The Patient Experience: What the IBD Community says about Entyvio

Starting a biologic or switching to a new one after a drug fails you is a stark reality for many with IBD.  I personally have been on the same biologic since July 2008. Lucky for me, my body hasn’t built up antibodies and it’s served me well in managing and treating my Crohn’s disease. Recently, a woman with Crohn’s disease private messaged me on Instagram. She’s been on Humira (adalimumab) since 2006, but she’s no longer responding to it. Her gastroenterologist has advised she start Entyvio (vedolizumab).

Like anyone who deals with a drug failing them, she’s reached a level of comfort giving herself injections and knowing the ins and outs of the medication she receives. Now, 15 years later, she feels a bit like a fish out of water trying to navigate a new biologic and all the unknowns that come along with that transition, especially because she hopes to start a family in the next year.

After hearing from her and wanting to help, I went out on a limb and shared the following on my Instastory—to try and comfort her as she embarks on this new chapter in her treatment. “Hey IBD fam! Let me know if you’re on Entyvio and what your experience on it has been thus far. Looking to get info for someone who has been on Humira since 2006 and is making the switch after losing response to it. Appreciate your help and insight.”

The overwhelming response from the community

Several people wrote me directly about their experience with Entyvio—everything from tips and tricks to minimize side effects to how Entyvio has improved their quality of life or been detrimental to it. The response truly blew me away. We all know, IBD presents uniquely in each of us. So, one person’s experience with a biologic (or anything for that matter in treating Crohn’s or ulcerative colitis) must be taken with a grain of salt. At the same time, there’s a sense of camaraderie in connecting with those who use or have experienced your same therapy.

Since I’ve never been on Entyvio, I learned a lot in the process…and wanted to share my findings from these direct message discussions with you. Entyvio is known for its low side effect profile, as it specifically targets the gut. My hope is that this will help alleviate people’s concerns and help educate the community, should Entyvio be offered up as a possible treatment plan presently or in the future for you. (NOTE: I am writing this on my own accord—with NO affiliation or guidance to pharma). This is strictly created from IBD patient experience.

Infusion: Dosing schedule + timing

Generally, the recommended dosage is a 30-minute intravenous infusion, every 8 weeks. Depending on a patient’s response, this can shift to every 6 weeks or even every 4.

“Been on Entyvio since it was approved by the FDA. It has been very helpful since it targets the gut. I am on supplemental IBD meds, but I like that it’s a fast infusion and has given me my life back. It’s the longest I’ve ever been on a biologic, too.”

“It’s about an hour total to get the IV, wait for the med to be mixed, and have the infusion. I am noticeably tired the day of the infusion, but then bounce back quickly by day two. No other side effects at all. Entyvio has been a lifesaver for me!”

While some people saw improvement after the loading doses, Entyvio is known to react slower than other biologics. While most of us are used to biologics taking 2-3 months to work their magic, several people stated their GI warned them ahead of time that Entyvio could take 8 months to a year to be fully effective.

Side effects: The consensus among those who responded

Headaches/Dehydration/Fatigue

“I take Tylenol and Benadryl at every infusion because I found when I didn’t, I ended up with really bad headaches. I seem to feel better if I exercise for a little bit after my infusion, like walk 20 minutes or do 20 minutes on a bike. Real slow and easy. I often feel tired that day and maybe the next day, but after that I’m pretty much golden.”

“A lot of people get headaches after the infusion—they think from dehydration, so it’s helpful to ask for an extra bag of saline fluids during the infusion.”

“My friend and I both get tired after our Entyvio infusions. We both need a good nap after and then we feel fine. Hydrating the day before, during, and right after the infusion helps a ton.”

Hair Loss/Growth

“I lost a LOT of my hair while on this and had to take a large amount of prednisone for almost a year to get back on track because this medication. Please do research on this one! I did not do much and read a lot of people lost almost all their hair. Thankfully, mine grew back while I was pregnant. It was a big bummer! I’m on Stelara now and it works just as well as Humira did for me before my response to it also declined.”

“Been on Entyvio about 2.5 years and it’s the only drug to get me into remission! Was on infliximab (Remicade) before and became allergic and lost response. Minimal side effects with the Entyvio as well! If anything, I just noticed my hair doesn’t really grow the same.”

Navigating infusions and life

While the shorter infusion time is a plus, nothing beats the convenience of an at-home injection. At the same time, several patients shared the benefit of setting up an at-home infusion, so that’s something to look into versus going into a medical facility to receive your medication.

