Secukinumab

Results from the Phase 3 VELA clinical trials at Week 52 in adults with moderate-to-severe hidradenitis suppurativa (HS) demonstrate sonelokimab’s (SLK) potential best-in-class and best-in-disease profile, with consistent responses that are higher than those observed in trials of competing agents at the end of their respective parental trials Namely, ~67% of patients treated with SLK achieved HiSCR75 at the one-year mark, with more than one quarter of patients achieving inflammatory remission (IHS4-100), and around one third reaching HiSCR100 Patients treated with SLK likewise showed substantial improvement in HiSQOL at Week 52, with a mean score difference between end of trial and baseline of -15.0 points, indicating an average change from “severe” to “mild” impairment of the HS-related quality of life Almost half of the patients experienced a marked reduction in pain (at least a 3-point improvement from baseline in the worst skin pain Numerical Rating Scale (NRS)) No new safety signals were detected in the VELA trials to date, supporting a consistent safety pro Week 52 Data from the VELA-TEEN trial in adolescent HS patients show strong therapeutic response and no new safety signals in adolescent patients, with nearly 70% of patients achieving HiSCR75 at Week 24 and almost half of patients reaching HiSCR100 Submission of the Biologics License Application (BLA) for SLK in HS, including data from adolescent patients, is expected at the end of September 2026, and will follow previous agency guidance on the label strategy An Investor Day webcast will be held on June 22, 2026, 8:00 – 9:30 a.m. EST (2:00 – 3:30 p.m. CET), to discuss these data and provide guidance on upcoming events ZUG, Switzerland, June 21, 2026 – MoonLake Immunotherapeutics (NASDAQ: MLTX) (MoonLake or the Company), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, today announced the Week 52 results of the Phase 3 VELA-1 and VELA-2 clinical trials of its registrational global program in patients with moderate-to-severe HS. The Company also announced that it will host an Investor Day webcast on June 22, 2026, 8:00 – 9:30 a.m. EST (2:00 – 3:30 p.m. CET), including an open Q&A session. Results from the Phase 3 VELA clinical trials at Week 52 Week 52 data for SLK showed consistent and further improvement in all clinical scores, compared to Week 16 data. Across both VELA-1 and VELA-2, 67.2% of patients treated with SLK achieved HiSCR75 and 33.1% of patients achieved HiSCR100 at Week 52 (n=396). The results were consistent across both trials (VELA-1: 68.3% HiSCR75, 31.2% HiSCR100; VELA-2: 66.0% HiSCR75, 35.1% HiSCR100). At Week 52, 26.0% of patients (n=396) achieved an IHS4-100 response (VELA-1: 24.4%, VELA-2: 27.7%), reflecting inflammatory remission, defined as a 100% reduction in abscesses (A100), nodules (N100) and draining tunnels (DT100). The long-term results of the VELA program are higher than in previous Phase 3 HS programs with competing agents (using the same pooled, as observed, end of parental trial data analysis). Relative to the competitor IL-17-A & F inhibitor monoclonal antibody, the SLK Nanobody ® , for example, showed responses with over ~10% more responding patients for HiSCR75, HiSCR100 or IHS4-100. The strong long-term clinical responses observed with SLK were accompanied by sustained improvements in Patient-Reported Outcomes, which are considered to matter most to patients living with HS and their treating physicians. Patients treated with SLK consistently showed the largest reductions in the HS-specific Quality of Life score (HiSQOL) at Week 52, with a -15.3 mean score difference between end of trial and baseline in VELA-1, and -14.8 in VELA-2 (as observed, n=395). The broader skin DLQI score confirmed the HiSQOL results and showed clinically meaningful response (≥4-point improvement from baseline) in 75.0% (VELA-1) and 69.4% (VELA-2) of patients (as observed, in patients with baseline DLQI ≥4, n=363). Responses for both these quality of life metrics were higher than previously demonstrated in competitor pivotal HS studies. In line with these data, 46.5% of patients experienced a marked reduction in pain, measured as at least a 3-point reduction from baseline in the worst skin pain NRS (VELA-1: 48.4%, VELA-2: 44.3%; as observed, in patients with baseline worst skin pain score of ≥3, n=241). These findings demonstrate leading and durable improvements across outcomes of key relevance for patients, including quality of life, pain and long-term disease control. Responses seen in patients crossing over from placebo (switch to SLK at Week 16) confirm and validate these findings. After 4 Weeks of SLK treatment, HiSCR75 rates increased by ~20 percentage points across both studies. At the end of the VELA program (i.e., after 36 weeks of SLK treatment), cross-over patients (“Placebo-to-SLK”) showed HiSCR75 rates similar to those observed after 36 weeks of treatment in the “SLK-to-SLK” arms (~60%, as observed). The high acceptance rate