Lupus and Benlysta Infusions – After 18 months

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.)

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, 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.

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 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

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

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

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

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!

Diagnosis and Treatment of Lupus: Fact #12 – Lupus requires multiple medicines!

Diagnosis and Treatment of Lupus:  Successful treatment of lupus often requires a combination of medications. A new treatment for lupus was approved recently, and nearly two-dozen clinical studies are underway to develop a full arsenal of treatments. My treatment plan and combination of drugs used to control lupus and its various symptoms has changed over the years to respond to the variations in my lupus activity, symptoms and organ involvement.

First, aspirin

Many patients with mild to moderate lupus are taking over-the-counter anti inflammatory drugs as a first defense in controlling the symptoms of lupus arthritis and its pain, stiffness and joint swelling. For years I was treated for arthritis of unknown cause, after repeatedly ruling out rheumatoid arthritis through many negative lab tests for it. My family doctor prescribed 10 aspirin per day, in trying to control my inflammation. This was about five years before my lupus diagnosis, when I was new mom in my mid twenties.

Next, Disalcid

Next, my doctor tried the drug Disalcid, after aspirin was inadequate and began causing bleeding from my mucous membranes.   Next, my doctor had me try many non-steroidal anti-inflammatory drugs (NSAIDs) bit I was unable to tolerate most of them. Naproxen caused sharp abdominal pain and Ibuprofen caused bleeding similar to the effects of aspirin.

Then, Sulindac

Eventually, my family doctor put me on an old seldom prescribed anti-inflammatory drug Sulindac because of my intolerance for all the other NSAIDs we had tried.  This was well-tolerated and seemed to control joint inflammation, and helped keep my knuckle joints from ballooning.  This drug was continued for over twenty years, even after my lupus diagnosis and treatment began with lupus medications, because it was still so well tolerated and effective.  Attempts to withdraw this anti-inflammatory medication over the years always resulted in the return of pronounced joint swelling.

Repeated steroid treatments

During those early pre-diagnosis years, there were recurring bouts of discoid raised skin rashes treated with topical steroid ointments and occasional oral and injected steroids.  The multiple use of steroids for the undiagnosed lupus symptoms became problematic, and the doctor began being concerned heavy recurring use of steroids was not medically responsible.  We were frustrated with no answer for my arthritis symptoms, mouth and nose ulcers, rashes and other symptoms before the diagnosis of lupus was finally reached.

After diagnosis, Plaquenil, Sulindac and Tylenol

First post-diagnosis treatments included Plaquenil, continued Sulindac, prednisone and extended-relief Tylenol medications.  For many years this was adequate with bursts of steroids or injections when symptoms would flare and increase from time to time.  There was a gradual worsening of my lupus over time, and eventually stressful life events helped trigger organ involvement in my central nervous system, peripheral neuropathy, liver and overall increased systemic inflammation, joint pain and broad spread lupus activity.

Eventually, Methotrexate and Imuran

For the next ten years, my treatment plan included adding weekly Methotrexate treatment and daily Imuran doses to control the more severe symptoms, but eventually even this combination of medications were unable to control my worsening liver and central nervous system symptoms.

Rituximab, remission and now Benlysta

I entered a clinical trial of the biologic drug Rituximab, and quickly entered into a five-year near remission of the worst of my lupus symptoms.   All my lupus medications were withdrawn except for baseline Plaquenil, occasional Tylenol and smaller short steroid intervention for occasional mild flares.

Recent stressful life events ended the extended remission, and recently the new biologic drug Benlysta became a mainstay of my lupus treatment.

Benlysta was approved by the FDA in March of 2011, and is the first new drug in over 50 years to be approved by the FDA for treating systemic lupus.  Prior to this, only three other drugs were FDA approved for systemic lupus:  Aspirin, Prednisone and Plaquenil.   I am currently receiving monthly Benlysta infusions and have experienced moderate gradual reduction in lupus activity with this medication.

Many drug combinations for lupus

Many other drug combinations are used to treat different lupus patients, and the drugs that they need change over time as their lupus activity and symptoms change.

To read more about drugs and combinations of therapies used in treating lupus, check out the information at the Lupus Foundation of America on this subject.

Lupus and the first rolling shopping adventure

Christmas in April?

Christmas shopping is a funny topic in April, but as I was thinking about firsts with lupus, I realized that my first rolling shopping mall trip was one of my most memorable lupus firsts.  Many years ago, when Christmas was approaching, I had to face the fact that shopping and the mall had been my absolute last priority, as I struggled through an intense long-lasting arthritis flare of my lupus.  Walking was extremely difficult because of swollen and painful feet, knees and ankles, along with overwhelming bone-tired fatigue.  Because my husband had never done the Christmas shopping alone without me, he devised a plan to accommodate my severely narrowed physical abilities and endurance.

Arriving at the mall, we approached the customer service kiosk as my husband informed me he wasn’t going to let me wear myself out shopping.  Dismissing my protests, he spoke with the mall staff and checked out a wheel chair.  Pointing to the seat, he said, “let’s go for a ride.”  It felt uncomfortable at first sitting and depending on him to push me around.  I struggled with the strangeness of my new mall perspective.  Sitting at a lower eye level than standing, it was reminiscent of walking beside my mother with my hand in hers, and not being allowed to walk around at will.

