There’s a moment every person with Crohn’s disease knows intimately—when you’re sitting in your doctor’s office, having tried treatment after treatment, and the conversation turns to “what’s next.” For many in our community, that conversation has become increasingly difficult as traditional therapies fail to provide the relief we desperately need. The weight of living with uncontrolled symptoms while running out of treatment options can feel overwhelming.

But sometimes, hope arrives in the form of scientific progress. For those who have felt stuck in this cycle of failed treatments, recent news from the FDA brings a new possibility to the table—one that could change the trajectory of their Crohn’s journey.

Summary of FDA Approves AbbVie’s Rinvoq for Crohn’s Disease

On June 28, 2023, the FDA approved Rinvoq (upadacitinib) for treating moderate to severe Crohn’s disease, marking a significant milestone for patients who have struggled with traditional treatments. This oral medication, manufactured by AbbVie, was already being used successfully for other autoimmune conditions like rheumatoid arthritis.

The approval was based on clinical trials that specifically focused on patients who had little or no success with previous therapies—particularly those who didn’t respond well to anti-TNF biologics or couldn’t tolerate them. The studies showed that Rinvoq not only provided rapid symptom relief but also helped maintain long-term remission for many participants.

Rinvoq works as a JAK (Janus kinase) inhibitor, targeting specific immune system pathways that drive inflammation in Crohn’s disease. By blocking these pathways, the medication can reduce the underlying immune responses causing painful symptoms. However, the approval comes with important safety warnings about potential risks including infections, blood clots, and certain cancers, requiring careful evaluation by patients and their healthcare teams.

This post summarizes reporting from FDA Approves AbbVie’s Rinvoq for Crohn’s Disease. Our analysis represents IBD Movement’s perspective and is intended to help patients understand how this news may affect them. Read the original article for complete details.

What This Means for the IBD Community

This approval represents more than just another medication option—it’s a lifeline for a specific group of Crohn’s patients who have been living in a particularly challenging space. If you’ve been through multiple biologics without success, or if you’ve experienced intolerable side effects that forced you to discontinue treatment, you know the frustration of feeling like you’re running out of choices.

What makes this approval especially meaningful is that Rinvoq specifically targets patients who haven’t responded to anti-TNF therapies. In the IBD world, we often talk about “treatment failure,” but it’s important to understand that when a treatment doesn’t work, it doesn’t mean you’ve failed—it means we need different tools. Rinvoq represents one of those different tools, using a completely different mechanism of action than TNF inhibitors.

The oral format is another game-changer worth considering. Many of us in the Crohn’s community have complex relationships with infusion centers, injection schedules, and the logistics of biologic therapies. An oral medication can offer more flexibility and autonomy in managing your treatment routine. No more planning your life around infusion appointments or dealing with injection site reactions.

From a practical standpoint, this approval could mean fewer emergency room visits, more predictable days, and the possibility of participating more fully in work, relationships, and activities that severe Crohn’s symptoms have limited. The studies showed not just symptom improvement, but sustained remission—meaning the potential for longer stretches of feeling well.

Questions to Discuss with Your Healthcare Team

If you’re someone who has struggled with anti-TNF therapies, this news likely has you wondering whether Rinvoq might be right for you. Here are some important questions to bring to your next appointment:

• Given my treatment history and current disease activity, could I be a candidate for Rinvoq?
• How do the risks and benefits of Rinvoq compare to continuing my current treatment approach?
• What monitoring would be required if I started this medication?
• How might this affect other medications I’m taking or health conditions I have?
• What should I expect in terms of timeline for seeing improvements?
• How does the cost and insurance coverage compare to my current treatment?

Remember, the safety warnings mentioned in the approval are serious and require honest discussion. Your doctor needs to know your complete health history, including any previous infections, blood clot risks, or family history of cancer. The goal is finding the treatment approach that offers the best balance of effectiveness and safety for your unique situation.

The Bigger Picture for IBD Research

This approval fits into a broader trend we’re seeing in IBD treatment—the recognition that different patients need different approaches, and that targeting various pathways in the immune system can provide options when traditional treatments fall short. The JAK inhibitor class represents a different way of thinking about inflammation control, and Rinvoq’s success in Crohn’s disease adds to growing evidence that precision medicine approaches are the future of IBD care.

What’s particularly encouraging is that this approval was based on studies of patients who had already tried and struggled with other treatments. Too often, breakthrough therapies are tested primarily in treatment-naive patients, leaving those of us with complex treatment histories wondering if new options will actually help. Rinvoq’s approval specifically addresses the needs of patients who have been through the treatment maze without success.

This also represents the ongoing evolution of how we understand Crohn’s disease itself. As researchers identify different inflammatory pathways and immune system targets, we’re moving away from a one-size-fits-all approach toward more personalized treatment strategies. Each new mechanism of action approved gives us more tools to find the right fit for individual patients.

Hope Grounded in Science

It’s worth acknowledging that living with treatment-resistant Crohn’s disease can feel isolating and discouraging. When you’ve tried multiple therapies without achieving the relief you need, it’s natural to wonder if anything will ever work. This approval reminds us that pharmaceutical research continues to advance, and that the scientific community recognizes the urgent need for options for patients who haven’t found success with existing treatments.

The clinical trial results showing both rapid relief and sustained remission are particularly meaningful because they address two key challenges many of us face: getting symptoms under control quickly enough to resume normal life, and maintaining that control over time. The combination of these outcomes in patients with refractory disease represents real progress in addressing unmet medical needs.

While Rinvoq isn’t a cure, and it won’t be the right choice for everyone, its approval expands the toolkit available to gastroenterologists and gives hope to patients who may have felt stuck. In the complex landscape of IBD treatment, having more scientifically-backed options means more opportunities to find an approach that works for your unique situation.

This approval also validates the experiences of patients who have struggled with traditional treatments. Your challenges with existing therapies aren’t a personal failure—they’re a medical reality that researchers and pharmaceutical companies are actively working to address. Each new approval like this one represents recognition of those challenges and commitment to finding solutions.

The road ahead still requires careful collaboration with your healthcare team, honest assessment of risks and benefits, and patience as you potentially explore this new option. But for the first time in a while, there’s a new door to try opening—one specifically designed for patients who have found other doors locked. In the journey of managing Crohn’s disease, having that new possibility can make all the difference in maintaining hope and continuing to fight for better days ahead.

IBD Movement provides information for educational purposes only. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition.