Endometriosis: looking back, demanding better

If you want to know what life with endometriosis is like, find a group of 10 women and ask. At least one of them will be able to tell you all about it.

This woman might tell you about the first time she vomited from the pain at the age of 13, and her parents brought her to the emergency room fearing appendicitis. How it took a full year to realize the episodes of severe cramps weren’t random stomach aches, but something that happened every 28 days.

She might tell you about the laparoscopy she had at 18; how her school attendance suffered; how later, multiple miscarriages and difficult pregnancies solidified her belief that her body was damaged.

She might tell you all of this, but she probably won’t, because she’s tired of rehashing it; she’s sick of being told that it’s just a painful period. Instead, she accepts the pain from endometriosis as a constant companion, like so many women before her.

Endometriosis occurs when tissue that acts a lot like the lining of the uterus—called endometrium—starts growing outside of the uterus. This tissue forms lesions or implants that attach to the ovaries, bladder, fallopian tubes, bowel and other areas near the uterus, causing inflammation and severe pelvic pain, pain with periods, and pain during intercourse.⁽¹⁾

The operative word here is pain, and not just the physical kind. Not only is there currently no cure for endometriosis, but it can take up to 10 years for a woman to get a proper diagnosis. The most common way to definitively diagnose endometriosis is through a surgical procedure called a laparoscopy, where a tiny camera (inserted through small incisions in the abdomen) helps surgeons discover hidden, renegade tissue. The endometrial lesions can be excised during the same surgery, but it’s not curative; many women require medical or surgical retreatment within two years after surgery.

Considering all of this, you’d think society would prioritize better research, treatment options and diagnostic criteria for such a prevalent, chronic condition. Unfortunately, there have been very few advancements in endometriosis care in decades.⁽³⁾

“There’s been a neglect of women in this area,” says Marianne Sutcliffe, vice president, women’s health, AbbVie. “There hasn’t been enough investment or emphasis on endometriosis, and there’s not the support that these women need.”

Sutcliffe wonders if this is partially due to societal expectations of women.

“I think as women, we suffer and muddle through it, because that’s what people expect us to do,” she says. “Women are out there suffering on their own, going from doctor to doctor trying to get answers, and not only is it frustrating, but the pain is impacting their lives – their social lives, their time with their families, and their ability to go to school or work.”

Dawn Carlson, vice president, general medicine, AbbVie, agrees. Now leading the AbbVie team striving to find treatments for endometriosis, she previously worked to bring medicines to market in the areas of immunology and oncology.

Ask her about her current role, and she’ll tell you about the disparities inherent in women’s health, the stigma of talking about a reproductive condition, the fact that medicine had long considered endometriosis a “surgical disease,” and – mostly disturbingly for Carlson – that women often feel their endometriosis-related pain isn’t taken seriously.

“I met a patient who had really heavy bleeding. She’d been told that unless she passed clots larger than her head, it was nothing to worry about. When she finally had (investigative laparoscopic) surgery, and she woke up and was told she had endometriosis, she was actually happy because that meant she wasn’t crazy, and someone believed her,” Carlson says.

Under Carlson’s leadership, a group of Illinois-based scientists, physicians, clinical trial specialists and more have been working to change the status quo for endometriosis and related conditions.

Their journey began eight years ago and a thousand miles west, when a California-based biotech called Neurocrine Biosciences found itself with a novel compound and the need for a clinical partner to help turn it into a medicine.

The company had ample data showing the promise of their compound for the treatment of endometriosis-related pain, but needed a partner for the large-scale development program they felt the compound deserved. AbbVie was looking to expand its endocrinology business and hone in on unmet needs in women’s health.

“Neurocrine Biosciences came to us with some incredibly innovative ideas about the potential of this medicine… [and] it was our job to make these possibilities a reality,” Carlson says.

One of the first steps in designing a clinical program for a new medication is developing the endpoints – the primary outcomes measured by a clinical trial, used to show the value the medication might bring to patients, physicians and other stakeholders. These endpoints are often straightforward; for example, lower levels of disease in the blood, number of episodes, or clearance of lesions.

But developing endpoints for a medication used to treat endometriosis is a different animal altogether, says Ahmed Soliman, associate director, Health Economics and Outcomes Research (HEOR), AbbVie, who works with Carlson on the women’s health team.

This is a disease where everything is patient reported. We do measure estrogen levels but what really matters is the pain that patients report,” he explains. “We also wanted to measure how that pain impacts multiple dimensions of someone’s quality of life and productivity.”

Neurocrine Biosciences had developed endpoints to use in this clinical program, with guidance from the U.S. Food and Drug Administration (FDA). AbbVie’s HEOR team used these as a starting point, speaking with patients to ensure that their clinical program reflected the needs of those affected by endometriosis. The result of these combined efforts was a series of rigorous primary and secondary endpoints that spoke to several types of endometriosis-related pain, quality of life, productivity, health care utilization and fatigue.

During this process, Soliman and his HEOR colleagues were made acutely aware of the delay in diagnosis that so many women experienced. They found that a number of surveys had been developed to assist clinicians in identifying patients, but felt these were too long, or too complicated.

So, in addition to developing the endpoints for AbbVie’s clinical trials, the HEOR team worked with physicians and endometriosis patients to create a short questionnaire that could help facilitate patient-clinician conversations about endometriosis.

“Part of our job is to quantify the disease burden on patients for any given condition, and see how a new therapy of treatment could alleviate that burden,” Soliman says. “And taking 10 years to get a diagnosis is a significant burden, on top of the more obvious burden of the disease itself. Reducing this burden isn’t just about reducing pain or developing new medicines. It’s beyond that.”

That “beyond” that Soliman notes means understanding the lived reality of women with endometriosis – and to do that, you need to hear from to those women.

You probably won’t need to look very far to find them. There’s been a growing roar breaking through the many years of stagnant progress in women’s health.

“When we started studying the potential indications for our compound back in the early 2000’s, you never heard anything about endometriosis,” recalls Kevin Gorman, CEO, Neurocrine Biosciences. “I would talk to friends and family members about our work, though, and lights would go off in their heads. They would say, ‘that's me. I curl up in bed for three days out of every month in agonizing pain, but my mom did too, so I've always been taught that this is normal.’”

“All I did was start talking about endometriosis, and I found the one in 10 right in front of me,” Sutcliffe says. “There were several women on my team alone who have the condition; I’d bet we all know someone – a sister, a friend, a coworker – with endometriosis, but yet there is very little dialogue about it. It’s time for a revolution, where we put this women’s health disease on the map, and provide tools that were never there before for patients or the physicians who are doing their best to treat them with such limited options.”

Carlson has also noticed an increase in attention and research for endometriosis – which she believes is long overdue.

“We’re finally getting somewhere now where we can make a difference,” she says. “Even if all our work does is help awareness so that this is something women talk about – and most importantly, are listened to – then it would be worth it.”