Tim Smith joined the MJH Life Sciences team in 2022 and is currently an associate editor for HCPLive. He is also the executive producer of two podcasts: Skin of Color Savvy and The Medical Sisterhood. Previously, he was the producer of the Lungcast podcast. He graduated from UC Berkeley and worked in multimedia journalism as a staff writer prior to joining MJH. You can contact him at tsmith@mjhlifesciences.com.

Bimekizumab therapy for individuals with 

 may improve patient-reported outcomes (PROs) and health-related quality of life as early as 4 weeks and through 3 years of use, new data suggest.

These findings on bimekizumab’s use in psoriasis were authored by such investigators as Matthias Augustin, MD, PhD, of the University Medical Center Hamburg-Eppendorf’s Institute for Health Services Research in Dermatology and Nursing (IVDP), and published in 

. According to Augustin et al, the BE RADIANT study was the first phase 3 analysis to evaluate dual inhibition of interleulin (IL)-17F and IL-17A versus IL-17A alone, by making a comparison of the impact and safety of bimekizumab with secukinumab.

“Herein, we report an in-depth post hoc analysis of short- and long-term PROs, as well as concurrent achievement of clinical and health-related quality of life outcomes, in patients with moderate to severe plaque psoriasis from the BE RADIANT phase 3b trial,” Augustin and coauthors wrote.

The investigative team highlighted several key facts about the BE RADIANT study, noting the multicenter, phase 3, randomized clinical trial also involved an open-label extension (OLE). It was made up a 48-week double-blind treatment period followed by a 96-week OLE, with a total of 3 years of therapy being included. Those assessed were initially assigned to be treated either with bimekizumab or secukinumab. At the 48-week mark, during entry into the OLE, subjects originally randomized to bimekizumab continued the same therapy (continuous bimekizumab cohort). Meanwhile, those assigned to secukinumab shifted to bimekizumab (secukinumab/bimekizumab cohort).

Outcomes included patient-reported skin pain, pruritus, and scaling symptoms, evaluated via the Psoriasis Symptoms and Impacts Measure (P-SIM). Additionally, the investigators looked at rates of complete skin clearance (Psoriasis Area and Severity Index [PASI] = 0) achievement and minimal quality-of-life impact (Dermatology Life Quality Index [DLQI] 0/1) attainment. Efficacy through the 1-year mark was assessed via nonresponder imputation, and data from years 1 - 3 were assessed via modified nonresponder imputation.

Those involved in the continuous bimekizumab arm were given 320 mg every 4 weeks through Week 16, and this was followed by dosing every 4 or 8 weeks through the first year and into the OLE period. Subjects initially treated with secukinumab received 300 mg every 4 weeks through Year 1, after which they shifted to bimekizumab 320 mg every 4 or 8 weeks. By the 64-week mark, all subjects were on bimekizumab, administered every 8 weeks. At the point of baseline, 373 individuals were randomized to bimekizumab and 370 to secukinumab; 336 and 318 individuals, respectively, were entered into the OLE.

How Effective is Bimekizumab for Psoriasis?

By the 4-week mark, Augustin and colleagues noted a greater proportion of those in the bimekizumab group saw a complete resolution of their symptoms compared with those on secukinumab.

Specifically, the team observed the absence of itching by 34.0% of those in the bimekizumab arm versus 25.1% of those in the secukinumab arm; a lack of skin pain was noted among 74.5% versus 222 60.0%; and a lack of scaling by 46.1% versus 21.6%, respectively.

Such differences persisted through the 1-year mark. Pruritus was still absent in 60.9% of those on bimekizumab versus 48.1% of those on secukinumab (nominal 

 < .001). In a similar set of findings, Augustin et al found 78.6% versus 70.8% had no skin pain (nominal 

 = .01), and 70.5% versus 49.7% saw no scaling (nominal 

Simultaneous PASI = 0 and DLQI 0/1 attainment was also observed by the investigative team more commonly among the bimekizumab cohort. At the 4-week mark, 11.5% in the bimekizumab group were shown to have achieved both endpoints compared with 4.6% in the secukinumab cohort (nominal 

 < .001). By the 1-year mark, such rates rose to 61.7% versus 42.7%, respectively (nominal 

 < .001). Among the individuals entered into the OLE, the high rates of complete symptom resolution on the P-SIM (score = 0) were sustained through the 3-year mark.

By the OLE’s initiation, concurrent PASI = 0 and DLQI 0/1 responses were noted by the investigators among 69.2% of continuous bimekizumab-treated individuals and 48.5% of individuals switching from secukinumab. Following the transition to bimekizumab, the response rates in the secukinumab/bimekizumab arm were noted to have improved. Additionally, by Year 3, similarly high proportions were maintained in both the continuous bimekizumab group and the switch group (62.2% and 63.8%, respectively).

“Many patients treated with bimekizumab had concurrent improvements in clinical outcomes and PROs, both of which are important for informing treatment decisions, suggesting that bimekizumab’s high clinical efficacy translates into benefits to patient-perceived symptoms and health-related quality of life,” the team concluded.

Augustin M, Feldman SR, Warren RB, et al. Three-Year Patient-Reported Outcomes From Bimekizumab for Plaque Psoriasis: The BE RADIANT Randomized Clinical Trial With Open-Label Extension. JAMA Dermatol. Published online February 18, 2026. 

Reich K, Warren RB, Blauvelt A. Bimekizumab versus Secukinumab in Plaque Psoriasis. N Engl J Med. 2021 Jul 8;385(2):142-152. 

Articles

Dual IL-17A/IL-17F blockade with bimekizumab produced rapid, clinically meaningful improvements in plaque psoriasis symptoms and health-related quality of life versus IL-17A inhibition alone. In BE RADIANT, patient-reported pruritus, skin pain, and scaling improved by Week 4 and differences versus secukinumab persisted through Year 1. Across the open-label extension, symptom resolution on P-SIM and concurrent complete clearance (PASI 0) with minimal QoL impact (DLQI 0/1) were sustained through 3 years. Switching from secukinumab to bimekizumab improved composite outcomes.

In the phase 3b BE RADIANT trial and its open-label extension, bimekizumab treatment led to durable improvements in patient-reported outcomes over 3 years.

Plaque Psoriasis

The HCPLive plaque psoriasis page is a resource for medical news and expert insights on psoriasis. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for psoriatic disease, and more.

News

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Clinical

clinical page is a resource for content on every specialty, disease, and topic available on our medical news site.

BE RADIANT Trial: Bimekizumab Effective for Psoriasis After 3 Years of Use

Justin Ezekowitz, MD, is a professor of medicine at University of Alberta and a cardiologist at the University of Alberta Hospital and Mazankowski Alberta Heart Institute

Sodium Restrictions May Only Benefit Patients at Low Risk of HF, With Justin Ezekowitz, MD

A recent secondary analysis of the SODIUM-HF trial has indicated potential heterogeneity of treatment (HTE) effects from dietary sodium restriction across baseline risk quartiles of patients with or at risk of 

Restriction of dietary sodium is frequently recommended for patients with HF, despite a lack of data explicitly proving the impact of sodium restriction on patient-centered outcomes. SODIUM-HF compared usual care with sodium dietary restriction of <1500 mg/d in patients with HF. Ultimately, the trial was neutral for the primary endpoint of cardiovascular-related hospital admission, cardiovascular-related emergency department visits, or all-cause death.

“What we took away from the overall SODIUM-HF trial was that for some patients, there may be a loosening of recommendations around dietary sodium as an intervention, and that it may, for some patients, improve quality of life,” Justin Ezekowitz, MD, professor of medicine in cardiology at the University of Alberta and co-director of the Canadian VIGOUR Center, told 

 in an exclusive interview. “However, it doesn’t change clinical events, such as cardiovascular death, all-cause mortality, or heart failure hospitalizations. Now, however, when we looked at that in a secondary analysis, we identified that the intervention and its outcomes did vary across different risk quartiles.”

SODIUM-HF was an international, open-label, randomized controlled trial conducted at 26 sites in 6 countries. Enrolled patients were aged ≥18 years with chronic heart failure – defined as New York Heart Association (NYHA) functional class 2-3 – and receiving optimally tolerated guideline-directed medical therapy. Following enrollment, a total of 806 patients were randomly assigned in a 1:1 ratio to either a low-sodium diet (n = 397) or usual care (n = 409).