“I have ulcerative colitis and I’ve been on Entyvio for almost a year now. It’s the first biologic I’ve been on and it has helped a little, but it hasn’t been able to heal my rectum at all. I’m in a teen support group and one of the group leaders has had the same experience. After the starter doses, I was on every 8 weeks, but my drug levels were too low, so we switched to every 6 weeks and that didn’t do anything either. Since my symptoms were increasing, I was moved to every 4 weeks as of November. I honestly wish I were on Humira or another at home injectable only because I’m 18 and want to have a normal life that isn’t tied to needing to be home or to go the hospital every month, but it is what it is. The infusions don’t take long, but I do come home and sleep for the rest of the day. I started a pediatric clinical trial about a month ago since the Entyvio isn’t doing enough, but I still have to stay on the Entyvio.”

Pregnancy and Breastfeeding

For guidance on pregnancy and breastfeeding in regards to Entyvio, you can find helpful information at the IBD Parenthood Project and through the PIANO registry study. You can also connect with IBD Moms and Mamas Facing Forward, social media communities comprised of women living your reality.

Prior to planning to conceive, it’s always a good idea to communicate your family planning goals and dreams with your care team. Let your GI and OB know that you’re hoping to get pregnant 6-plus months ahead of time, so they are clear on what your expectations are. That way, you can put your best care plan in place, especially as it comes to staying on top of managing your IBD while you bring a life into the world.

“It was the first biologic that actually showed healing on my colonoscopy. I was on Entyvio my whole pregnancy, and now I’m breastfeeding on it.”

“I have been on all biologics and have had the best response to Entyvio. It put me into a 3.5-year remission (my only remission ever) and allowed me to have my son. Unfortunately, it does not target perianal Crohn’s, so I have had issues over the last few years. After trying Stelara, I had to go back to Entyvio because it’s the only drug that treats my luminal Crohn’s. It really is an amazing drug. No side effects for me, and my immune system is stronger than it has ever been—on the other drugs, I caught a million colds and would get bronchitis and pneumonia several times a year. Since being on Entyvio, I think I’ve gotten a cold a year (maybe?!), it’s a dream!”

“I have been on Entyvio for about two years now and it has been lifechanging. In terms of my ulcerative colitis, it has been day and night, and it has even gotten me into remission! I do feel really tired after my infusion and a little bit into the next day, but since I only get them every 8 weeks, that is a side effect I am more than willing to take on! I was on Entyvio for my entire second pregnancy and that was a breeze compared to my first.”

Be a proactive patient

Like many biologics and prescription drugs, there is a patient savings program available that you’ll want to check out. Learn more about Entyvio Connect here.

Helpful Entyvio-Focused Facebook Communities

Several of the people who responded shared they’ve had positive experiences and found support in Facebook groups geared for those specifically on Entyvio. Check them out:

Entyvio Mommas

Entyvio Warriors

Thanks to everyone who went out of their way to share their experience and help a fellow IBD warrior in need. Having this type of intel is good as gold and extremely beneficial in empowering patients as they make drug and treatment choices.

Participating in PIANO: Why I choose to be a part of research while pregnant and beyond

As an IBD mom I see it as a responsibility and an opportunity to participate in research studies while I am pregnant and as my children grow. I’m currently 20 weeks pregnant (tomorrow!) with my third baby and this time around I’m enrolled in the Pregnancy in Inflammatory Bowel Disease and Neonatal Outcomes (PIANO) study. The project was conceived, lead, and executed by Dr. Uma Mahadevan, Professor of Medicine at the University of California San Francisco in 2007.

Since the project launched, more than 1,800 women have participated in the registry. Of that number, over 900 stayed on biologics throughout their pregnancies. I’m thrilled to be a part of this initiative. If my pregnancies and children can provide clarity for a future generation of IBD moms, the extra effort on my part is more than worth it. Thanks to women before me who have been on a biologic and been a part of research while pregnant, I have peace of mind knowing that staying on my Humira is best for me and for baby.

Without studies that indicate how babies in utero respond to medication exposures we would be in the dark about what is best for mom and baby not only during pregnancy, but with breastfeeding.