and good tolerability of SLK across the VELA program was confirmed by the rate of patients rolling over into the VELA-OLE (two-year open-label extension) following the parental trials (~90% across all arms) further validating the convenience of the 120mg Q4W (once every four weeks) dosing regimen. Interim Week 24 data from the Phase 3 VELA-TEEN trial Furthermore, data from the VELA-TEEN clinical trial showed rapid onset and high response rates in adolescent patients with HS. Interim analysis of Week 24 data show that ~68% of patients treated with SLK achieved HiSCR75, alongside ~86% achieving HiSCR50 and ~45% achieving HiSCR100 (as observed, n=22). HiSCR75 rates in VELA‑TEEN were higher than those observed in the adult VELA program at comparable timepoints, indicating a pronounced clinical response in adolescent patients with earlier stage disease. SLK was generally well tolerated in this vulnerable patient population, and no new safety signals were observed. These promising results highlight the relevance and opportunity of an early treatment of HS with the goal to slow down the progression to irreversible tissue damage. The safety pro SLK in the VELA clinical programs including VELA-TEEN remains consistent over time, with no new safety signals detected. Dr. Jorge Santos da Silva, Founder and Chief Executive Officer of MoonLake Immunotherapeutics, said: “The final Week 52 data from the VELA program confirm the strength of SLK across most, if not all, metrics that matter in HS: strong early efficacy, sustained and leading improvement over time, a consistent safety pro great convenience in dosing. All this, not just for adult patients but also for adolescent patients. Together with the alignment we have reached with the FDA on our HS label strategy, these data support the potential for a highly differentiated label pro reinforce our conviction that SLK has the potential to become a best-in-class and best-in-disease therapy for those living with HS.” Prof. Kristian Reich, Founder and Chief Scientific Officer of MoonLake Immunotherapeutics, added: “What is particularly compelling in the final Week 52 dataset is how consistently the strong clinical efficacy of SLK is reflected in Patient-Reported Outcomes. The sustained improvements we observed across HiSQOL, pain and broader quality of life measures are highly meaningful in HS, where the burden of disease extends far beyond lesion counts. In our view, these data highlight the potential of SLK to redefine long-term outcomes in HS by delivering durable disease control and meaningful improvements of the daily lives of patients combined with a favourable safety profile.” Next steps and anticipated BLA submission MoonLake plans to submit the BLA for HS to the FDA at the end of September 2026. The pre-BLA process is concluded and no more regulatory meetings with the FDA will take place. Clarity on the Prescription Drug User Fee Act (PDUFA) date is currently expected by the end of November 2026, concurrent with the FDA’s acceptance of the BLA. The Company plans to submit a request for Priority Review for this BLA based on SLK’s potential best-in-class pro well as its VELA-TEEN adolescent data; the FDA’s decision on the Priority Review request would be included in the application’s PDUFA date allocation/filing letter. Priority Review remains an upside scenario for MoonLake, subject to FDA resource and capacity considerations. If Priority Review is not granted, MoonLake expects a third or fourth quarter 2027 launch for SLK. Should Priority Review be granted, it is estimated that the time-to-market for SLK may be reduced by approximately one quarter. Investor Day, June 22, 2026 The Company will hold an Investor Day for investors and analysts on June 22, 2026 . The webcast will take place from 8:00 – 9:30 a.m. EST (2:00 – 3:30 p.m. CET), including an open Q&A session. A recording will be made available post-event. Webcast Access: In this session, MoonLake's CEO, Jorge Santos da Silva, CSO, Kristian Reich, and CFO, Matthias Bodenstedt, will present the final Week 52 data from the Phase 3 VELA program in HS and provide an update on the VELA‑TEEN clinical trial in adolescent HS, a recap of the proposed label, the Company’s view on its commercialization plan, as well as an outlook on H2 2026 events, including the readout of IZAR-1 Phase 3 trial in psoriatic arthritis (PsA). Important upcoming anticipated milestones for MoonLake: Mid 2026: Primary endpoint readout of the Phase 3 IZAR-1 trial in PsA Late Sep. 2026: Submission of a BLA for HS Late Nov. 2026: Expected PDUFA date allocation for HS BLA H2 2026: Primary endpoint readout of the Phase 3 IZAR-2 trial in PsA H2 2026: Interim readout of the Phase 2 P-OLARIS trial in PsA and axSpA -Ends- MoonLake Immunotherapeutics MoonLake Immunotherapeutics is a clinical-stage biopharmaceutical company unlocking the potential of sonelokimab, a novel investigational Nanobody ® for the treatment of inflammatory disease, to revolutionize outcomes for