View from the wheelchair

There was an uncomfortable feeling of frustrating helplessness.  I had to tell my husband each time I wanted him to take me closer to something, and when he was looking at something, he would push me just past it, with my back to what he was looking at.  It took awhile before we communicated well about how the wheel chair was changing my shopping experience.  I didn’t like that we were not walking hand-in-hand as before, but rather he was behind me and often didn’t hear what I said.  I was along for the ride, and I certainly didn’t feel like I was in charge!  I didn’t really like it.

However, shopping from a rolling perspective was also a great relief because of the extreme fatigue and pain my lupus caused, in or out of the wheelchair.  As we gathered many purchases, I soon had a full lap and was competing with the gifts for space in my wheel chair.  By the end of the trip, I was exhausted, and greatly appreciating the wisdom and leadership my husband had demonstrated when he insisted on carrying out his plan to keep my strength.  I realized in retrospect that I would have been absolutely unable to endure the shopping trip that we had enjoyed that day together, spanning many hours and every corner of the mall.  I had to acknowledge how much my lupus was disabling me.

Others helped me get around

This was not the last of my rolling shopping excursions.  After that, most of my other shopping trips in malls, departments stores and grocery stores were from a wheel chair for a while.  For the next three years or so, my lupus continued its exhausting, crippling flare, despite the cancer and transplant chemotherapy drugs I was taking to control it.  My lupus even progressed to where one Christmas I didn’t go to the mall at all, and all my shopping took place from my home office desk chair.  That year all our gifts were ordered over the Internet and delivered to our house.

It was a full four years before I eventually ventured briefly into a shopping mall again on foot, and almost a full ten years before I was able to stroll through a mall from one end to the other on foot.  Even now, I have to carefully consider my footwear and stamina when planning to go to a shopping mall.  Often, I strategically plan to visit one shop, parking near by it to cut my walking distances.  After treatments several years ago with infusions of the biologic drug Rituxan, my lupus never returned to its earlier severity.  Although it has been many years since I had to do my Christmas shopping from the seat of a wheelchair, I will still never forget the adventure of my first rolling shopping trip!

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

Rituxan v. Benlysta?

Benlysta infusion treatments for my lupus have turned down a slightly bumpy road.  So far, Benlysta has seemed to produce gradual, but not dramatic, improvements in my lupus symptoms. However, bronchitis set into my respiratory system within 48 hours of my last infusion, and this is not the first case of bronchitis.  Additionally, over the following few days, a low-grade fever persisted while taking antibiotics, and lupus symptoms continued increasing.

Despite modest gains from Benlysta, my auto-immune response shifted into overdrive, perhaps in reaction to the infection.  My lupus symptoms had increased severity.

Increasing lupus symptoms

Besides increasing fatigue and inflamed joints, CNS lupus symptoms re-emerged and I was having serious trouble thinking clearly.  Making decisions as simple as picking what to fix for dinner were getting increasingly difficult,.  My memory was obviously affected and my family began seriously talking to me about the confusion they were noticing.  My husband, daughter, and son-in-law who live with me expressed their growing concern about my noticeable CNS Lupus symptoms.

Although the bronchitis responded quickly to a few days of Zithromax, at week’s end my lupus related auto-immunity kept building, with no apparent intent of backing down.

Waiting for Benlysta

It is tempting to adopt impatience toward the slow pace of Benlysta’s effectiveness.  After consulting with my rheumatologist last week, I am determined to sustain my optimism for Benlysta’s potential long-term effectiveness.  The literature indicates that we are just now reaching the point when Benlysta could start making a significant difference.  We knew from the beginning that Benlysta is somewhat slow on the uptake, precisely because of how it works.  This drug needs time to show its effectiveness, and it’s necessary to stay (a patient) patient.

Finding the contentment to wait for results is difficult, because it is only natural to compare this Benlysta experience with what happened after Rituxan infusions.  Six years ago, I received two Rituxan infusions in a Phase III Lupus Clinical Trial conducted by Genetech.  Rituxan quickly ushered me into an amazing five-year near remission.

Rituxan, the proverbial hare

The tortoise and the hare.  The difference between the speed of the two medications, Benlysta and Rituxan, is stark and a little hard for me to accept.   Both are very expensive! In fact, a year’s supply of Benlysta (12 infusions) and a year’s supply of Rituxan (3 infusions) cost somewhere around $30,000 to $40,000 for either biologic medicine.  My insurance paid the negotiated in-network reduced price for the year of $19,000 to the infusion hospital for FDA approved Benlysta, but denied multiple appeals to fund Rituxan.

Benlysta, slow and steady

Because my response to Rituxan was so amazing, in comparison, Benlysta’s performance now seems a little mediocre.  Will Benlysta be worth the cost of time and money?  So far, I think it is too early to decide that.  My enthusiasm about Benlysta’s effectiveness has been moderated a little, but we will follow the course of treatment to see the final results.  I am going to give it all the time my doctor recommends.