“There is so much misinformation about pregnancy and IBD including being told not to conceive at all or to stop medication. This is incorrect and dangerous. PIANO was started to provide reliable data for women with IBD considering pregnancy so they and their providers can make an informed choice for themselves and their babies,” said Dr. Mahadevan. “Every pregnant woman with IBD has benefited from the generosity of PIANO moms who contributed their outcomes, good or bad, to the pool of knowledge we have. Every PIANO mom who contributes benefits not herself, but future mothers with IBD. It is an invaluable and precious gift.”

What PIANO measures

There are four main areas the PIANO study looks at:

  1. Whether the level of biologic drug transferred across the placenta to the infant by the time of birth predicts the risk of infection or other adverse outcomes
  2. Whether the achievement of developmental milestones is affected by medication exposure
  3. Whether the rates of birth defects, adverse pregnancy outcomes and complications of labor and delivery are affected by IBD medications
  4. Whether second trimester drug levels can be used to adjust drug and minimize transfer across the placenta to the baby

Since I am just now reaching the halfway point of my pregnancy, I have only had to fill out questionnaires. You are required to do so during each trimester, at the end of your pregnancy, and then at 4, 9, and 12 months post-delivery. Along with that, you can provide follow up until your child is 18, once a year. During this trimester I will also provide blood work and a fecal calprotectin. On delivery day, bloodwork will be taken from me, my baby, and my umbilical cord. Depending on my son’s blood work at delivery, I may be asked for more when he’s 3 and 6 months. If at any time I am not comfortable with him getting his blood drawn, I can always opt out. The cord blood is similar to the baby blood at birth so that is adequate. I can also choose to stop the annual questionnaire at any time.

If a woman receives the COVID-19 vaccine during pregnancy, the PIANO study is also measuring the antibody levels found in the cord blood (on the day of birth) to confirm that the benefit transfers to the baby. Breastmilk will also be measured for the transfer of protective antibody against COVID.

The Findings Thus Far

In a presentation this past fall, Dr. Mahadevan shared findings from PIANO.

“We looked at pregnancy, birth and developmental outcomes in the infants at one year, based on exposure to drug, and found no increase in negative outcomes and no reduction in developmental milestones. Biologic‑exposed infants did have some statistically increased improvement in developmental milestones compared to the unexposed group. Overall, what this study suggests is that women with inflammatory bowel disease should continue their biologics and thiopurines throughout pregnancy to maintain remission, given no evidence of harm, and evidence that  disease activity can increase miscarriage.”

The study also found that disease activity can increase preterm labor and birth, all the more reason for women to stay on their medication and not try and go med-free while pregnant.

Looking to the Future

Currently, there is no end date for the study. As long as there is funding, the project will continue. Dr. Mahadevan says with all the new medications coming down the pipeline there is a need for safety data. She says, “The infrastructure of PIANO allows us to study new medications as they come to market, even before they are approved for IBD.”

To participate in the study women must have IBD and live in the United States. Interested in learning more or getting enrolled? Email PIANO@ucsf.edu or call 415-885-3734.

Celebrating a major patient victory: Citrate-free Humira

I still remember the first time I felt the pain. Sitting in my GI’s office with the nurse and my mom. Fresh out of the hospital after having an abscess the size of a tennis ball in my small intestine. Knowing I had to inject myself with a painful biologic drug, four times in a row, for the loading dose. The feeling when the medication entered my body was like nothing I had ever felt before. It was an unthinkable amount of pain. It was overwhelming knowing that for the rest of my life, I would endure this same pain, multiple times a month…with no end in sight.

Fast forward more than ten years later. A total of 122 months, hundreds of injections. My reality as a Crohn’s patient just changed. IMG_2966It changed in a way that I never knew was possible. I have so many flashbacks of my journey with Humira. The tears as I felt sickly in my 20s sitting alone in my apartment and wondering why me. The dread, anxiety and anticipation every other Monday and the strength I had to muster up within myself to once again receive my medication. Holding the injection in my hand, getting in the zone and focusing my thoughts on brave family members and friends as I held down the plum colored button and felt the burn. The sad look on my son’s face as he looked in my eyes and witnessed his mama hurting.