patients. Sonelokimab inhibits IL-17A and IL-17F by inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F dimers that drive inflammation. The Company’s focus is on inflammatory diseases with a major unmet need, including hidradenitis suppurativa, psoriatic arthritis, axial spondyloarthritis and palmoplantar pustulosis – conditions affecting millions of people worldwide with a large need for improved treatment options. MoonLake was founded in 2021 and is headquartered in Zug, Switzerland. Further information is available at . About Nanobodies ® Nanobodies ® represent a new generation of antibody-derived targeted therapies. They consist of one or more domains based on the small antigen-binding variable regions of heavy-chain-only antibodies (VHH). Nanobodies ® have a number of potential advantages over traditional antibodies, including their small size, enhanced tissue penetration, resistance to temperature changes, ease of manufacturing, and their ability to be designed into multivalent therapeutic molecules with bespoke target combinations. The terms Nanobody ® and Nanobodies ® are trademarks of Ablynx, a Sanofi company. About Sonelokimab Sonelokimab (M1095) is an investigational ~40 kDa humanized Nanobody ® consisting of three VHHs covalently linked by flexible glycine-serine spacers. With two domains, sonelokimab selectively binds with high affinity to IL-17A and IL-17F, thereby inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F dimers. A third central domain binds to human albumin, facilitating further enrichment of sonelokimab at sites of inflammatory edema. Sonelokimab is being assessed in two lead indications, hidradenitis suppurativa (HS) and psoriatic arthritis (PsA), and the Company is pursuing other indications in dermatology and rheumatology, including adolescent HS, palmoplantar pustulosis (PPP) and axial spondyloarthritis (axSpA). For adults with HS, sonelokimab is being assessed in two identical Phase 3 trials, the VELA-1 and VELA-2 trials, using the higher clinical response level of HS Clinical Response (HiSCR) 75 as the primary endpoint, which defines a response as an at least 75% reduction in abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count. In September 2025, the primary endpoint data from the VELA-1 and VELA-2 clinical trials were announced. In the combined VELA program, patients treated with SLK experienced a clinically meaningful and statistically significant improvement across all primary and key secondary endpoints using both pre-specified strategies (p<0.001). In VELA-1, SLK achieved statistical significance for all primary and key secondary endpoints using both pre-specified strategies (HiSCR75, delta to placebo of 17%, p<0.001). In VELA-2, intercurrent events in the higher-than-expected placebo arm precluded the study from achieving statistical significance in the Week 16 primary endpoint using the composite strategy (HiSCR75, delta to placebo of 9%, p=0.053). In June 2026, Week 52 Results of SLK from the VELA-1 and VELA-2 clinical trials were announced. Week 52 data for SLK showed consistent and further improvement in all clinical scores, compared to Week 16 data. Across both VELA-1 and VELA-2, 67.2% of patients treated with SLK achieved HiSCR75 and 33.1% of patients achieved HiSCR100 at Week 52 (as observed, n=396). The safety pro sonelokimab in the VELA trials was consistent with previous trials with no new safety signals detected. Sonelokimab is currently undergoing evaluation in the VELA-TEEN Phase 3 trial, which is the first clinical study specifically focused on adolescent patients with moderate-to-severe HS. In June 2026, interim Week 24 data from the Phase 3 VELA-TEEN trial were announced. Interim analysis of Week 24 data show that ~68% of patients treated with SLK achieved HiSCR75, alongside ~86% achieving HiSCR50 and ~45% achieving HiSCR100 (as observed, n=22). HiSCR75 rates in VELA‑TEEN were higher than those observed in the adult VELA program at comparable timepoints, indicating a pronounced clinical response in adolescent patients with earlier stage disease. SLK was generally well tolerated in this vulnerable patient population, and no new safety signals were observed. For PsA, sonelokimab is being assessed in the Phase 3 trials, IZAR-1 and IZAR-2, following the announcement in March 2024 of the full dataset from the global Phase 2 ARGO trial (M1095-PSA-201) evaluating the efficacy and safety of the Nanobody ® sonelokimab over 24 weeks in patients with active PsA. Significant improvements were observed across all key outcomes, including approximately 60% of patients treated with sonelokimab achieving an American College of Rheumatology (ACR) 50 response and Minimal Disease Activity (MDA) at Week 24. This followed the positive top-line results in November 2023, where the trial met its primary endpoint with a statistically significant greater proportion of patients treated with either sonelokimab 60mg or 120mg (with induction) achieving an ACR50 response compared to