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!

World Lupus Day – Treatment of Lupus: Fact #10 – It is expensive!

TODAY is World Lupus Day!

The Diagnosis and Treatment of Lupus:  Lupus can be an expensive disease.

The Lupus Foundation of America (LFA) reports that “the average annual cost to provide healthcare for a person with lupus is $12,643, and rises to nearly $21,000 when lost work productivity is included.” However for those of us who are receiving the new biologic drugs, the real cost to our insurance companies is now many times greater than treatment with the standard medications included in the LFA’s estimates.

Biologic Drug Infusions Cost More than other treatments

Costs for the New Biologic Drugs are More

I recently discovered that the real cost to my self-insured employer for my first nine Benlysta infusions was about three times the amount estimated in the literature I had read from the drug company. In a conversation with my rheumatologist, he validated that the charges were reasonable and customary for infusions administered in an outpatient hospital setting.

Apparently, the published cost estimates for Benlysta of about $40,000 per year are based upon the costs when infusions are administered at the rheumatologist’s office. The drug is ordered through a pharmacy by the physician, and paid for through the patient’s prescription coverage and applicable co-pays.  However, in a hospital outpatient setting the drug is paid for under a patient’s major medical insurance coverage.

Costs for Lupus Treatment have risen

Costs have gone up in recent years

In comparison, several years ago when I had two Rituximab infusions, the entire billed cost for both eight-hour infusion sessions in a hospital outpatient cancer infusion center cost about $38,000. The drug costs were paid by Genentech, the drug manufacturing company under a Phase III clinical trial for lupus. My insurance company agreed to pay the $3,000 required for the outpatient infusion center and the infusion procedures each time.

My other medications cost my employer and me thousands of dollars each year. While also treating for asthma and allergies, the majority of my medication costs are borne by my self- insured employer through a health insurance company working as the third-party administrator.  My coverage has an annual stop-loss of $1,000 for my prescription co-pays, which is a great blessing.  The stop-loss helps keep a predictable limit on my out-of-pocket medication costs each year, but the $1,000 I pay is a small fraction of the total prescription costs paid by my employer’s health insurance plan.  After mid-year when my co-pays reach $1,000, my remaining prescriptions for the year have no more co-pays.

Total costs are more with late lupus diagnosis

Total Medical Costs, Even with Co-Pays are High

Other medical costs include medical co-pays.  My rheumatologist is not a member of any of the health maintenance organization (HMO) insurance plans, as his thriving practice does not financially require him to submit to the limitations of the insurance companies for his livelihood.  My primary care physician, who is a member of my insurance plan, coördinates and supports the recommendations of my rheumatologist for my care.  I pay the full price for all the office visits with my rheumatologist, usually somewhere between $85 and $140 per visit.  This extra amount per visit over the amount I would pay to see a specialist on my health insurance plan ($35) is a small price to pay to get an expert in lupus to manage and oversee my treatment plan.  Every year I pay a few hundred well-spent dollars to my rheumatologist.

All procedures, lab work and diagnostic exams are paid through my primary care physician and providers covered by my insurance, without any co-pays for most of these services.  My total out-of-pocket co-pays and prescriptions usually total around $3,000 per year.  I estimate the total costs to my insurance plan are an extra $130,000 to $150,000.   Before the Benlysta infusions, the total costs were probably closer to $30,000 to $50,000 in years I had no hospitalizations.

Why are my total costs so high, compared to the estimates from the LFA?  My lupus was not diagnosed until it had escalated to a more advanced level and eventual organ involvement.

World Lupus Day is May 10, 2012

Why is lupus awareness so important today, on World Lupus Day?

The early diagnosis and treatment of lupus helps limit the severity and mortality of lupus.  If I had been diagnosed as a child and treated with the normal standard care for lupus throughout the first half of my life, my lupus might have remained in a mild state.  The progression to organ involvement also means the increase in costly payments and medications, providing there are funds and coverage available to pay for them.

For women without insurance resources, the early diagnosis and treatment of lupus is even more critical!

Efforts to treat mild lupus, and keep it from progressing and worsening will limit the extent of severity and costs for treatment throughout the life of a lupus patient.  The costs for treatment of mild lupus, controlled by Plaquenil and occasional steroid medications, might stay affordable and available for most patients, even if they have no insurance coverage.