Now, all this is a distant memory. Thanks to the Citrate-free formula developed by AbbVie and approved for adults and pediatric patients in the United States, this reality is over. A matter of days ago, I experienced my first pain free Humira injection. I had heard all the hype and excitement around it, but it was so difficult to fathom such a change in my patient experience. Here’s a video of me experiencing my first Citrate-free injection:

I’m here to tell you it’s completely painless. Less pain than a blood draw. Less than a flu shot. You feel nothing. The process, effectiveness and outcome are the same, but you don’t feel anything. It’s emotional and overwhelming in the best way. I cried for a good half hour after my first one, happy tears. Tears of joy from a woman who now knows her children will never see their mom struggle in pain. Tears of joy from someone whose eternally grateful for a medication that keeps a painful and debilitating chronic illness at bay. Tears of joy knowing that I will never have to feel that awful pain again. A pain that’s too much to put into words, that was part of my life for so long.

The sun is shining a bit brighter today. I feel a load has been lifted off my shoulders that I didn’t even realize had been there for more than 10 years. When I heard about the Citrate-free formula being approved and available in the States, I was excited—but, didn’t realize the true extent of what a difference it would make in my life. joy-2483926_1920

If you’re on Humira and living in the States, make sure you talk with your GI and specialty pharmacy to ensure your script is changed to “Citrate-free”. The extra leg work will be so worth it. It brings me so much happiness to know that young children on Humira will never have to feel the pain. It gives me peace of mind as a chronic illness patient to know that developments like this in treatment are possible and happening right now.

My call of action to doctors, specialists, healthcare teams and specialty pharmacies—please communicate this with patients. I’ve heard from countless people around the United States who heard about this for the first time from me. That’s not the way it should be. My GI gave me a heads up three months ago.

Fellow patient advocates, please feel empowered to share what this means to you and reach out to your individual communities and support networks, so people can get the ball rolling and experience this for themselves. Our voices are strong, and word of mouth is powerful.

Humira was approved for Crohn’s in 2006. I started taking the injections in 2008. Now, it’s 2018 and patients in the United States have access to the Citrate-free (pain free) formula. What’s next? Now, we can truly continue to dream.

Finding “Hope” and grace through motherhood and IBD

Connecting with women who battle inflammatory bowel disease and juggle it all is empowering. When I came across Hope (@hopeheartandhome) on Instagram, I was immediately impressed by her upbeat, real-life look at life as a stay at home, wife and as a blogger. Weeks passed by—and she mentioned she had Crohn’s disease in her in Insta-story. I sent her a direct message because there’s so much we can learn from one another as we navigate motherhood and life in general with inflammatory bowel disease. IMG_2070 (1)I specifically was interested in featuring Hope because she’s pregnant with baby #2!

Hope is 28 and lives in Charlotte, North Carolina with her husband and two-year-old daughter, Evie. She’s due with her second baby this October. August marks 10 years since she was diagnosed with Crohn’s disease. In getting to know Hope, her name fits her to a T. She is inspiring, driven, funny and focused on living her best life—despite her disease.

Like many of us, Hope was young when she received the life-changing diagnosis. At only 17—she had her entire future before her. In November 2012, after numerous hospital stays and an abscess that would not go away with IV meds, she had surgery to remove her ileum. Unfortunately, post-surgery she faced several complications ranging from a pinhole leak, surgery to repair the leak, as well as a serious case of MRSA. Hope says thanks to her faith in Christ and the support of family and friends, she came out stronger than ever with a 7-inch battle scar to prove it! Hope has been taking Cimzia injections ever since and has been able to maintain remission.

As a woman with IBD–did your Crohn’s present any complications or issues along the way with your first pregnancy?

Hope: “I answer this with an insanely grateful NO! I am extremely blessed that my body reacts so well to pregnancy. In fact, my gastro doctor often teases me that I need to have alllll the babies because my body loves being pregnant. I say this with sensitivity, as I know it is a struggle for many women and due to surgery IMG_1446complications, the doctors I saw were pretty sure I would have difficulty conceiving; however, I am so thankful that God has given me grace in that aspect of my life. I will say that my first pregnancy was a bit of an “oops”, BUT my body was in 100% remission and I believe that greatly contributed to my success. This time around—knowing that I wanted to get pregnant, I made appointments with my GI and had blood-work, a colonoscopy, and wound up having to have an MRI to rule out any potential flare up. Thankfully, I was flare free and my doctor gave us the “ok” to try and conceive. I attribute much of our success to my remission. A healthy mom has a much greater chance of conceiving successfully in terms of Crohn’s Disease.”

How has Crohn’s impacted your role as a mom and a wife?