During the 12-month study period, median sodium intake decreased from 2286 mg/day (interquartile range [IQR] 1653-3005) to 1658 mg/day (1301-2189) in the low sodium group versus 2119 mg/day (1673-2804) to 2073 mg/day (1541-2900) in the usual care group. By month 12, all-cause mortality occurred in 22 patients in the low sodium diet group and 17 in the usual care group (HR, 1.38; 95% CI, 0.73-2.6; 

 = .32), cardiovascular-related hospitalization occurred in 40 patients in the low sodium diet group and 51 patients in the usual care group (HR, 0.82; 95% CI, 0.54-1.24; 

 = .36), and cardiovascular-related emergency department visits occurred in 17 patients in the low sodium diet group and 15 in the usual care group (HR, 1.21; 95% CI, 0.6-2.41; 

Ezekowitz and colleagues utilized the full dataset of SODIUM-HF for the present analysis, including the same 806 patients. The team used a risk-based approach based on the Meta-Analysis Global Group in Chronic (MAGGIC) HF risk score. The quartiles used were 0.036 to 0.102 (low), >0.102 to 0.147 (medium-low), >0.147 to 0.209 (medium-high), and >0.209 to 0.591 (high).

Investigators found strong evidence for the interaction between MAGGIC quartile and intervention, particularly for the medium-low MAGGIC quartile (0.95 probability; % in region of practical equivalence [ROPE] 0.05). Additionally, the primary endpoint – a composite of cardiovascular-related hospital admission, cardiovascular-related emergency department visit, or all-cause death within 12 months – occurred more frequently in the high MAGGIC quartile (probability of benefit of 0.07, %ROPE of 0.05).

Ultimately, despite these results, Ezekowitz and colleagues stated that this analysis should not change practice. However, they call for further research on the effects of sodium restriction in HF, potentially embedding the HTE concept in its design. Ezekowitz also stated that the uniform application of dietary sodium restrictions as an intervention should be reconsidered.

“The largest trial we’ve ever done in this area is, in fact, the SODIUM-HF trial, and it shows that it was neutral for a clinical outcome,” Ezekowitz told 

. “If that is our benchmark for what we implement in clinical practice, then we shouldn’t make broad, sweeping recommendations for all patients now that we recognize that we don’t operate in a vacuum. We should really think about the next trials that need to be done.”

Editor's Note: Ezekowitz reports disclosures with Bayer, Merck, Amgen, Sanofi, Novartis, Cytokinetics, and others.

Zampieri FG, Rathwell S, McAlister FA, et al. Heterogeneity in Treatment Effects in the Reduction of Dietary Sodium to Less Than 100 mmol in Heart Failure (SODIUM-HF): A Secondary Post Hoc Analysis. J Card Fail. 2026;32(2):371-381. 

Ezekowitz JA, Colin-Ramirez E, Ross H, et al. Reduction of dietary sodium to less than 100 mmol in heart failure (SODIUM-HF): an international, open-label, randomised, controlled trial. Lancet. 2022;399(10333):1391-1400. 

Videos

Ezekowitz discusses his recent secondary analysis of the SODIUM-HF trial, highlighting the MAGGIC analysis data that implied a very limited benefit.

Cardiology

Cardiology condition center page is a comprehensive resource for clinical news and insights on cardiovascular and cardiometabolic diseases. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for heart disease and cardiovascular events, as well as associated diabetes, renal failure, and more...

Heart Failure

The HCPLive heart failure page is a resource for medical news and expert insights on HF. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for heart disease, reduced and preserved ejection fraction, and more.

Dual Costimulation Blockade May Eliminate Daily Oral Immunosuppression in Kidney Transplant

A pilot trial evaluating dual costimulatory blockade, dazodalibep + belatecept, may promote immunosuppression adherence and present a non-calcineurin treatment option for kidney transplant recipients.

The phase 2a pilot trial is the first clinical trial to evaluate dual costimulation blockade in humans, with study investigators reporting that a significant number of patients did not require any daily oral medications for 1 year.

