Tag: biologics and IBD

Recognizing the touchpoints of independence along your IBD patient journey

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Take yourself back to the very first time you needed medical attention for your IBD (but didn’t know it yet). Close your eyes for a moment. Who was that person? Do you know them anymore? How have you changed and transformed since that life changing day?

I was diagnosed with Crohn’s disease July 23, 2005, at age 21. I was blindsided by a chronic illness after growing up as a literal picture of health. A three-sport, in shape athlete, who had never even had an ear infection or been to an emergency room. As a recent college graduate, my world flipped upside down as I struggled to find my way in the real world.

Now, 17 years later, I can tell you firsthand what I, you, and so many others have endured on our patient journeys and how each experience (even the mundane) serves as monumental touchpoints for gaining independence and confidence in making you a more empowered and direct patient. 

Let me paint the picture clearly for you

The first time you bravely laid in an emergency room bed and every time there after—not knowing the tests, pokes and probs, and physical scrutiny you were about to go through. 

How it feels to be wheeled by a stranger through stark hallways to CT scans, MREs, and scopes, wondering what the results will be on the other side and the repercussions for more medications, a longer hospital stay, or surgery.

The difference a couple months makes–pre-diagnosis in May 2005 and 2 months after 60 mg of prednisone a day and 22 pills a day.

What it’s like when you say goodbye to loved ones and they roll you into the OR and you’re shaking like a leaf, all alone and feeling frail and broken, alone with your thoughts and prayers.

The number of moments you’ve watched nurses and even rapid response nurses fumble with IV’s try after IV try and when it’s been more than five, you find your voice from that point forward and start only giving medical professionals two tries before it’s on to the next.

How it feels at the butt crack of dawn when the world is sleeping and the hospital is bustling, waking you abruptly to get more vitals and more labs and you lay alone, haggard, frustrated, and delirious. 

The moment when your GI has a heart to heart with you about starting a biologic and having to determine for yourself what route is your preference—infusion or self-injection. Would you rather sit for hours hooked up to an IV drip or sit on your couch with your kids looking on as you inflict pain on yourself. 

The times you’ve sat up in the middle of the night wide awake thanks to the prednisone kicking in while the rest of your world is asleep wondering if you’ll ever regain some semblance of control of life.

What it’s like trying to eat meals inconspicuously with your family while they not so subtly watch each bite and every trip to the bathroom with sadness and worry in their eyes.

How it felt driving to a first date or a job interview and feeling like your IBD is a dark secret looming over the conversation and not knowing when to take down your walls and share. 

Listening to your friends make comments about health and energy without considering what your experience with a chronic, debilitating illness may be like since you look well on the outside. 

What it feels like to look at your reflection in the hospital bathroom. Battered arms, sunken in eyes, a shell of who you used to be. But as soon as you walk out of the door, putting a soft smile on to protect your visitors from worry. 

What it’s like to sit on an airplane or be on a road trip with others and silently worrying about whether you’ll be able to make it and what your game plan will be. 

When you’re up in the middle of the night doing the second half of colonoscopy prep and wondering ‘why me’ in your 20s and 30s, feeling isolated in the physical, mental, and emotional anguish the process puts you through year after year. 

What you’ve internalized each time someone dumbs down your IBD, offers up ridiculous remedies or goes into a discourse about their aunt’s brother’s cousin who “healed” their Crohn’s this way. 

When you’ve waved the white flag and alerted family and friends that you needed help or to be seen in the hospital after doing as much fighting as you could against your own body.

The first time you bravely looked down at your incision and saw your body forever changed and came to see your scars as battle wounds. 

Waking up each day not knowing what the next 10 minutes will feel like for you and getting after it anyway. 

Not knowing if you’ll find your person, but meeting people and having the courage to share about your health issues, even if there are heartbreaks and disappointments along the way.

Deciding to have a baby and discussing family planning, despite all the what ifs and becoming a parent because that’s what you hoped for prior to your IBD. 

Landing that dream job with your IBD in your back pocket, not letting the detours stop you from finding the path you were meant to go on. 

Celebrate the independence you’ve discovered

The list goes on and on! No matter how old you are when diagnosed with IBD, in that moment we are robbed of our naivety and thoughts of invincibility, and we’re forced to go on a lifelong war and conquest. Our bodies no longer feel like ours. Our dreams feel in disarray. Our people may change and not be who you thought they were. Our hearts may break, but like a phoenix this disease can build you up just as much as it breaks you down. 

The reprieve of remission, while not perfect or without symptoms has enabled me to breathe and regain my grounding. In 2015, after three back-to-back bowel obstructions and 18 inches of my small intestine, Meckel’s diverticulum, and appendix removed, there was only one way to go and that was up. 

Give yourself grace. Celebrate the independence you’ve discovered that you may not be able to have realized until you’re years out like it took me. And when you’re in the hospital, in for a routine clinic visit or for labs, taking your meds and balancing every daily decision against how it will make your IBD feel, you’ll come to realize what you take on and all you accomplish every day just to survive and thrive, makes you something special. While you may feel dependent on others—and the support of caretakers and a support system can’t be understated, neither can the endless strength that lies within you.

