Dazodalibep vs. Nipocalimab: Patient Perspectives on Sjogren's Clinical Trials
I'm thrilled to share a candid conversation with one of our community members, Janet Steins, about the personal, lived experiences of participating in Sjogren's clinical trials. There's often a bit of mystery and even fear around clinical trials, and our goal today is to pull back the curtain and make the process feel less foreign and scary.
Janet, who lives in Northwest Missouri, was diagnosed with Sjogren's Disease in 2021. She found an incredible rheumatologist (Dr. Tina Shah in Kansas City, an hour's drive away) who eventually became her trial doctor – a true blessing!
Why Join a Clinical Trial? Janet's "Aha!" Moment
Janet shared that her rheumatologist approached her about the Dazodalibep trial, telling her, "Janet, you're probably my number one candidate." At 57, after trying various medications like hydroxychloroquine (which caused side effects) and methotrexate without significant relief, Janet’s thought was, "What do I have to lose?" She dove deep into the research, saw promising early results, and felt compelled to contribute to the Sjogren's community.
"No one understands Sjogren's," Janet explained. "There's not much research on Sjogren's... I was very interested in it." This resonated deeply with me. Sjogren's is the most common autoimmune disease no one has heard about, and actively participating in research offers profound hope.
The Trial Journey: Hurdles, Hope, and Healing
Getting into a clinical trial can involve hurdles. Janet initially had a false positive TB test and was temporarily kicked out! Her doctor tirelessly advocated for her for two months until she was allowed to retest and eventually enroll in the Dazodalibep (OASIZ) trial in August.
Then came the first infusion. Janet admits she thought she probably received the placebo. But that night, everything changed. "I have saliva," she told her husband. "I can spit! I never knew what it was like!" Her energy started coming back, too. These unexpected improvements were monumental.
The Screening and Enrollment Process
The screening process typically involves:
Initial Contact: Often through ClinicalTrials.gov, Sjogren's Foundation newsletters, or (like Janet) directly from your physician.
Detailed Screening: Comprehensive blood tests (sometimes a dozen or more tubes!), chest X-rays, EKGs, salivary flow tests, and (my least favorite part!) Schirmer’s tests for dry eye. Janet even opted out of the Schirmer's test due to discomfort – it's crucial to remember you have the right to do so!
Daily Surveys: Participants often complete daily surveys on an app, rating symptom severity, energy, and pain. These must be completed by midnight, even when you're on vacation (Janet shared a funny story about trying to find Wi-Fi on an Alaskan cruise!).
Trial Design: Dazodalibep vs. Nipocalimab & More
Janet and I are both in the Phase 3 OASIZ trial for Dazodalibep. There are at least two other promising medications in advanced trials:
Nipocalimab: Also an infusion, recently received FDA Fast Track and Breakthrough Therapy designations.
Efgartigimod: An injection, currently approved for myasthenia gravis and now being studied in Sjogren's. Interestingly, this drug can be self-administered at home, offering more flexibility for some patients.
Clinical trials typically have three phases:
Phase 1: Small groups, focused on safety.
Phase 2: Larger groups, focused on effectiveness and optimal dosage.
Phase 3: Even larger groups, confirming effectiveness and safety before FDA review.
Trials have strict inclusion/exclusion criteria to gather "cleaner" data for FDA approval. This means seronegative Sjogren's patients (those without positive SS-A/SS-B antibodies) are often excluded from initial trials – a frustrating reality that highlights the need for more diverse trial arms. (To all the pharmaceutical companies listening: We need seronegative trials!)
The Personal Impact: More Than Just a Drug
Janet’s participation profoundly changed her view of her health. She went off other medications (methotrexate, gabapentin) with her doctor’s blessing due to significant improvement. "I have no joint pain," she exclaimed, recalling how she could hardly walk before her diagnosis. Her dentist noticed a significant increase in saliva, and food "tastes better" now that she has more saliva – something she never even knew she was missing!
Her experience highlights how Sjogren's can masquerade as other conditions. Years ago, she was diagnosed with interstitial cystitis (IC) and did the elimination diet, only to now realize it was likely Sjogren’s all along. "Sjogren's attacks anything with fluid," she noted, realizing her bladder issues were connected. This underscores how Sjogren's affects multiple body systems, impacting everything from gut permeability to widespread allergic reactions (celiac disease, gluten issues, drug allergies, skin allergies, sinus issues).
Considering a Clinical Trial? Janet's Advice: "Go For It!"
Janet's advice for anyone considering a clinical trial: "Don't second guess yourself. Go for it!"
Her trust in her doctor, who advocated fiercely to get her back into the trial, made all the difference. She shared that the time commitment (a monthly, day-long visit for infusions) feels like an "investment in my life," not a burden, because she feels so much better. The stipend she receives (my "mad money" for takeout on infusion days!) is just a bonus.
Despite the initial fear of needles and extensive blood draws, Janet now views it as a profound connection to someone she may never know, and a way to help others. "You're not only helping yourself in the future, you're helping other people in the future," she wisely concluded.
The Evolution of Medicine: Past, Present, and Future
Our conversation reflected on how much medicine has changed. We reminisced about our parents’ generation and doctors who smoked cigars in the office! While modern medicine offers incredible diagnostic tools (like that "OpenEvidence" AI tab I keep open to quickly access medical journals and references!), we've sometimes lost the art of deep listening and clinical nuance that older physicians embodied. We need to find that balance again.
Join Our Community: You Are Not Alone!
If you're grappling with a Sjogren's diagnosis, especially if you're seronegative and feeling unheard, remember Janet's story. These trials, though rigorous, offer immense hope.
What questions do you have about clinical trials? What's your personal takeaway from Janet's story? Share your thoughts in the comments below!
Join our free Facebook group, the Success with Sjogren’s Sisterhood (all genders welcome – it’s about the spirit of sisterhood!), for connection and support. And explore my telehealth practice, the Immune Confident Institute, for personalized care! (Links below!)