“That's never been done,” said Allan Kirk, MD, PhD, a transplant surgeon at Duke Kidney/Transplant Clinic, in an interview with 

 “All immunosuppressive regimens have involved at least some oral medication every single day. And this just showed proof of concept that you could do episodic therapy instead of daily therapy. And I think for patients that's a big plus.”

In a previous interview, we broke down the 

mechanistic rationale and history of targeting the costimulatory pathway with Kirk

Kirk and fellow study investigator concluded the phase 2a, open-label, single-arm, pilot trial to evaluate the efficacy, safety, and tolerability of dual costimulation blockade, dazodalibep and belatacept, in adult recipients of a first, human leukocyte antigen (HLA)–nonidentical kidney allograft from a deceased, living unrelated, or living related donor.

The mean cumulative amount of dazodalibep and belatacept each patient received during the course of the trial was 18,673.9 mg and 6,975.8 mg, respectively.

After administration of dazodalibep and belatacept, patients returned to the transplant center for safety monitoring and costimulation-blockade therapy administration on day 7 and week 2, then every 2 weeks for 5 visits, and then monthly for 9 visits until week 48. All patients were monitored for acute rejection, graft survival, and patient survival through week 48. Patients were followed for a 12-week safety follow-up period after discontinuation of the investigational regimen and conversion to standard-of-care management at the investigator’s discretion.

Investigators deemed the primary endpoint as the incidence of efficacy failure, defined as treated biopsy-proven acute rejection (tBPAR) ≥ grade 1A, graft loss, or death at week 24 after transplantation. The secondary endpoints were the incidence of tBPAR, graft loss, death, or loss to follow-up; incidence of antibody-mediated rejection; incidence of biopsy-proven acute rejection; incidence of treated acute rejections; the proportion of patients with de novo DSAs; as well as the safety and tolerability of dual costimulation. These were evaluated at weeks 12, 24, and 48.

Additional exploratory endpoints included the proportion of patients with estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m2 at weeks 12, 24, and 48. The safety endpoints were treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs).

The trial population included 23 patients, 18 to 70 years of age. Of the 23 enrolled patients who received dazodalibep and belatacept, 13 completed and 10 discontinued the trial. All patients discontinuing either dazodalibep and/or belatacept entered the safety follow-up.

Upon analysis, investigators reported the incidence of composite efficacy failure was 25% (5/20) at weeks 12, 24, and 48. Additionally, there were reversible rejections in patients who received transplants from living related donors (n = 3), a living unrelated donor (n = 1), and a deceased heart-beating donor (n = 1). Overall, they observed 100% graft and patient survival, with 1 patient experiencing delayed graft function.

Investigators did not observe any patients with antibody-mediated rejections, sharing that 30% had treated acute rejections by week 48 (n = 6). Of these, 5 were diagnosed within 12 weeks of transplantation.

The mean (SD) eGFR for all efficacy-evaluable patients at week 48 was 71.3 (12.7) mL/min/1.73 m2 and was similar for patients who did or did not experience an episode of rejection. The percentage of evaluable patients with an eGFR ≥60 mL/min/1.73 m2 was 59%, 74%, and 92% at weeks 12, 24, and 48, respectively.

“This means that people on this approach need to be monitored carefully and early if you catch a rejection, it's easy to reverse,” explained Kirk.

Editor’s Note: Kirk reports relevant disclosures with Ededon Pharmaceuticals.

Vincenti F, Shoji J, Wojciechowski D, et al. Dual costimulation blockade with the CD154-specific fusion protein dazodalibep and belatacept for prophylaxis of kidney allograft rejection. 

https://doi.org/10.1016/j.ajt.2025.12.290

Kirk A, Hillenbrand A. Mechanistic Rationale for Dual Costimulation Blockade, Belatacept, Dazodalibep in Kidney Transplantation. HCPLive. Published February 18, 2026. Accessed February 19, 2026. 

https://www.hcplive.com/view/mechanistic-rationale-for-dual-costimulation-blockade-belatacept-dazodalibep-in-kidney-transplantation

Targeting CD28 and CD154 pathways, dual blockade with belatacept and dazodalibep offers potential to improve adherence in kidney transplant recipients.



Nephrology

The HCPLive nephrology page is a resource for medical news and expert insights on kidney disease. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments in nephrology, and more.