Hope: “Wow. This a big question! I’ve honestly never really thought about it impacting these roles of mine. I see Crohn’s as a little portion of who I am. It’s a very unglamorous and annoying part of me that I don’t like…but, it’s a part of me and therefore my story. Truthfully, I have been so blessed to have been in remission for about four solid years now, so my roles of wife/mom haven’t been altered by it, and for that I am extremely grateful. It was a long and bumpy road to get here and I would be lying if I said the thought of having a flare up doesn’t terrify me. IMG_1914It definitely does, BUT I try to live my life with as much positivity as I can and a lot of laughter. I’ve found that Crohn’s has matured me far beyond my age in years and that has helped me navigate the endless responsibilities that come with being a young wife and a young mother. I never take health for granted and I am thankful every day for the opportunity to raise my child(ren) free of feeling sick. I get fatigued faster than the average person due to Crohn’s, but I am so used to it, it’s my normal. Also, have you ever met a mom who is full of endless energy?! Nope.”

Now you’re pregnant with baby #2, first of all HUGE congrats! How has this pregnancy compared to your first one–how are you feeling in comparison, etc.?

Hope: “Crohn’s-wise I feel wonderful and am experiencing zero symptoms. Pregnancy wise I am much more exhausted this time around thanks to my full of energy little two-year-old! Second pregnancies are very different… the “newness” is gone, and you know what to expect and I haven’t had a minute to daydream about this baby as often as I did with my daughter, but that’s because she keeps me busy! We’re excited to see if a little boy or another little girl will be joining us this fall!”

What advice do you have for women with chronic illness who aspire to be moms themselves?

Hope: “Patience and prayer. God hears our every thought and I truly believe He desires to give us the desires of our own hearts. The biggest thing I have learned in my life as a Crohn’s girl is that our timing is not our own. IMG_2023We must surrender to Christ and let him lead us through the highs and the lows. If you aren’t a person of faith, my prayer for you is that you find peace in either the waiting of becoming a mom or peace in the journey of motherhood. It is not easy at all, but it is so worth it, and I pray for every woman who might be struggling to carry a baby because of this disease. It truly breaks my heart to think about that suffering. When I was pregnant with Evie, I joined a study called the PIANO study which stands for Pregnancy and Neonatal Outcomes in Women with Inflammatory Bowel Disease I answered questions during pregnancy and at birth I brought in a lab kit where we sent off blood from me, from Evie, and from my umbilical cord, to study if any of my medications got to my baby. There was no trace of Cimzia in Evie’s blood or the umbilical cord which was wonderful and a big part of why I take Cimzia, as it does not pass the placenta. But, I mention this study to share my passion to help all women with IBD reach their dream of motherhood. I crave more information about this disease specifically for those moms struggling. Know that you’re not alone and you have many people rooting for you and your future babies!”

How do you find time to focus on self-care and combat the fatigue associated with not only motherhood, but IBD?

Hope: “I have not mastered this at all, but I am trying. Working out is something I do for me…my 45 minutes of endorphins, alone time, and knowing I am fueling my body. Open communication with my husband is another thing that helps me focus on self-care. If I am feeling exhausted or just needing some time, I tell him. We must communicate on how I am feeling to fully be a team. And hey, same goes for him! I’ve learned a lot about friendships/relationships and making sure that I set my time and energy on things and in people who are truly rooting for me and my family and vice versa. Life is too short to spend it stressed out or surrounded by people who are not life-giving. That’s been a hard lesson for my people pleasing self, but, being strong in my beliefs and in who I am and what I want to put out into this world has helped my mindset and overall health tremendously.”

Tell me about your blog Hope Heart and Home. With more than 11,200 Instagram followers you must keep busy! What inspired you to start the blog? 

Hope: “This blog was originally started by my sister and I actually had my own blog, but once image1 (10)Evie was born, my blog kind of fizzled and after awhile I was missing that creative outlet. My sister was pregnant with her second at the time and we decided to join forces and it was so much fun for us! Recently, my sister has taken a step back from blogging and is pursuing different passion and focusing solely on her family, so the blog has evolved again into an outlet for me. I am an extrovert and love talking with new people/sharing recipes/getting advice/looking at the newest trends/home decor/etc. so blogging just seems like a good fit for my personality. I am a stay at home mommy first and foremost, but the blog has allowed me to have something else that’s just mine and just for me.”

Interested in connecting with Hope? You can do so by emailing her at: hopeheartandhome@gmail.com or following her on Instagram (@hopeheartandhome).