The costs of treatment like what I receive for my lupus are absolutely unavailable to most patients without insurance coverage or even funds to pay their sizable co-pays.  I am grateful and thankful for the resources available to me to pay for my lupus medical care!

World Lupus Day – Sign the Pledge!

Early lupus diagnosis means a longer healthier life and lower medical costs

Lupus awareness means patients are diagnosed earlier.  Earlier diagnosis means less severe lupus over the course of a patient’s life.  Less severe lupus means less risk for organ damage and lower mortality rates.  Lupus awareness means improved lupus quality of life and longer life span for every lupus patient who is diagnosed and treated in a timely manner!

Sign the World Lupus Day Pledge!

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.

Benlysta Infusions for Lupus – Day 90 – Thanksgiving

Thanksgiving Day

Thanksgiving Day is the 90th day since the start of my Benlysta infusions for Lupus.  Just one year ago, my doctor and I were deep in a battle trying to get insurance approval to resume Rituxan infusions to try to get me back into a some level of remission.  Now, that insurance battle is old history, after having my 5th Benlysta infusion this week.

I am very thankful for the changes I already see in my health because of Benlysta.  Mornings are very different, waking up with improved mental clarity instead of cloudiness.   Lupus arthritis pain in my joints, muscles, bones and tendons seems to keep reducing a little more with each of the past few weeks.  My energy level has been raised noticeably, and I am optimistic about the long-term outcome from Benlysta infusions.  Gradual improvements just keep inching along to elevate my overall health and sense of well-being — not dramatically — but rather, slowly and systematically.

Today gives me an opportunity to pause and reflect upon many things in my life which cause me to kneel and gratefully thank my Creator for richness, fullness and blessings in my  life.

My thoughts turn to my husband, my children and children-in-law, grandchildren and many other precious family and friends surrounding me and enriching my daily life.  I am grateful for the unconditional love of a forgiving Savior, Jesus Christ, and the Christlike unconditional love of those closest to me who walk with him daily.  They love me, complete with my shortcomings, limitations and illness.  They give, support, encourage, care and share burdens with me and I with them.  I am thankful that they even sometimes worry about me.  Such selfless love is the most priceless and precious of gifts one soul can give to another.

I even thank God for my lupus.  I would wish it away in a heartbeat if that would really be possible.  However, the lupus has been a part of my life experience throughout the past couple of decades, and for many, many years before that when it had no name.  It is a part of me that I cannot change.

I even thank God for my lupus

Lupus brought with it a need to depend upon God and others for the strength and ability I so often lack.  Lupus means learning to accept and live within narrowed limitations, while learning about personal peace and contentment.  Lupus means learning to prioritize what is most important, since I am unable to do everything I would like to.  Lupus means learning to have compassion toward others who have similar challenges to mine, because I know what it is to struggle just to feel good and do the basic things of life with a physical burden.   Because of Lupus, I am stronger, more determined and perhaps more real than I would be without it.

But today, I thank God also for Benlysta, and for the many, many people that invested their money to bring it to market and provide for years of research, development and clinical trials.  I am thankful for the FDA committee that saw beyond political correctness to approve a drug for lupus that still needed more efficacy testing in treating women of color.  I am thankful for the patients who had the courage to engage in Benlysta clinical trials without knowing if it would help them.  I am thankful for my doctor who was willing to prescribe it.  I am also thankful for the generosity of the manufacturer of Benlysta, who provides patient support and financial copay assistance programs to the lupus patients who need it.

Today, I see how much my “glass” is so much more than half-full, it is full to the brim and spilling over as I carry it through each day of this adventure!  Today, I thank God for who He is, and for the life and light He gives to me.  On this Thanksgiving Day, I praise Him for His greatness and great love.

Lupus, and praising God for scheduled Benlysta infusions!

The joy of the Lord is my strength!

It is a painful, slow-moving Sunday morning for me, but I am praising God today!

After months of insurance appeals, my infusions start on Aug. 26th of the first new FDA approved lupus drug in over 50 years, Benlysta.

Cancer chemo drugs that helped for 10 years stopped when lupus attacked my liver six years ago. Then, infusions of a clinical trial drug caused an amazing near-remission that ended about 18 mo. ago.

Lupus is now attacking my brain, joints, tendons, skin, nerves and body again, causing increasing lesions and tissue damage inside and out.

Hopes for less pain, weakness, bone-tired fatigue, and mental clouds each day are a wonderful prospect.

God is faithful and His joy is my daily strength!

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