Chelsie Derman is an associate editor for 

who covers psychiatry, sleep medicine, geriatrics, migraine, and allergy. She joined MJH Life Sciences in September 2023 after graduating from The College of New Jersey with a bachelor’s degree in journalism and professional writing. In her free time, she enjoys creative writing and reading.

On February 17, 2026, Compass Pathways announced that its investigational synthetic psilocybin formulation, COMP360, met the primary endpoint in the second pivotal phase 3 trial evaluating the therapy in adults with 

 In the COMP006 study, two 25-mg doses administered 3 weeks apart produced a statistically significant reduction in depressive symptom severity at week 6 compared with a 1-mg dose control, reinforcing findings from the companion COMP005 trial and advancing the program toward regulatory submission.

 Classic psychedelic; 5-HT2A receptor agonist

COMP005 (Phase 3, placebo-controlled); COMP006 (Phase 3, dose-controlled)

: –3.8 MADRS points vs 1 mg at week 6 (P < .001)

: 39% in 25-mg arm (COMP006)
Common Adverse Events: Headache, nausea, anxiety, visual hallucination

FDA Breakthrough Therapy designation; NDA discussions planned

“These results redefine rapidity and durability for TRD patients with onset as early as the next day and, for those who respond, effects from just one or two doses lasted at least through 26 weeks, alongside a well-tolerated safety profile,” said Guy Goodwin, MD, chief medical officer at Compass Pathways, in a statement.

COMP360 is a synthetic formulation of psilocybin, a classic serotonergic psychedelic that acts primarily as a 5-HT2A receptor agonist. Psychedelic compounds are hypothesized to induce rapid antidepressant effects through modulation of cortical network connectivity and promotion of neuroplasticity, in conjunction with structured psychological support.

In COMP006, the primary endpoint was the change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at week 6. The least squares mean difference between the 25-mg and 1-mg groups was –3.8 points (95% CI, –5.8 to –1.8; 

 In total, 39% of participants in the 25-mg arm achieved a ≥ 25% reduction in MADRS score at week 6.

The company also reported statistically significant separation from the comparator beginning the day after administration, with effects maintained through week 6. Longer-term data from Part B of COMP006, extending through week 26, are expected later in Q3 of 2026.

The parallel COMP005 trial, a randomized, double-blind, placebo-controlled study conducted in 258 participants in the United States, previously demonstrated a –3.6-point mean treatment difference on the MADRS at week 6 for a single 25-mg dose versus placebo (95% CI, –5.7 to –1.5; 

 <.001). Among participants achieving a ≥ 25% MADRS reduction at week 6, the durability of effect was reported through week 26 after 1 or 2 doses.

 Full phase 3 datasets have not yet been published in a peer-reviewed journal.

Estimates suggest that approximately 30% of patients with major depressive disorder (MDD) meet criteria for TRD, representing millions of adults in the United States.

 Patients with TRD experience higher functional impairment, increased health care utilization, and elevated suicide risk compared with those with treatment-responsive depression.

Current FDA-approved pharmacologic options specifically indicated for treatment-resistant depression (TRD) remain limited. These include adjunctive aripiprazole, brexpiprazole, and quetiapine, as well as esketamine nasal spray. Nonpharmacologic interventions include electroconvulsive therapy and repetitive transcranial magnetic stimulation.

COMP360 appears to be the first psychedelic therapy to consistently demonstrate a highly statistically significant improvement in MADRS scores across controlled trials.

Across COMP005 and COMP006, treatment-emergent adverse events were reported as generally mild to moderate and most commonly occurred on dosing days. Frequently reported events included headache, nausea, anxiety, and visual hallucination. Serious adverse events were reported in 5% of participants in COMP005 and 2% in COMP006; the suicidal ideation rate was < 1% across studies, with 1 suicidal behavior event occurring in the 1 mg arm of COMP006. An independent Data Safety Monitoring Board did not identify new or unexpected safety signals based on available data.

COMP360 has received Breakthrough Therapy designation from the US Food and Drug Administration (FDA) for TRD.

Compass Pathways has requested a meeting with the FDA and anticipates submitting a New Drug Application in Q4.

