Alexa B. Kimball, MD, MPH, serves as a professor of dermatology at Harvard Medical School as well as president and CEO of Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center. 

Alexa Kimball, MD, MPH

Tulisokibart, an investigational monoclonal antibody targeting tumor necrosis factor-like ligand 1A (TL1A), outperformed placebo on lesion response at week 16 in the phase 2b MK-7240-012 trial (NCT06956235) in adults with moderate to severe hidradenitis suppurativa (HS). Merck reported the results as a late-breaking abstract at the 

2026 European Academy of Dermatology and Venereology (EADV) Congress

“Results from the MK-7240-012 trial are promising,” said Alexa B. Kimball, MD, MPH, professor of dermatology at Harvard Medical School, president and CEO of Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center, and lead investigator of the trial.¹

During the randomized, double-blind study, Kimball et al assigned 149 individuals to be treated with tulisokibart 480 mg every 2 weeks (n = 42), 480 mg every 4 weeks (n = 42), 240 mg every 4 weeks (n = 21), or placebo (n = 44), with a Bayesian primary analysis incorporating historical placebo data.¹ At week 16, HiSCR50 response attained 72% and 64% with the 2 higher doses vs 35% with placebo, meeting the team’s main end point. The low dose, evaluated by the investigators as an exploratory arm, saw HiSCR50 among 52%.

HiSCR75 rates followed a dose-dependent pattern at 41%, 40%, and 29% across the high, medium, and low doses, compared with 15% for placebo.¹ The high dose also produced the largest gain in Dermatology Life Quality Index (DLQI), with a mean change of -5.62 vs -2.46 with placebo.²

TL1A inhibition represents a mechanism distinct from the tumor necrosis factor and interleukin-17 pathways targeted by HS biologics approved to date, and tulisokibart is also in phase 3 development for ulcerative colitis and Crohn’s disease.¹ In the following interview, Kimball spoke with 

 at EADV 2026 in Vienna about the standout efficacy findings and the biologic rationale for targeting TL1A in HS:

: What were the key takeaways from the phase 2b MK-7240-012 trial of tulisokibart in HS, and which efficacy findings stood out most?

 First, HS has been on an incredible journey of exciting developments in terms of how we manage our patients, with really improving efficacy and safety over the past decade. It’s been amazing. This latest set of data for tulisokibart in this phase 2 program continues to show that we can reach high levels of efficacy. We were very excited because this is a new mechanism of action in the world of dermatology, which is TL1A inhibition. What we saw in this program was that, in this 3-arm dosing regimen vs placebo, HiSCR50 and HiSCR75 at week 16 showed very strong results, in the highest tier of efficacy results that we have seen to date.

: What is the biologic rationale for targeting TL1A in HS, and how might this mechanism differ from TNF and IL-17 inhibitors?

 Many people will be familiar with the use of TNF inhibitors throughout dermatology, and certainly for HS, that’s where we really started our efficacy and therapeutic journey for our patients. TL1A is actually a related cytokine to TNF. It’s in the TNF superfamily of cytokines, but it works through a different mechanism. More precisely, it’s a co-stimulatory molecule, and we were investigating a lot of co-stimulatory molecules even 20 years ago to try to break the cycle of inflammatory activation as cells talk to each other to get that cascade going.

You need a number of different things to happen. The way to think about it is like a docking mechanism. There are multiple pieces in the dock that come together to get that activity, and this is one of them. If you don’t have that docked, you have a wobbly interaction.

What’s interesting about TL1A, though, is that it interacts with something called DR3, or death receptor 3, which makes you wonder what death receptor 1 is. In any event, DR3 is found on a lot of different types of inflammatory cells, so in some ways, it has a very broad impact. What we’re trying to figure out is how this translates into the therapeutic benefits we see.

One other interesting element of the TL1A pathway is that it may have an antifibrotic effect. HS is a disease with a lot of scarring, so that would certainly be a substantial benefit to our patients if that part of the mechanism of action pans out in a way that is helpful in how scars develop and remodel over time.

Editor’s Note: This transcript has been edited for grammar and clarity using artificial intelligence tools. Kimball has disclosed her work a paid consultant for Merck.