those on placebo at Week 12. All key secondary endpoints in the trial were met for the 60mg and 120mg doses with induction. The safety pro sonelokimab in the ARGO trial was consistent with previous trials with no new safety signals detected. Sonelokimab is also being assessed in PPP, a debilitating inflammatory skin condition affecting a significant number of patients, including in the completed Phase 2 LEDA program. In the Phase 2 LEDA clinical trial in PPP, SLK demonstrated clinically meaningful and statistically significant benefit. Patients treated with SLK achieved a mean percent change from baseline in the Palmoplantar Pustular Psoriasis Area and Severity Index (PPPASI) of 64% at Week 16, and 39% of patients achieved a ≥75% reduction in the PPPASI (PPPASI75), suggesting that SLK could provide clinically meaningful improvements in this disease for which there are currently no approved therapies. The safety pro SLK in the LEDA trial was consistent with previous trials with no new safety signals detected. Additionally, sonelokimab is being assessed in the ongoing Phase 2 S-OLARIS and P-OLARIS trials for active axSpA and PsA, respectively. Both trials feature an innovative design complementing traditional clinical outcomes with cellular imaging techniques. Sonelokimab has also been assessed in a randomized, placebo-controlled third-party Phase 2b trial (NCT03384745) in 313 patients with moderate-to-severe plaque-type psoriasis. High threshold clinical responses (Investigator’s Global Assessment Score 0 or 1, and Psoriasis Area and Severity Index 90/100) were observed in patients with moderate-to-severe plaque-type psoriasis. Sonelokimab generally presented a safety pro to the active control, secukinumab (Papp KA, et al. Lancet. 2021; 397:1564-1575). In an earlier third-party Phase 1 trial in patients with moderate-to-severe plaque-type psoriasis, sonelokimab decreased (to normal skin levels) the cutaneous gene expression of pro-inflammatory cytokines and chemokines (Svecova D. J Am Acad Dermatol. 2019; 81:196–203). About the VELA program The Phase 3 VELA program recruited a total of 838 patients across VELA-1 and VELA-2. Both global, randomized, double-blind, and placebo-controlled trials are identical in design evaluating the efficacy and safety of the Nanobody ® sonelokimab, administered subcutaneously, in adult patients with active moderate-to-severe hidradenitis suppurativa. Similar to the design of the landmark Phase 2 MIRA trial, the primary endpoint is the percentage of participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR) 75, defined as a ≥75% reduction in total abscess and inflammatory nodule (AN) count with no increase in abscess or draining tunnel count relative to baseline. The trials also evaluate a number of secondary endpoints, including the proportion of patients achieving HiSCR50, the change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4), the proportion of patients achieving a Dermatology Life Quality Index (DLQI) total reduction of ≥4, the proportion of patients achieving at least 50% reduction from baseline in Numerical Rating Scale (NRS50) in the Patient’s Global Assessment of Skin Pain (PGA Skin Pain) and complete resolution of Draining Tunnels (DT100). The VELA protocols and statistical analysis plans were prepared in accordance with regulatory agency advice and include two analysis strategies. The composite strategy for the VELA trials (also referred to as the primary estimand) is the primary statistical analysis. The protocol specifies the treatment policy strategy as the alternative method of handling intercurrent events to test the robustness of the VELA data. The trials compare a single 120mg dose of sonelokimab to placebo with HiSCR75 reading out at Week 16. Results of the Week 16 data were announced in September 2025. Results of the Week 52 data were announced in June 2026. Further details are available under NCT06411899 and NCT06411379 at . About the MIRA trial The MIRA trial is a global, randomized, double-blind, placebo-controlled Phase 2 trial to evaluate the efficacy and safety of the Nanobody ® sonelokimab, administered subcutaneously, in the treatment of adult patients with active moderate-to-severe hidradenitis suppurativa. The trial recruited 234 patients, with the aim to evaluate two different doses of sonelokimab (120mg and 240mg) with placebo control and adalimumab as an active reference arm. The primary endpoint of the trial is the percentage of participants achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75), defined as a ≥75% reduction in total abscess and inflammatory nodule (AN) count with no increase in abscess or draining tunnel count relative to baseline. The trial also evaluated a number of secondary endpoints, including the proportion of patients achieving HiSCR50, the change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4), the proportion of patients achieving a Dermatology Life Quality Index (DLQI) total score of ≤5, and the proportion