Detailed subgroup analyses, remission rates, functional outcomes, and comprehensive long-term safety data are pending. If confirmed through regulatory review and peer-reviewed publication, the COMP360 program would represent a novel therapeutic modality in TRD, characterized by limited dosing sessions and rapid onset of antidepressant effect.

“Across three robust, well-designed and well-executed clinical trials involving more than 1,000 participants, we have now demonstrated consistent, highly statistically significant results at the primary endpoint and a clinically meaningful effect,” said Compass Pathways Chief Executive Officer Kabir Nath, MBA, in a statement. “This is a remarkable achievement for the field of psychiatry—especially in the TRD population, where proving benefit has historically been extraordinarily challenging.”

Compass Pathways Successfully Achieves Primary Endpoint in Second Phase 3 Trial Evaluating COMP360 Psilocybin for Treatment-Resistant Depression. Compass Pathways. Published on February 17, 2026. Accessed on February 19, 2026. 

https://ir.compasspathways.com/News--Events-/news/news-details/2026/Compass-Pathways-Successfully-Achieves-Primary-Endpoint-in-Second-Phase-3-Trial-Evaluating-COMP360-Psilocybin-for-Treatment-Resistant-Depression/default.aspx

McIntyre RS, Alsuwaidan M, Baune BT, et al. Treatment-resistant depression: definition, prevalence, detection, management, and investigational interventions. 

Treatment-Resistant Depression. Cleveland Clinic. Published on May 16, 2023. Accessed on February 19, 2026. 

https://my.clevelandclinic.org/health/diseases/24991-treatment-resistant-depression

US Food and Drug Administration. Breakthrough Therapy designation. 

https://www.fda.gov/drugs/fast-track-breakthrough-therapy-accelerated-approval-priority-review/breakthrough-therapy

Compass Pathways’ synthetic psilocybin, COMP360, achieved the primary endpoint in a second phase 3 TRD trial (COMP006), showing a –3.8-point least squares mean MADRS difference at week 6 versus 1 mg control, with separation beginning the day after dosing. Two 25-mg sessions 3 weeks apart yielded clinically meaningful response in 39% (≥25% MADRS reduction). Findings align with prior COMP005 data and support an FDA submission planned for Q4 2026. Safety was generally mild-to-moderate, with low suicidal ideation rates.

Phase 3 COMP006 shows significant MADRS reduction at week 6, signaling potential benefit in treatment-resistant depression.

Psychiatry

Psychiatry condition center page is a comprehensive resource for clinical news and insights on mental illnesses. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for depression, schizophrenia, bipolar disorder, anxiety, and more.

Major Depressive Disorder

Major Depressive Disorder condition center page, resources on the topics of medical news and expert insight into depression can be found. Content includes articles, interviews, videos, podcasts, and breaking news on MDD research, treatment, and drug development.

COMP360 Psilocybin Meets Primary Endpoint in Second Phase 3 Trial for TRD

Edward Barnes, MD, MPH, is an associate professor of medicine in the division of gastroenterology and hepatology and co-director of the Multidisciplinary Inflammatory Bowel Diseases Center at the University of North Carolina at Chapel Hill.

Long-Term Crohn’s Disease Management: Inside the VIVID-2 Mirikizumab Data

Long-term durability remains one of the central questions in the management of moderate-to-severe Crohn’s disease. While many advanced therapies demonstrate strong induction and shorter-term maintenance data, clinicians often grapple with whether those benefits persist and whether safety signals emerge with longer exposure.

New 3-year results from the ongoing VIVID-2 extension study offer important insight into the sustained efficacy and safety of mirikizumab, a selective IL-23p19 monoclonal antibody that earned US Food and Drug Administration approval for Crohn’s in January 2025 based on positive results from the phase 3 VIVID-1 study in adults with moderately to severely active Crohn’s who had an inadequate response, loss of response, or intolerance to corticosteroids, immunomodulators, and/or biologics.

In an interview with HCPLive, Edward Barnes, MD, MPH, an associate professor of medicine in the division of gastroenterology and hepatology and co-director of the Multidisciplinary Inflammatory Bowel Diseases Center at the University of North Carolina at Chapel Hill, explained how the IL-23 class has generated significant enthusiasm in recent years because of its combination of robust efficacy and a favorable safety profile.