Merck. Merck’s tulisokibart met primary and key secondary endpoints in phase 2b study in patients with moderate to severe hidradenitis suppurativa (HS). Published September 30, 2026. Accessed November 3, 2026. 

https://s2.q4cdn.com/584635680/files/doc_news/Mercks-Tulisokibart-Met-Primary-and-Key-Secondary-Endpoints-in-Phase-2b-Study-in-Patients-With-Moderate-to-Severe-Hidradenitis-Suppur-QPD75.pdf

Smith T. Tulisokibart shows phase 2b efficacy in moderate to severe HS. 

. Published September 30, 2026. Accessed November 3, 2026. 

https://www.hcplive.com/view/tulisokibart-phase-2b-efficacy-moderate-severe-hs

Articles

In this segment of her interview, Kimball discusses phase 2b tulisokibart data in hidradenitis suppurativa and the rationale for targeting TL1A.

Q&A: Tulisokibart Results and TL1A Inhibition in HS, With Alexa Kimball, MD, MPH

VELA: Phase 3 Data Suggest Sonelokimab Effective for HS, With Alexa Kimball, MD, MPH

2026 American Academy of Dermatology (AAD) Annual Meeting

 suggest sonelokimab may deliver sustained clinical and quality-of-life improvements for adults with moderate-to-severe hidradenitis suppurativa (HS).

These findings resulted from the phase 3 VELA-1 and VELA-2 trials. In an on-site interview, VELA trial investigator Alexa Kimball, MD, MPH, of Harvard Medical School, discussed the broader implications of these findings, including how higher response thresholds like Hidradenitis Suppurativa Clinical Response (HiSCR) 75 may help redefine treatment goals and expectations in HS management.

“What was great to see in the data…is that the efficacy seems to be quite have a very high slope at the beginning of treatment and then continues to improve over time through Week 40 with hidradenitis suppurativa,” Kimball expressed.

838 individuals were assessed in the global VELA program, with investigators utilizing the more stringent HiSCR 75 as their primary endpoint, reflecting at least a 75% reduction in patients’ abscess and inflammatory nodule count without worsening of abscesses or draining tunnels. Kimball et al found, by Week 40, approximately 62% of those on sonelokimab attained HiSCR75, with up to 32% achieving complete lesion clearance (HiSCR100).

These findings were described as consistent across both analyses, suggesting a high level of durable disease control with the drug’s use. Additional measures of HS severity and symptom burden also demonstrated meaningful improvement, Kimball and colleagues found. Up to 77% of those evaluated achieved at least a 55% reduction in International HS Severity Scoring System (IHS4-55), and approximately a quarter reached inflammatory remission. Such outcomes point to substantial reductions in inflammatory activity.

Notably, Kimball and coauthors’ clinical gains were accompanied by notable improvements in the patient-reported outcomes seen in the VELA program. Quality-of-life scores, as determined by the HS Quality of Life (HiSQOL) instrument, were found to have risen significantly through the 40-week mark, with many individuals on the drug transitioning from severe baseline impairment to mild or no impact.

Additionally, the investigators noted improvements across key functional and emotional domains, including mobility, pain, and mood. Kimball and colleagues also found up to 43% of subjects reported clinically meaningful reductions in their level of pain, and roughly two-thirds achieved meaningful improvements in Dermatology Life Quality Index (DLQI) scores.

The safety profile of this medication was shown to be consistent with earlier findings, with Kimball et al finding no new safety signals over 40 weeks of treatment.

Kimball’s institution received grants from Abbvie, Admirx, Anapyts Bio, Aristea, Bristol Myers Squibb, Chemocentryx, Eli Lilly, Incyte, Janssen, MoonLake, Novartis, Pfizer, Prometheus, UCB; Sonoma Bio. Kimball received consulting fees from Abbvie, Alumis, Bayer, Bristol Myers Squibb, Boehringer Ingelheim, Eli Lilly, Janssen, Moonlake Novartis, Pfizer, Priovant, Sonoma Bio, Sanofi, UCB; Target RWE, Ventyx; and serves on the board of directors of Almirall.

MoonLake announces Week 40 Results from its Phase 3 Clinical Trials of Sonelokimab in Hidradenitis Suppurativa at the 2026 AAD Annual Meeting. MoonLake. March 28, 2026. Accessed March 30, 2026. 

https://www.globenewswire.com/news-release/2026/03/28/3264203/0/en/MoonLake-announces-Week-40-Results-from-its-Phase-3-Clinical-Trials-of-Sonelokimab-in-Hidradenitis-Suppurativa-at-the-2026-AAD-Annual-Meeting.html

Kimball A. Sonelokimab in moderate-to-severe HS: long-term results through week 40 of two phase 3 trials. Presented at: 2026 American Academy of Dermatology Annual Meeting; March 27-31, 2026; Denver, CO.