Perhaps the tortoise Benlysta, slow and steady, will win the race to control my Lupus symptoms.  The jury is still out.

Lupus, and Benlysta in my future…

Time to go a new direction...

My rheumatologist said it is time to give up and seek a new drug for my lupus.  After over six months of appeals trying to get infusions of Rituxan (Rituximab) approved that I had in a clinical trial 5 years ago, the insurance door is now shut.  We hoped to get approval again because of my dramatic improvement and near-remission after two 1,000 mg infusions of the biologic drug Rituxan.  Costs for those infusions were split between the drug company clinical trial for the medication and my insurance company for the infusion center and procedures.  It made sense to use a drug again that worked so amazingly well.  Lack of FDA approval of Rituxan for use in lupus was the insurmountable bar to getting it approved.

What did Rituxan Do?

What did Rituxan do that helped me so much?  Let’s talk briefly about the science behind the medicines.

Rituxan is a murine monoclonal antibody.  It worked by killing the B cells in my blood  causing the auto-immune response in lupus.  B cells make antibodies that turn the immune system against unwanted invaders, and unfortunately in lupus, also against the body’s own cells.

B cells are lymphocytes with a role in immune response that create immune antibodies.   B cells are receptors for Blys proteins (B Lymphocyte Stimulator  285-amino acid long peptide glycoproteins) made by Myeloid stem cells  in bone marrow.   Blys stimulate the B cells to produce auto-immune antibodies.   The first medication trial that successfully met its goals in treating lupus targeted Blys cells, destroying them earlier in the auto-immune process.  Controlling Blys interrupts the auto-immune response one step earlier than Rituxan does by depleting B cells.

Rituxan does not kill B cells in certain tissues or “baby” B cells that are still developing in bone marrow.   As a result, somewhere after about 4-6 months, the fledgling B cells matured and ventured out from my bone marrow back into my blood stream to do their job again.  However, this time, the new generation of B cells was acting much more normally.  The escalation of my lupus that had progressed over years to a multi-organ damaging severity was reset back to a moderate level near the beginning.

My improvement was simply amazing, and Lupus had suddenly changed its severity and course:

• Liver damage stopped
• Central nervous system involvement quieted
• Arthritis join pain and inflammation disappeared
• Colon inflammation stopped
• Mouth and nose ulcers vanished
• Dry mouth and eye symptoms resolved
• Discoid and malar rashes were gone
• Malaise went away
• Fatigue was almost absent

All of these improvements began to happen even before having a the second infusion 4 weeks after the first.  The change was very dramatic and incredible.  For the first time in over twenty-five years I awoke nearly every morning pain-free, clear-headed and feeling good.  After almost ten years, I no longer took the cancer and transplant anti-rejection drugs Methotrexate and Imuran, nor did I need Ultram for pain.  My steroids reduced to a maintenance dose of 5 mg of prednisone per day.  For the first time in over twenty-five years I was able to stop taking the anti-inflammatory drug Sulindac, which I needed constantly to prevent my fingers joints from ballooning to double their normal size due to my lupus arthritis.

Why didn’t Rituxan get FDA approval?

Unfortunately, the clinical trials (including the one that helped me) failed to meet their specified goals and were inconclusive.  However, researchers learned how to improve their clinical trial methods from those failures.  The failures were not necessary due to Rituxan’s failure to help patients, but rather due to the inability to prove conclusively that the clinical trials provided specific answers.  They realized that clinical trial  design needed modification to get conclusive results.

The patients in the Rituxan clinical trials were using a number of other drug treatments at the same time.  This weakened the researcher’s ability to decide if improvement was because of Rituxan or the other drugs the patients took for their lupus during the clinical trials.  Many were taking chemotherapy drugs, and were using prednisone as needed to suppress lupus flares.  Generally many patients improved over the trial, but it was impossible to prove which drug had helped them get better.

We already know that it works, and is now FDA approved for rheumatoid arthritis.  Most lupus treatments are borrowed from treatments successfully used for rheumatoid arthritis.  I hope that more testing of Rituxan for lupus happens in the future.

What is next?

My doctor is now submitting a request for approval of the new biologic lupus drug, Benlysta.  The first clinical trials for lupus treatment that have ever worked were testing Benlysta, and now the FDA approved it specifically for treating Lupus in March of this year.  Benylsta works similarly to Rituxan, and it is also a monoclonal antibody.   It targets the immune system one step earlier in the auto-inflammatory response, causing reduction of Blys.  This reduces the number of triggers that activate B cells in lupus.  The studies show that Benlysta helps many lupus patients, although the results don’t sound as dramatic as those that I received after Rituxan.  My doctor anticipates being able to convince the insurance company to pay the five-figure annual costs for Benlysta infusions.

If approved, there will likely be three 1-hour infusions, two weeks apart, and then monthly after that.  I am encouraged and anticipating that I may soon be feeling better.  You can find out more about Benlysta at the following sites:

http://www.benlysta.com

http://www.lupus.org/newsite/pages/BENLYSTA-file.wmv