threatening my work.  After a few months on Benlysta my lupus quieted enough that recurring steroid bursts were not needed, and my daily maintenance steroid dose was cut in half.

Before Benlysta

Before Benlysta, my worsening lupus symptoms were many:

  • CNS lupus was extremely flared w/ increasing cognition, memory and analytical deficits
  • fatigue and malaise were overwhelming
  • joint pain and inflammation levels were high
  • gnawing “deep bone pain” in the long bones of my arms and legs
  • horribly itchy lupus rashes were out of control on my hands
  • mouth and nose ulcers were almost constant
  • malar butterfly rash, mostly showing up “peekaboo” more in the mornings and fading at night
  • sjogren’s syndrome was  very active in mouth and eyes
  • onset of intense peripheral neuropathy pain almost every night
  • insomnia due to neuropathy symptoms

Now, after one year of Benlysta infusions, my lupus complaints are fewer:

  • pesky, but much milder neuropathy pain several times each week
  • insomnia from neuropathy is much less frequent
  • arthritis inflammation in my hands running amok
  • a handful of random discoid lupus rashes come and go on my hairline, face, neck and arms

Benlysta gets B+ grade

So, the doctor is continuing my treatment with Benlysta infusions, and is very pleased with the improvement of my lupus.  Although we both originally hoped in vain for approval of Rituxan, because of my past dramatic improvement from using that biologic drug, that is old history.  Now, Benlysta has done a good job of quieting my lupus and improving my health.  If I were to rate Benlysta’s performance over the past year with a letter grade, it would definitely earn a B+ rating.  [Although Rituxan comparatively earned an A+, the insurance company would not pay for it.]  Benlysta’s B+ is an acceptable, welcome outcome!

Sulindac for inflammation

I am re-starting the anti-inflammatory prescription drug Sulindac for my arthritis inflammation.  This is my NSAID of choice, since I cannot take over-the-counter aspirin, motrin or naprosyn due to severe adverse reactions.  I took Sulindac successfully for most of 25 years, and it very effectively controlled ballooning hand knuckles.  For the first time in years, I was able to stop taking it completely for the five years following my Rituxan infusions.  It is time to start taking it, once again, since Benlysta is not effective controlling the arthritis inflammation of my lupus in my hands.

Follow Up in 4 weeks

To address my current problems with peripheral neuropathy, my rheumatologist prescribed Lyrica (pregabalin) to help reduce nighttime nerve pain, without having to resort to taking powerful pain killers to get to sleep.  I was surprized when I my pharmacist told me that Lyrica is not on my insurance formulary, and the drug requires precertification.  I cringed at the $350 it would be without my insurance, so my pharmacist contacted my rheumatologist to get the pre-certification process started.  Hopefully, my insurance will coöperate and the  approval will go quickly.  I will follow-up with my rheumy in four weeks.

Lupus when picking up paper hurts

turning pages was painful

My hands have given me a lot of trouble lately, and normal actions have been unusually painful.  Amazingly, I can play the piano without increasing my joint pain, but a few very simple tasks have been a different story! Today I was convinced it is time to get help.  Yesterday I found it hurt to rip open an envelope.  Today, I was sitting at my desk at work, turning the pages of a reference binder and realized that even picking up the pages and turning them was painful.  That was the last straw!

I think its time for help.  Lately I have had increasing trouble with buttons and zippers and have had to ask for help.  Even putting on socks or pantyhose hurts, but I am not about to ask anyone to help with those.  (Well, maybe my husband could help with the socks.)  Pushing down the button on the car door handle is almost impossible without using both thumbs, and opening snug jar lids or thermal mugs is downright impossible.  I have even had trouble getting my credit card out of my wallet.  The maintenance dose steroids are not helping.

It has been a long time since I last took non-steroidal anti-inflammatory drugs (NSAIDs) to control the inflammation in my joints and lupus arthritis, not since before Rituxan infusions several years ago.  Now, I think it is time to ask for them again.

I cannot take any of the over-the-counter varieties such as aspirin, ibuprofen or naproxen, so I need a prescription. Acetaminophen doesn’t count, since it is an analgesic and fever reducer, but not an anti-inflammatory drug, even though it gets grouped in with the NSAIDs.  After a major car accident almost 30 years ago, we tried all the different NSAIDs then available, and one I tolerated was an (old) seldom prescribed non-steroidal anti-inflammatory drug, sulindac.

drugs

After taking all the fancy new high-tech biologic drugs for my lupus that cost thousands of dollars per dose, maybe this old simple medicine that worked before will work again. Perhaps it is the small tree we missed in a vast forest of drug choices.  Sulindac had few side effects and controlled my ballooning joints effectively, long before I ever took methotrexate, azathiaprine, rituximab or belimumab for my lupus.

I’ve decided it is time to mention this new (old) idea to my doctors and see if they agree with my suggestion, or perhaps they will have a better idea.  I cannot accept the idea that lifting a piece of paper should  hurt!

Lupus and Benlysta – after 10 months & infusion #12

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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