Videos

This interview highlights phase 3 findings on sonelokimab for individuals with hidradenitis suppurativa (HS).

On March 13, the US Food and Drug Administration (FDA) 

, specifically those aged 12 years and older.

This approval, positioning secukinumab as the only interleukin (IL)-17A inhibitor currently indicated for this population, made this the first differentiated mechanism in nearly a decade. In light of the FDA’s addition of this biologic option to the limited agents available in the pediatric HS armamentarium, the 

 team interviewed Alexa Kimball, MD, MPH.

Kimball, the president and CEO of Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center and professor of dermatology at Harvard Medical School, was an investigator on the trial program leading up to this approval. The following Q&A transcribes her responses to 

This approval marks the first new mechanism in pediatric HS in nearly a decade, and only the second approved treatment option for this population overall. How significant is that from a clinical standpoint?

Studies suggest that initiating treatment early in the HS disease course is associated with higher responsiveness to treatment. This advantage is consistent with what I have experienced with the patients I treat. Intervening before scars and tunnels develop is a clear clinical goal for our patients

The label is supported by a combination of adult HS trial data, pharmacokinetic modeling, and pediatric data extrapolated from other indications. Can you walk us through why that evidentiary approach was appropriate here, and how confident you are in the weight-based dosing regimen?

I defer to the FDA on this question. It does appear that the methodology used here is consistent with how other similar approvals have been evaluated.

HS in adolescence carries a particularly heavy psychosocial burden. Did you see meaningful quality-of-life improvements in younger patients alongside the clinical endpoints, and how do you weigh those outcomes when evaluating a therapy for this age group?

We would need specific studies to determine the answer to your question above. There is a concept increasingly accepted across dermatology emphasizing that early treatment for chronic dermatologic diseases is important because success can alter important trajectories such as education, employment and relationships. That concept, Cumulative Life Course Impairment, would further support the important of early treatment.

Secukinumab already carries more than a decade of real-world safety data. How much does that established track record factor into your comfort level prescribing it to a pediatric population, and are there any monitoring considerations specific to adolescents that clinicians should keep in mind?

Working with medications with established safety profiles is always reassuring. There isn’t any monitoring I would do differently in adolescents than in adults.

Kimball’s institution received grants from Abbvie, Admirx, Anapyts Bio, Aristea, Bristol Myers Squibb, Chemocentryx, Eli Lilly, Incyte, Janssen, Moonlake, Novartis, Pfizer, Prometheus, UCB; Sonoma Bio. Kimball received consulting fees from Abbvie, Alumis, Bayer, Bristol Myers Squibb, Boehringer Ingelheim, Eli Lilly, Janssen, Moonlake Novartis, Pfizer, Priovant, Sonoma Bio, Sanofi, UCB; Target RWE, Ventyx; and serves on the board of directors of Almirall.

Smith T. FDA Approves Secukinumab for Pediatric Patients 12 Years and Older with HS. HCPLive. March 13, 2026. Accessed March 18, 2026. 

https://www.hcplive.com/view/fda-approves-secukinumab-for-pediatric-patients-12-years-older-hs

Novartis Cosentyx® receives FDA approval for pediatric patients aged 12+ with moderate to severe hidradenitis suppurativa. Novartis. March 13, 2026. Accessed March 18, 2026. 

https://www.novartis.com/us-en/news/media-releases/novartis-cosentyx-receives-fda-approval-pediatric-patients-aged-12-moderate-severe-hidradenitis-suppurativa

The FDA approved secukinumab for moderate to severe hidradenitis suppurativa in patients aged ≥12 years, establishing the only IL-17A inhibitor indicated for this age group and introducing the first differentiated mechanism in nearly a decade. Early intervention was emphasized as clinically meaningful, with greater treatment responsiveness when initiated before irreversible scarring and sinus tract formation. The evidentiary basis combined adult HS trials, pharmacokinetic modeling, and pediatric extrapolation. Longstanding real-world safety experience was cited as reassuring, without adolescent-specific monitoring differences.

This Q&A highlights Dr. Alexa B. Kimball's responses to questions on the FDA approval of secukinumab for pediatric patients with hidradenitis suppurativa (HS).