of patients achieving at least 30% reduction from baseline in Numerical Rating Scale (NRS30) in the Patient’s Global Assessment of Skin Pain (PGA Skin Pain). Further details are available under NCT05322473 at . About the VELA-TEEN trial The Phase 3 VELA-TEEN trial is an open-label, single-arm trial designed to evaluate sonelokimab 120mg administered subcutaneously once every two weeks (Q2W) until week six and once every four weeks (Q4W) from week eight onwards. The trial enrolled 35 adolescents, aged 12-17, with moderate-to-severe hidradenitis suppurativa, from U.S. sites experienced in clinical trials and pediatric dermatology. The primary trial phase will be 24 weeks with a primary endpoint evaluating the pharmacokinetics, safety, and tolerability of sonelokimab. VELA-TEEN will also evaluate several secondary endpoints, including the proportion of patients achieving the higher clinical response measure of the Hidradenitis Suppurativa Clinical Response (HiSCR) 75, in addition to HiSCR50. Other outcomes are the change from baseline in the International Hidradenitis Suppurativa Severity Score System (IHS4), which includes the quantitative measure of draining tunnels, and the proportion of patients achieving a meaningful reduction of the Children’s Dermatology Life Quality Index (CDLQI) and the Patient’s Global Assessment of Skin Pain (PGA Skin Pain). Results of the interim Week 24 data were announced in June 2026. Further details are available under NCT06768671 at . About Hidradenitis Suppurativa Hidradenitis suppurativa (HS) is a severely debilitating chronic skin condition resulting in irreversible tissue destruction. HS manifests as painful inflammatory skin lesions, typically around the armpits, groin, and buttocks. Over time, uncontrolled and inadequately treated inflammation can result in irreversible tissue destruction and scarring. The disease affects an estimated 2% of the population, with three times more females affected than males. Real-world data in the United States indicate that at least 2 million unique patients have been diagnosed with and treated for HS between 2016 and 2023 alone, highlighting a significant unmet need and impact on healthcare systems, and a market opportunity projected to reach $15bn by 2035. Onset typically occurs in early adulthood and HS has a profound negative impact on quality of life, with a higher morbidity than other dermatologic conditions. There is increasing scientific evidence to support IL-17A- and IL-17F-mediated inflammation as a key driver of the pathogenesis of HS, with other identified risk factors including genetics, cigarette smoking, and obesity. About the IZAR Program IZAR-1 and IZAR-2 are global, randomized, double-blind, placebo-controlled Phase 3 trials designed to evaluate the efficacy and safety of sonelokimab compared with placebo in a total of approximately 1,500 adults with active psoriatic arthritis (PsA), with a primary endpoint of superiority to placebo in American College of Rheumatology (ACR) 50 response at Week 16. IZAR-1 is expected to enroll biologic-naïve patients and include an evaluation of radiographic progression, while IZAR-2 is expected to enroll patients with an inadequate response to tumor necrosis factor-α inhibitors (TNF-IR) – reflecting patients commonly seen in clinical practice – and is the first PsA trial to include a risankizumab active reference arm. Both trials will also assess a range of secondary endpoints reflecting the multiple disease manifestations characteristic of PsA. These include skin and nail outcomes, multidomain outcomes, and Patient-Reported Outcome measures such as pain and quality of life assessments. Further details are available under NCT06641076 and NCT06641089 at . About the P-OLARIS trial The P-OLARIS trial is a Phase 2 trial designed to evaluate the efficacy and safety of sonelokimab 60mg administered subcutaneously in adult patients with active psoriatic arthritis (PsA) or axial spondyloarthritis (axSpA) with a focus on characterizing how sonelokimab affects markers of inflammation and tissue damage within joints. The trial aims to recruit approximately 20 patients with PsA and 10 patients with axSpA. The primary endpoint is the change in disease activity at Week 12, as measured by [68Ga]-fibroblast activation protein inhibitor (FAPI)-tracer uptake (SUVmax) on FAPI-positron emission tomography (PET)/low-dose computed tomography (CT) scans, a novel imaging modality able to detect inflammation and early tissue damage within joints. Throughout the trial, several other endpoints will be assessed including established clinical disease activity outcomes, as well as patient reported outcomes that assess the impact of disease signs and symptoms. The trial also features an innovative exploratory peripheral blood and tissue biomarker program. The trial design has been informed by previous successful studies of sonelokimab, including the landmark Phase 2 ARGO trial in PsA as well as the Phase 2 S-OLARIS trial in axSpA