“What differentiates them is what I would consider an efficacy signal, meaning that it's effective in the treatment of Crohn's disease, but also combined with the safety signal. I think that is really attractive when you think about some of our more traditional therapies, which certainly have worked very well, but sometimes patients have concerns about potential long term adverse effects, or even in the short term as well, in terms of infectious complications or long term risks,” he explained. “I always tell my patients that all of our therapies are way more safe than having uncontrolled disease, but I think that's what really stands out when you think about the anti-interleukin 23 mechanism, which mirikizumab falls into.”

The VIVID-2 data extend outcomes to 3 years in patients who achieved endoscopic response at week 52 in the phase 3 VIVID-1 trial and continued mirikizumab maintenance therapy. Sustained remission rates were notable, including durable clinical remission and corticosteroid-free remission through week 152. The latter, Barnes stressed, is particularly critical.

Of note, durability was not limited to early responders. A subgroup of patients who were endoscopic nonresponders at week 52 underwent reinduction and demonstrated meaningful gains over time, with roughly 60% achieving clinical and corticosteroid-free remission by year three.

Patient-centered outcomes also remained a focus, with improvements in bowel urgency sustained through 3 years.

“I think bowel urgency is really important when we think about IBD in general,” Barnes said. “Urgency is a type of symptom that will keep patients from living the kind of life that they want to live… Finding a way to actually capture a clinically meaningful response in terms of urgency is critical, and so to be able to actually show that in an objective way, with the urgency numeric rating score in these data, is really key to show that over time as well, to that 3 year mark.”

Objective markers, including C-reactive protein and fecal calprotectin, also continued to decline, reinforcing the depth of response. Additionally, no new safety signals emerged over three years of exposure.

“These are the kind of data that we're able to see when we continue to follow patients long-term in these development programs, and I think this is really exciting to see this continued signal, and to see those patients that even got better when they weren't all the way where we want them in terms of clinical remission, corticosteroid free remission at week 52. We see that sort of catch up, and that's exciting to me too,” Barnes said.

Editors’ note: Barnes reports relevant disclosures with AbbVie, Bristol-Meyers Squibb, Lilly, and Target RWE.

Laharie D, Clemow D, Sands BE, et al. Mirikizumab Demonstrated Sustained and Durable Long-Term Efficacy and Favorable Safety in Week 52 Endoscopic Responders with Crohn’s disease: 3-year VIVID-2 Open-Label Extension Interim Results. Presented at 21st Congress of European Crohn’s and Colitis Congress (ECCO), February 18–21, 2026, Stockholm, Sweden.

Brooks A. FDA Approves Mirikizumab (Omvoh) for Crohn’s Disease. January 15, 2025. Accessed February 19, 2026. 

https://www.hcplive.com/view/fda-approves-mirikizumab-omvoh-for-crohn-disease

Barnes reviews 3-year VIVID-2 data showing durable remission, steroid-free control, and stable safety with mirikizumab in moderate-to-severe Crohn’s disease. 

Gastroenterology

Gastroenterology condition center page is a comprehensive resource for clinical news and insights on digestive and GI conditions. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for 

, IBS and IBD, Crohn's disease, and more.

Inflammatory Bowel Disease

On the HCPLive inflammatory bowel disease page, resources on the topics of medical news and expert insight into IBD can be found. Content includes articles, interviews, videos, podcasts, and breaking news on IBD and more.

3-Year Efficacy, Safety of Mirikizumab in Crohn’s Disease: Insights From VIVID-2, With Edward Barnes, MD, MPH

Abigail Brooks is an assistant managing editor for 

She joined MJH Life Sciences in August 2023 shortly after graduating from Monmouth University where she earned her BA in Communication with a concentration in Public Relations/Journalism and later an MA in Interactive Digital Media. She enjoys traveling, running, and reading books. She can be reached at abrooks@mjhlifesciences.com.

Positive results from a follow-up preclinical study of Thykamine show dose-dependent effects on key pathological hallmarks of MASH.

Hepatology

MASH / MASLD

The HCPLive MASH & MASLD page is a comprehensive resource for clinical news and insights on metabolic dysfunction-associated steatotic liver disease and steatohepatitis. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for fatty liver disease, steatohepatitis, and more.