A Switch in Specialty Pharmacies? How to Handle the Transition

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Coordinating medication through specialty pharmacies is somewhat of an artform for chronic illness patients. Unless you deal with managing this monthly, you may be unaware of the endless time and energy that goes into making sure all the ducks are in a row to keep everything on schedule with your gastroenterologist, insurance, and pharmacy.

A few weeks back, I received a letter in the mail explaining that beginning January 1, 2022, my Humira would be handled through a different specialty pharmacy. As soon as I saw the letter my first gut reaction was that I was being switched to a biosimilar. Upon further reading, I learned that Alliance RX Walgreens, my specialty pharmacy, will now be Accredo (through Express Scripts).

Letter I received from my previous specialty pharmacy.

What now?

As a patient who has been on Humira since July 2008, this is the fifth time I have had to switch specialty pharmacies. Previously, it was because I switched employers and had different insurance. This time around my husband’s insurance switched specialty pharmacies. And even though this is far from my first rodeo—as a person who depends on a biologic every 2 weeks, I worry about a lapse in my medication, so I’m being proactive by communicating the change with my care team.

The letter stating the change said everything for my Humira would automatically be switched over, as long as there were refills remaining. I wasn’t sure if I had refills.

Communicating with your care team

With the New Year holiday being this past week, I went ahead and wrote my GI on the Patient Portal. Here’s the correspondence so you see how it all played out from the back end (no pun intended!)

Hi Dr. G and team,

Wanted to give you a heads up that I received a letter that beginning Jan. 1 my specialty pharmacy that I go through for my Humira prescription will switch from Alliance RX Walgreens to Accredo (Express Scripts).

The letter states that my prescription will transfer automatically as long as I had refills on file with Alliance. I just wanted to make sure that was the case and that there was nothing we needed to do on our end to ensure a smooth transfer.

My next Humira injection is Monday, Jan 10–so I’ll be scheduling a delivery next week.

Thanks!

Natalie

Good morning, Natalie,

I updated your chart (removed Alliance Rx and put in Accredo) as your specialty pharmacy. I did send in a new prescription for your Humira to Accredo this morning that way they would have it. It does look like your prior authorization previously expired. I have notified Lori so that she is aware that a new auth may be required. I did want to verify with you that your insurance coverage will remain the same going into the new year?

Thank you for the heads up, we always appreciate it.

Thanks SO much. Yes, my insurance coverage is the same (has not changed). Appreciate your follow up!

Natalie

You’re very welcome. That sounds great, I have notified Lori so that she is aware that your insurance will remain the same, that way she can work on that new prior auth if it’s needed.

Perfect, thanks so much! Do you know if Accredo will contact me next week to schedule delivery or if I contact them the first go-around?

Natalie,

I would suggest contacting them. Lori is aware that we will likely need a new prior auth but you contacting them to schedule delivery will also initiate that process (if needed).

Will do– that’s helpful to know. I’ll plan to call them on Monday to get the ball rolling. Thanks for all your help, have a Happy New Year!

When someone receives medication from a specialty pharmacy know they are on the phone coordinating delivery every month, making sure prior authorizations, insurance, and drug savings cards are all in check. It’s like a never-ending homework assignment that’s constantly looming. Many specialty pharmacies have apps to help “simplify” the process for patients, but I’ve found that the times I’ve tried to use apps in the past, I still receive a phone call about ordering my Humira and never know if my online order even went through. Call me “old school” but I still prefer to order my medication over the phone each month for the past 13-plus years. Find what works best for you and stick with it!

As you can see, it’s helpful to have a care team that responds promptly on the Patient Portal and helps you navigate the ins and outs of ordering your biologic. Rather than being unsure and worried about when and how I’ll receive my next Humira delivery, I now feel confident that it will be a seamless transition. I highly recommend grabbing the reins and checking so you don’t end up in a situation where you’re scrambling to get your medicine on time. Being proactive saves everyone involved a lot of headaches.

IBD Motherhood Unplugged: My Personal PIANO Study Results

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As an IBD mom of three who stayed on my Humira (adalimumab) injections until late into my third trimester with all my pregnancies, I recognized the importance of contributing to ongoing research about the safety and efficacy of biologics. When I was approached to participate in the PIANO (Pregnancy Inflammatory bowel disease And Neonatal Outcomes) study for my pregnancy this past year I jumped at the opportunity. While I knew staying on my medication until 37 weeks pregnant would pass Humira through to my baby and that it is considered to be safe, I didn’t know much beyond that.

My son Connor is 8 weeks today. The day of my C-section blood samples were taken from him, me, and my umbilical cord. The purpose of the samples was to measure the concentration of the Humira at the time of delivery. The process in the hospital was simple. Detailed instructions were mailed to me at home ahead of time. When I walked into the hospital for my scheduled C-section my husband and I handed over a small box that included three vials, an ice pack, and proper packaging for the transfer from St. Louis to California to the nurse who was prepping me for surgery. Once all the samples were ready to go my husband made a quick stop at FedEx to hand over the package and voila the science of it all was on its way.