which demonstrated the potential of sonelokimab to target deep tissue inflammation effectively. Further details are available under EUCT number 2024-514504-13-00 at . About Psoriatic Arthritis Psoriatic arthritis (PsA) is a chronic, progressive and complex inflammatory disease that manifests across multiple domains, leading to substantial functional impairment and decreased quality of life. The clinical features of PsA are diverse, comprising both musculoskeletal (peripheral arthritis, spondylitis, dactylitis, and enthesitis) and non-musculoskeletal (skin and nail disease) domains. PsA occurs in up to 30% of patients with psoriasis, most commonly those aged between 30 and 60 years. Although the exact mechanism of disease is not fully understood, evidence suggests that activation of the IL-17 pathway plays an important role in the disease pathophysiology. About the S-OLARIS trial The S-OLARIS trial is a Phase 2 trial designed to evaluate the efficacy and safety of sonelokimab 60mg administered subcutaneously in adult patients with active axial spondyloarthritis (axSpA). The trial recruited 26 patients. The primary endpoint is the change from baseline (CfB) in 18F-NaF SUVmax signals at Week 12 in the sacroiliac joints and spine as detected by PET. Throughout the trial, several other endpoints will be assessed including established clinical disease activity outcomes (e.g., ASAS), scores related to physical function, spinal mobility, and enthesitis as well as patient reported outcomes. The trial also features an innovative exploratory peripheral blood and tissue biomarker program. The trial design has been informed by previous successful studies of sonelokimab, including the landmark Phase 2 ARGO trial in psoriatic arthritis, which identified the optimal dosing and demonstrated the potential of sonelokimab to target deep tissue inflammation effectively. Further details are available under EUCT number 2024-513498-36-00 at . About Axial Spondyloarthritis Axial Spondyloarthritis (axSpA) typically impacts young people, with diagnosis based on chronic inflammatory back pain lasting more than three months with onset under 45 years of age. Advanced disease can lead to progressive and pathologic bone formation and joint fusion, severely limiting spinal mobility. Global reported prevalence of axSpA ranges from 0.5% to 1.5%. AxSpA can be categorized by disease progression into two subtypes: non-radiographic axSpA and ankylosing spondylitis (AS), also known as radiographic axSpA, which is diagnosed based on radiographic evidence of structural changes to the sacroiliac joints. Patients with axSpA experience fatigue, persistent morning stiffness, and pain that worsens at night and can disrupt sleep. Many patients also face the burden of comorbidities such as psoriatic arthritis and psoriasis. Studies have found elevated IL-17 levels in the blood and synovial fluid of patients with axSpA, and IL-17A and IL-17F are both thought to be key contributors to pathogenesis across the spondyloarthropathies. About the LEDA Trial The LEDA trial is a Phase 2 trial designed to evaluate the efficacy and safety of sonelokimab 120mg administered subcutaneously in adult patients with palmoplantar pustulosis (PPP). The trial recruited 32 patients. The primary endpoint of the trial is percent change from baseline in Palmoplantar Psoriasis Area and Severity Index (ppPASI) with important secondary endpoints including ppPASI75 (at least 75% improvement in the ppPASI). The LEDA trial features an innovative translational research program using peripheral blood and tissue biomarkers as trial controls. The trial design has been informed by previous successful studies of sonelokimab, including the landmark Phase 2 MIRA trial in hidradenitis suppurativa, which identified the optimal dosing and demonstrated the potential of sonelokimab to target deep tissue inflammation effectively. Further details are available under EUCT number 2024-513305-32-00 at . About Palmoplantar Pustulosis Palmoplantar Pustulosis (PPP) is characterized by the development of blister-like pustules within erythematous, scaly plaques on the palms and the soles of the feet. PPP typically develops in adulthood and more frequently impacts females. Patients frequently experience significant pain, burning, and itching sensations on the palms and soles of the feet which can be debilitating and impair their ability to work, sleep, or perform other activities of daily living. Currently, the treatment of PPP is challenging with a significant unmet need for novel therapies to reduce the symptom burden for patients. Evidence suggests that activation of the IL-17 pathway has an important role in disease pathophysiology. Cautionary Statement Regarding Forward Looking Statements This press release contains certain “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements regarding MoonLake’s expectations, hopes, beliefs, intentions or strategies regarding the future including, without limitation, statements