Thykamine Shows Disease-Modifying Potential in MASH Using Liver-on-a-Chip Platform

Interim data from the investigator-initiated trial showed treatment with a single dose of YOLT-202 led to rapid, dose-dependent increases in AAT levels to normal range.

Alpha-1 antitrypsin deficiency

Single Dose YOLT-202 Gene-Editing Therapy Increases Functional AAT Levels in AATD

Muthiah Vaduganathan, MD, MPH, is a cardiologist specializing in cardiorenal metabolism at Brigham and Women's Hospital in Boston, MA. Vaduganathan is a member of Practical Cardiology's advisory board and co-host of Don't Miss a Beat, a podcast presented by Inside Cardiology.

Experts explain how uACR and eGFR testing reveals hidden CKD, links to heart risk, and guides early, patient-centered care.

Video Series

CKD Guidelines and Adherence Across Specialties

Abraham Kazemi, MD, is the director of Cosmetic and Laser Dermatology for Virginia’s Pinnacle Dermatology sites.

This segment of the latest Skin of Color Savvy episode highlights discoid lupus in skin of color, housing barriers, and Medicaid navigation.

Dermatology

The HCPLive dermatology page is a resource for medical news and expert insights on skin disease. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for dermatologic conditions, and more.

Skin of Color Savvy: The Art and Science of Treating Patients of Color

Hosted by Skin of Color Society and produced by HCPLive, 

 delves into the latest research, clinical insights, and culturally intelligent care practices in dermatology with leading experts. 

Whether it’s groundbreaking research, practice-changing insights, or highlights from the SOCS community, this twice-monthly program provides dermatologists and care providers with expert perspectives on treating patients with skin of color.

Addressing Discoid Lupus in Skin of Color: Clinical and Social Challenges

Learn how uACR and eGFR uncover hidden CKD, sharpen cardiovascular risk, and guide patient-friendly conversations for earlier, smarter care.

Addressing Chronic Kidney Disease (CKD) Prevalence and Patient Awareness in Cardiorenal Metabolic Care

Targeting CD28 and CD154 pathways, dual blockade with belatacept and dazodalibep offers a new mechanistic approach in kidney transplant care.

Mechanistic Rationale for Dual Costimulation Blockade, Belatacept, Dazodalibep in Kidney Transplantation

Ahmad Anouti, MD, is a pediatric resident at the University of Texas Southwestern in the Physician Scientist Training Program.

Anouti outlines why early bilirubin testing and emerging serum markers are key to improving prognosis in biliary atresia.

Advancing Prognostic Tools in Biliary Atresia Care, With Ahmad Anouti, MD

Nina Ajmone Marsan, MD, is a research fellow in the department of cardiology at Leiden University Medical Center.

Marsan and Santi discuss their recent study highlighting the need for lower LVESVi thresholds in aortic valve surgery in women to reduce mortality outcomes.

Female Patients With AR Exhibit Lower Mortality LVESVi Thresholds, With Nina Marsan, MD, and Pilar Santi, MD

A large specialty pharmacy cohort supports sustained reductions in attack rates across HAE subtypes, including normal C1 inhibitor disease.

Allergy

Allergy condition center page is a comprehensive resource for clinical news and insights on allergic and inflammatory diseases. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for food and seasonal allergies, as well as allergic asthma and related conditions.

Real-World HAE Control with Berotralstat at 18 Months, With Raffi Tachdjian, MD

Updated international guidance reinforces early self-administered on-demand therapy and integrates newer kallikrein-targeted agents into routine HAE management.


Latest News

BE RADIANT Trial: Bimekizumab Effective for Psoriasis After 3 Years of Use

Sodium Restrictions May Only Benefit Patients at Low Risk of HF, With Justin Ezekowitz, MD

Dual Costimulation Blockade May Eliminate Daily Oral Immunosuppression in Kidney Transplant

COMP360 Psilocybin Meets Primary Endpoint in Second Phase 3 Trial for TRD

3-Year Efficacy, Safety of Mirikizumab in Crohn’s Disease: Insights From VIVID-2, With Edward Barnes, MD, MPH