The Results

The past few weeks we’ve anxiously awaited the results. This week, we received them. I have an almost 4.5-year-old son, a 2.5-year-old daughter, and a newborn. With each pregnancy—Crohn’s-wise, the experience was flawless. I felt like a “normal” person. Foods that typically trigger me, didn’t cause any issues. If I wanted a cup of coffee, I didn’t pay the price. It felt glorious to have zero abdominal pain for all those months and know that my babies were thriving in utero. I credit my own health and deep remission and my children’s health to the fact that I chose to follow my care team’s recommendations and stay on Humira until the final weeks of my pregnancies.

When the results popped up in my email inbox, I was nursing Connor. I felt a few emotions, more than I had anticipated. I hesitated to open it. Even though I could see Reid and Sophia watching TV and know how healthy they are, it still made me feel a rush of mom guilt to know that I needed a heavy-duty medication to bring all three of my children into this world and that even though studies like PIANO have shown the safety profile, that as IBD moms we still worry and wish we didn’t need to do injections or get infusions while a life is growing inside of us.

I texted my husband Bobby while he was at work and expressed how I was feeling. His response, “It’s all good babe, I’m sure it’s emotional but kids are all healthy and in good shape so just thankful for that. You did good.” Having a supportive partner through your patient journey and especially through parenthood makes all the difference.

Here are my PIANO study findings. I stopped medication at 37 weeks, and my last injection was 16 days prior to C-Section and this blood test.

My blood—7.3 mcg/mL

Connor’s blood—6.8 mcg/mL

Cord blood—5.9 mcg/mL

When I saw the numbers, my eyes filled with tears. Even though just looking at the numbers didn’t mean a whole lot, it just showed me that my baby had medication in his system, and it made me feel sad. I knew this would be the case—but I want to be transparent that it did upset me, even though I know it was for the best and have seen how my other children have thrived despite their exposure.

I waited to share this so the PIANO study’s lead organizer, Dr. Uma Mahadevan could weigh in and provide further explanation for not only myself, but for our community. She told me that in the PIANO study,  the concentration of Humira for baby on average is 9.4 mcg/ml (range 2.5-26) and for moms 25 mcg/ml (range 0-56.4). As stated above, I was at 7.3 mcg/ml and Connor was 6.8 mcg/ml.

“Cord blood is the blood from the baby that is left in the umbilical cord and placenta after birth. It comes from the baby, so those concentrations are similar. Beginning around week 14 of pregnancy the placenta has a receptor called FcRn. This grabs antibody by the “Fc” portion and pulls it actively from mom to baby. This is most efficient in the third trimester when 80% of antibody transfer occurs. Since Humira is an antibody, it gets pulled across the placenta as well.”

Dr. Mahadevan went on to say that baby often has more drug at birth than the mom, but that was not the case for me. The PIANO study has shown several positive outcomes for IBD moms:

  • There is not an association between the amount of drug present in a baby at birth with infections.
  • Even though there was no increased risk of infection seen based on exposure to anti-TNF or on drug level at birth, in theory these babies (like Connor) are considered immunocompromised until no drug is present. For Humira that’s about 3 months, for Remicade (infliximab) that’s about six months.

“My advice to moms is that all the risks to the baby seem to come from disease flare rather than from medication. In a large French study, the risk of infection in baby was in moms who flared in the third trimester, not based on anti-TNF exposure. Risk of pre-term birth is increased with disease activity, not with anti-TNF medication. Risk of miscarriage comes with disease activity, not anti-TNF use. There is a clear and significant risk from having a flare during pregnancy. Compared to babies of IBD moms not exposed to medications, there is no evidence of increased harm to the baby (at least out to 4 years of age) from TNF exposure,” explained Dr. Mahadevan.

Hearing this was music to my ears and was extremely comforting. Point being—there’s a much greater likelihood of pregnancy complications if your IBD is not managed and if you flare than if you stay on your medication and keep your IBD controlled.

“We have completed our breastfeeding study which showed very minimal transfer (a fraction of what transfers by placental blood) and no evidence of harm to baby for breastfeeding when a mother is on anti-TNF.”

Knowing this about breastfeeding gives me great peace of mind as I continue the journey with my son, while still managing my Crohn’s by taking my Humira.

I also want to add that Dr. Mahadevan and her research team have been a huge support to me throughout the entire study. When she read a draft of this article and saw how I felt when I received the email with the blood results, she asked for recommendations about how to better deliver the findings to women. This meant a lot—I suggested sharing the range in blood concentration similar to how lab results are delivered on a patient portal and following up with an email or phone call to explain what the numbers mean further. Those touchpoints of support can make a big difference. I also shared my results over the patient portal with my GI and she called me to discuss them as well, which was helpful.

My three miracles. All healthy. All here safe and sound. Growing and thriving, despite exposure to biologics.

Interested in participating in the PIANO study? There’s always a need for more women to enroll! So far, 1,700 women have done so. There’s especially a need for women on newer drugs like Stelara, Entyvio, and Xeljanz. Click here to get involved.