regarding: the efficacy and safety of sonelokimab for the treatment of moderate-to-severe HS; the anticipated interactions with regulatory authorities, including the FDA, and the anticipated BLA-submission, PDUFA date and request for Priority Review; the proposed label and labeling discussions with the FDA for sonelokimab in HS, including potential inclusion of clinical data from the MIRA trial; potential market opportunities for sonelokimab; upcoming anticipated clinical milestones, including the primary endpoint readouts of the Phase 3 IZAR-1 trial in PsA and Phase 3 IZAR-2 trial in PsA, interim endpoint readout of the Phase 2 P-OLARIS trial in PsA and axSPA and submission of a BLA for HS; the FDA’s decision on Priority Review designation; and timing of first commercial launch in the United States. In addition, any statements that refer to projections, forecasts, or other characterizations of future events or circumstances, including any underlying assumptions, are forward looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that statement is not forward looking. Forward-looking statements are based on current expectations and assumptions that, while considered reasonable by MoonLake and its management, as the case may be, are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with MoonLake’s business in general and limited operating history; difficulty enrolling patients in clinical trials; state and federal healthcare reform measures that could result in reduced demand for MoonLake’s product candidates; reliance on third parties to conduct and support its preclinical studies and clinical trials; and the other risks described in or incorporated by reference into MoonLake’s Annual Report on Form 10-K for the year ended December 31, 2025, Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, and subsequent filings with the Securities and Exchange Commission. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. MoonLake does not undertake or accept any duty to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or in the events, conditions or circumstances on which any such statement is based. Contacts: MoonLake Immunotherapeutics Media & Investors Relations ir@moonlaketx.com ICR Healthcare Mary-Jane Elliott, Sarah Elton-Farr, Ashley Tapp Tel: +44 (0) 20 3709 5700 MoonLake@ICRHealthcare.com

巨细胞动脉炎（GCA）是老年人群最常见的系统性血管炎，主要累及颅外大动脉，可导致不可逆视力丧失。近年来，随着血管超声、PET-CT等影像学技术的普及，以及IL-6抑制剂（托珠单抗）等生物制剂的临床应用，GCA的诊疗策略正经历从"活检主导"向"影像+临床主导"、从"长期激素单药"向"生物制剂联合治疗"、从"经验性治疗"向"机制导向精准治疗"的范式转变。本文系统综述GCA的发病机制、诊断标准、治疗策略及长期管理的最新进展，并结合国际指南与关键临床试验证据，为临床实践提供参考。 一、引言 巨细胞动脉炎（Giant Cell Arteritis, GCA），又称颞动脉炎，是发生于50岁以上人群的慢性肉芽肿性大血管炎，年发病率约为15—25/10万（≥50岁人群），女性发病率约为男性的2—3倍[1]。GCA主要累及颞动脉及主动脉弓分支，也可累及眼动脉、椎动脉等，导致不可逆视力丧失甚至脑卒中。传统诊疗以颞动脉活检（Temporal Artery Biopsy, TAB）为"金标准"、以糖皮质激素为唯一一线治疗。然而，近年来影像学技术的飞跃与免疫靶向治疗的发展，正深刻重塑GCA的诊疗格局。2023年ACR/EULAR联合发布的GCA分类标准[2]、GiACTA试验的长期随访数据[3]、以及JAK抑制剂、IL-17A抑制剂等新靶点药物的临床试验结果，标志着GCA已进入"精准免疫治疗时代"。二、发病机制研究进展 GCA的发病机制涉及先天免疫与适应性免疫的复杂交互，血管壁的三层结构（内膜、中膜、外膜）均参与炎症反应。近年来，随着单细胞测序、空间转录组学等技术的发展，对GCA免疫病理的认识已深入至分子层面。2.1 经典免疫学机制 （1）抗原呈递与T细胞活化：树突状细胞（DC）在血管壁外膜摄取抗原后，迁移至血管旁淋巴结，激活CD4+ T细胞。活化的T细胞返回血管壁，释放IFN-γ、IL-17等细胞因子，驱动巨噬细胞分化为M1型（释放IL-6、TNF-α）和多核巨细胞，形成特征性的肉芽肿性炎症[4]。（2）Th1/Th17通路：Th1细胞通过IFN-γ激活巨噬细胞，介导组织破坏；Th17细胞通过IL-17招募中性粒细胞，放大炎症反应。两种通路的协同作用是GCA血管壁损伤的核心机制[5]。（3）细胞因子网络：IL-6是GCA中最关键的促炎细胞因子，其血清水平与疾病活动度高度相关，也是托珠单抗的治疗靶点。此外，IL-17A、GM-CSF、IL-12/IL-23等也参与炎症级联放大[6]。2.2 新兴机制（2023—2025年进展） （1）免疫衰老（Immunosenescence）：老年人群的胸腺退化、初始T细胞储备减少、记忆T细胞克隆扩增，导致免疫调节失衡。衰老的T细胞更易被血管壁内的自身抗原（如弹性蛋白、层粘连蛋白）激活，从而解释GCA的年龄依赖性发病倾向[7]。（2）克隆性造血（Clonal Hematopoiesis of Indeterminate Potential, CHIP）：2023年多项研究证实，GCA患者中CHIP突变（如DNMT3A、TET2、ASXL1）的携带率显著高于健康对照组。CHIP突变导致髓系细胞功能异常，释放IL-1β、IL-6等促炎因子，形成"炎症-突变"正反馈循环[8,9]。这一发现不仅解释了老年人群的发病倾向，也为靶向JAK-STAT通路提供了理论依据。（3）免疫检查点失调：PD-1/PD-L1通路在GCA血管壁中的表达下调，导致T细胞活化失控。2024年一项研究发现，GCA患者外周血中PD-1+耗竭T细胞比例升高，提示免疫检查点可能成为未来治疗靶点[10]。三、诊断进展3.1 临床诊断策略（仍为核心） GCA的典型临床表现包括：①新发头痛（约70%患者），多为颞部或枕部搏动性疼痛；②颞动脉压痛、增粗或搏动减弱（约50%）；③咀嚼困难（jaw claudication，约40%），因面动脉或舌动脉受累导致咀嚼肌缺血；④视力症状（约15—25%），包括一过性黑矇、复视、永久性视力丧失；⑤风湿性多肌痛（Polymyalgia Rheumatica, PMR）伴随症状（约40—50%），表现为颈、肩、骨盆带肌痛与晨僵[1,11]。⚠️ 核心原则：临床高度怀疑GCA时，必须立即启动糖皮质激素治疗，不应等待活检或影像学结果。延误治疗每增加1天，视力丧失风险显著增加。3.2 实验室指标 红细胞沉降率（ESR）和C反应蛋白（CRP）是传统的炎症标志物，约80—90%的GCA患者ESR>50 mm/h，CRP显著升高。然而，约10—20%的GCA患者（尤其局限性GCA或早期病例）可出现ESR/CRP正常[11]。近年来，血清IL-6水平被认为比ESR/CRP更敏感，与疾病活动度相关性更强，但尚未在临床常规开展[6]。血小板增多（>400×10⁹/L）是另一个常见但非特异性的实验室异常。3.3 影像学革命（当前最大变化） 影像学技术的进步是近年来GCA诊断领域最显著的变革，2023年ACR/EULAR分类标准已将影像学纳入核心诊断要素[2]。3.3.1 血管超声（首选筛查工具） 血管超声（Vascular Ultrasound, VUS）已成为GCA的一线影像学检查，在欧洲部分国家已取代颞动脉活检作为常规诊断手段[12]。• "晕征"（Halo sign）：表现为颞动脉管壁低回声增厚（>0.5 mm），周围环绕无回声管腔，是GCA的特征性表现。其敏感性约为75—85%，特异性约为85—95%[13]。• 优势：无创、快速（床旁即可完成）、可重复、无辐射、成本低廉。• 局限：操作者依赖性较强；对颅外大血管（如主动脉）评估能力有限；肥胖患者图像质量可能下降。• 推荐方案：双侧颞动脉、面动脉、枕动脉、腋动脉超声检查，以提高检出率。3.3.2 PET-CT / CTA / MRA 对于大血管型GCA（Large-Vessel GCA, LV-GCA）或颅外血管受累者，PET-CT、CTA、MRA具有重要价值：• PET-CT：通过¹⁸F-FDG摄取评估血管壁炎症活动，敏感性约80—90%，可同时评估主动脉及其分支。2023年EULAR指南推荐PET-CT用于评估GCA的大血管受累及疾病活动度[14]。 • CTA/MRA：用于评估血管壁增厚、管腔狭窄/扩张、动脉瘤形成。CTA空间分辨率高，但需碘造影剂；MRA无辐射，但检查时间长、费用高。• 临床应用：①初诊时评估大血管受累范围；②随访时监测主动脉瘤形成；③复发时鉴别活动性炎症与纤维化狭窄。3.3.3 影像学诊断策略流程 【推荐诊断流程】（基于2023 ACR/EULAR标准及EULAR 2023指南[2,14]）：   疑似GCA患者（≥50岁，新发头痛+炎症指标升高）           ↓  第一步：立即启动糖皮质激素治疗（泼尼松40-60 mg/d）           ↓  第二步：床旁血管超声（双侧颞动脉+面动脉+枕动脉）           ↓  ┌──────────────┬──────────────┐  ↓              ↓              ↓超声阳性      超声阴性/不确定   大血管症状/体征（Halo sign）                    （主动脉杂音、                                  肢体脉搏减弱）  ↓              ↓              ↓临床确诊GCA   考虑PET-CT/MRA   行PET-CT/CTA/MRA              或颞动脉活检  ↓              ↓              ↓评估大血管    仍阴性但临床高度   评估大血管受累范围      怀疑→颞动脉活检   炎症范围  ↓              ↓              ↓制定治疗      制定治疗方案      制定治疗方案与随访方案    与随访方案        与随访方案 注：以上流程不适用于已接受激素治疗>1周的患者，此时影像学敏感性下降。3.4 颞动脉活检（TAB） TAB仍是GCA病理诊断的"金标准"，其特征性表现为：血管壁全层炎症、内膜增生、中膜弹性纤维断裂、多核巨细胞浸润（围绕弹性纤维或血管腔分布）。然而，TAB的地位正在下降：• 敏感性受限：由于GCA病变呈"跳跃性"（skip lesions）分布，单节段活检的敏感性仅约60—80%。双侧活检可提高敏感性至85—90%，但临床实践中常因患者拒绝或手术风险而未实施[15]。• 激素治疗后仍可阳性：但敏感性随治疗时间延长而下降，>2周者阳性率显著降低。• 有创性：局部麻醉下手术，并发症包括血肿、感染、面神经损伤（罕见），发生率约1—3%。【当前推荐】：TAB适用于以下情况：①临床与影像学表现不一致的疑难病例；②超声阴性但临床高度怀疑GCA；③需要病理确诊以排除其他血管炎（如结节性多动脉炎、ANCA相关性血管炎）；④研究或教学目的。对于超声阳性且临床表现典型的患者，可不行TAB[2,14]。四、治疗进展4.1 糖皮质激素：仍然不可替代的一线标准 糖皮质激素是目前唯一可快速预防GCA所致视力丧失的治疗手段，其抗炎作用可迅速抑制血管壁炎症。【具体方案】[1,11,16]：• 无视力症状：泼尼松（或等效剂量的甲泼尼龙）40—60 mg/d（或1 mg/kg/d），晨起顿服。• 视力受累或中枢神经系统症状：甲泼尼龙静脉冲击治疗，500—1000 mg/d，连续3天，随后转为口服泼尼松1 mg/kg/d。• 激素减量方案：  – 第1—2周：症状控制后，每1—2周减量10 mg；  – 降至20 mg/d后：每2—4周减量2.5—5 mg；  – 降至10 mg/d后：每4—8周减量1—2.5 mg；  – 目标：6—18个月内停药，但部分患者需低剂量维持（2.5—5 mg/d）更长时间。4.2 激素减量与联合治疗（重要进展）4.2.1 托珠单抗（Tocilizumab，IL-6受体拮抗剂） 托珠单抗是近年来GCA治疗领域最重要的突破，其通过阻断IL-6受体抑制炎症信号通路，显著降低复发率并减少激素累积剂量。【关键证据】：• GiACTA试验（2017年发表，2023年长期随访数据更新）：这是一项随机、双盲、安慰剂对照的III期临床试验，纳入251例新发或复发性GCA患者。结果显示：  – 托珠单抗+26周激素方案：持续缓解率56%（vs 安慰剂+26周激素14%）；  – 托珠单抗+52周激素方案：持续缓解率53%（vs 安慰剂+52周激素18%）；  – 激素累积剂量减少约50%[3,17]。• 2023年长期随访（中位随访2.5年）：托珠单抗组复发率约30%（vs 安慰剂组约50%），严重不良事件发生率相似，未增加感染风险[17]。【推荐用法】[16,18]：• 皮下注射：162 mg/次，每周1次（体重<100 kg）或每2周1次（体重≥100 kg，部分指南推荐）。• 静脉输注：8 mg/kg，每4周1次（最大剂量800 mg/次）。• 疗程：至少12个月，部分患者需长期维持（尤其复发高危者）。• 联合方案：与激素同步启动，激素按标准方案减量。【指南推荐】：2021年EULAR指南、2023年ACR指南均将托珠单抗列为GCA的一线激素节省策略（1A级证据）[16,18]。在中国，托珠单抗已纳入国家医保目录（2023年版），适用于对标准激素治疗反应不佳或复发的GCA患者。4.2.2 传统免疫抑制剂 • 甲氨蝶呤（Methotrexate, MTX）：多项随机对照试验（如2010年Cochrane综述）显示，MTX（7.5—15 mg/周）可减少激素用量和复发率，但效应量中等。2021年EULAR指南将其作为托珠单抗不可用时的替代选择（2B级证据）[16]。• 来氟米特（Leflunomide）：2022年一项回顾性研究显示，来氟米特（20 mg/d）在复发性GCA中有效，可作为MTX不耐受者的替代，但证据等级较低[19]。• 环磷酰胺（Cyclophosphamide）：仅用于重症或难治性GCA（如主动脉炎、中枢神经系统受累），因毒性较大，不作为常规选择。4.2.3 新兴靶向治疗（2024—2025年热点） 以下药物仍处于临床试验阶段，尚未进入一线指南，但代表了GCA精准治疗的方向：（1）JAK抑制剂：• 托法替布（Tofacitinib）：II期临床试验（NCT03974009）显示，5 mg bid可显著降低GCA复发率，且安全性良好。JAK抑制剂可同时抑制JAK1/3（IL-6信号）和JAK2（GM-CSF信号），具有多靶点优势[20]。• 巴瑞替尼（Baricitinib）：早期探索性研究显示对难治性GCA有效，但需更大样本验证。 （2）IL-17A抑制剂：• 司库奇尤单抗（Secukinumab）：基于Th17通路在GCA中的作用，II期试验正在进行中（NCT05080084）。• 依奇珠单抗（Ixekizumab）：类似机制，早期数据尚待公布。 （3）GM-CSF抑制剂：• Mavrilimumab：靶向GM-CSF受体α，2024年II期试验显示可减少激素用量，但样本量较小[21]。（4）T细胞共刺激调节药物：• 阿巴西普（Abatacept）：CTLA-4-Ig融合蛋白，阻断CD28-B7共刺激信号。2022年一项随机试验显示可减少复发，但差异未达统计学显著性，需进一步研究[22]。 ⚠️ 重要提示：上述新兴疗法均处于研究阶段，不推荐在临床常规使用，除非患者符合临床试验入组条件。五、复发与长期管理 GCA属于高复发性疾病，即使在接受规范治疗的情况下，复发风险仍较高。【复发率】：• 单用激素：约50%患者在激素减量过程中复发[1]。• 激素+托珠单抗：复发率降至约30%（GiACTA试验数据）[3]。• 激素+MTX：复发率约40—45%（Meta分析数据）。【复发定义】（基于2021年EULAR标准[16]）：• 临床复发：原有症状重新出现（如头痛、PMR症状）或新出现GCA相关症状（如视力变化、 jaw claudication）。• 影像学复发：血管超声或PET-CT显示血管壁炎症重新活动。• 生化复发：ESR/CRP再次升高（但需排除感染等其他原因）。【复发处理策略】：• 轻度复发（仅ESR/CRP升高，无临床症状）：可暂不增加激素，密切观察，必要时调整免疫抑制剂。• 中度复发（症状重现，无视力威胁）：增加激素至前一次有效剂量，或加用/换用托珠单抗。• 重度复发（视力威胁或中枢神经系统症状）：甲泼尼龙冲击治疗（500—1000 mg/d×3天），并考虑加用托珠单抗或环磷酰胺。【长期并发症监测】：• 心血管并发症：GCA患者主动脉瘤（尤其胸主动脉）风险增加约3—5倍，建议每年行胸部/腹部CTA或超声筛查[23]。• 脑血管并发症：椎动脉或颈动脉受累可导致脑卒中，需定期评估神经系统体征。• 激素相关并发症：骨质疏松（建议基线及每年DEXA扫描）、糖尿病、高血压、白内障、感染风险。建议所有患者补充钙剂（1000—1200 mg/d）+维生素D（800—1000 IU/d），必要时使用双膦酸盐或地舒单抗[16]。【随访方案】：• 每4—8周评估临床症状、ESR/CRP、血常规、肝肾功能。• 每6—12个月行血管超声或CTA评估大血管状态。• 每年行胸部/腹部影像学筛查主动脉瘤。• 托珠单抗治疗期间：每4—8周监测血脂（IL-6抑制可升高LDL-C）、肝功能、血常规。六、诊疗策略的新范式（2025年共识趋势） 综合国际指南更新与临床试验证据，GCA的诊疗策略可概括为"三个转变"：【转变一：从"活检主导" → "影像 + 临床主导"】血管超声（Halo sign）和PET-CT已成为一线诊断工具，TAB从"必做"变为"选做"。2023年ACR/EULAR分类标准中，影像学阳性可获得较高评分，体现了这一转变[2]。【转变二：从"长期激素单药" → "生物制剂联合治疗"】托珠单抗作为"标准激素节省策略"已获国际指南一致推荐，JAK抑制剂等新靶点药物正在改变治疗格局。未来，GCA的治疗可能类似于类风湿关节炎，进入"生物制剂/靶向药物时代"[16,18]。【转变三：从"经验性治疗" → "机制导向精准治疗"】基于免疫衰老、CHIP、Th1/Th17通路等机制研究，未来可能实现GCA的分子分型与分层治疗：• IL-6高表达型 → 托珠单抗；• IL-17/Th17主导型 → IL-17A抑制剂；• JAK-STAT通路激活型 → JAK抑制剂；• GM-CSF驱动型 → GM-CSF抑制剂。这一愿景虽尚未实现，但已展现出清晰的方向[7,20,21]。七、总结与展望 颞动脉炎的诊疗正进入"精准免疫治疗时代"，其核心特征包括：• 早期诊断：影像学主导（血管超声+PET-CT），实现快速、无创、可重复的评估；• 标准治疗：糖皮质激素仍不可替代，但联合托珠单抗已成为国际共识；• 关键进展：IL-6抑制剂显著改变GCA的自然病程，降低复发率和激素毒性；• 未来方向：JAK抑制剂、IL-17A抑制剂、GM-CSF抑制剂等新靶点药物，结合免疫衰老、CHIP等机制研究，推动GCA从"经验性治疗"向"机制导向精准治疗"转型。对于临床医生而言，掌握影像学诊断技能、及时启动激素治疗、合理应用托珠单抗，是改善GCA患者预后的关键。同时，积极参与临床试验、关注新靶点药物进展，将为GCA患者带来更多治疗选择。八、中国诊疗现状与差距 与国际先进水平相比，中国GCA诊疗仍存在以下差距：• 诊断延迟：由于GCA认知度不足，许多患者首诊于眼科或神经内科，延误至风湿免疫科的时间平均为2—4周。• 影像学普及率低：血管超声在GCA诊断中的应用尚未普及，多数医院仍依赖TAB。• 生物制剂可及性：托珠单抗虽已纳入医保，但部分基层医院尚未配备，患者需转诊至上级医院。• 长期随访不足：主动脉瘤筛查、骨密度监测等长期管理措施执行率较低。建议：①加强风湿免疫科与眼科、神经内科、影像科的多学科协作；②推广血管超声技术培训；③建立GCA专病数据库，开展真实世界研究；④积极参与国际临床试验，加速新靶点药物的可及性。 九、参考文献 [1] Dejaco C, Ramiro S, Duymus M, et al. 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