litifilimab (BIIB059) / Biogen, Royalty - LARVOL DELTA

Validation of Cutaneous Lupus Erythematosus Disease Area and Severity Index-Activity (CLASI-A) for Evaluation of Patients with Cutaneous Lupus Erythematosus in Clinical Trials (ACR Convergence 2026) - P2 | "Although the content validity of the CLASI-A is well-supported,1,2 its broader psychometric properties (including construct validity, reliability, and responsiveness) remain under-evaluated in large-scale clinical study populations.2,3 Here we assess the psychometric properties of the CLASI-A using data from participants with active CLE in Part B of LILAC (NCT02847598), a two-part, Phase 2, randomized, double-blind, placebo-controlled study of litifilimab.4 Construct validity was assessed using convergent and divergent validity and the known groups method... Psychometric analyses using data from the Phase 2 LILAC study confirm that the CLASI-A is a valid, reliable, and responsive measure of skin disease activity in patients with CLE."

Clinical • Cutaneous Lupus Erythematosus • Immunology • Inflammatory Arthritis • Lupus

Litifilimab Improves Clinician and Patient Reported Skin Changes in Cutaneous Lupus Erythematosus: 52-Week Results from the Phase 2 Study, AMETHYST Part A (ACR Convergence 2026) - P2/3 | "The primary endpoint was met and participants on LITI demonstrated continuous improvement in CLA-IGA-R response rates through Week 52. Results from CGA-Skin and SGA-Skin showed that more clinicians and participants rated skin signs as 'much better/moderately better' in the LITI group vs the PBO group at Week 24; by Week 52, improvements in skin signs were observed in both groups (LITI-LITI and PBO-LITI)."

Clinical • P2 data • Alopecia • Cutaneous Lupus Erythematosus • Immunology • Inflammatory Arthritis • Lupus

EMERALD: A Study to Learn More About the Long-Term Safety of Litifilimab (BIIB059) Injections and it's Effects on Symptoms in Adults With Systemic Lupus Erythematosus (SLE) (clinicaltrials.gov) - P3 | N=864 | Enrolling by invitation | Sponsor: Biogen | Trial completion date: Mar 2030 ➔ May 2032 | Trial primary completion date: Mar 2030 ➔ May 2032

Trial completion date • Trial primary completion date • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Defining Clinically Meaningful Change in Cutaneous Lupus Erythematosus Disease Area and Severity Index-Activity (CLASI-A) Scores: Data from AMETHYST Part A, a Phase 2 Study of Litifilimab in Cutaneous Lupus Erythematosus (EADV 2026) - No abstract available

Clinical • P2 data • Cutaneous Lupus Erythematosus • Immunology • Inflammatory Arthritis • Lupus

Characterization of Litifilimab Treatment Response in Patients with Cutaneous Lupus Erythematosus using RNA-seq from Lilac Phase 2 Part B Blood Samples (EADV 2026) - No abstract available

Clinical • P2 data • Cutaneous Lupus Erythematosus • Immunology • Inflammatory Arthritis • Lupus

Efficacy and Safety of Litifilimab in Cutaneous Lupus Erythematosus (CLE): 52-week results of the Phase 2 Study, AMETHYST Part A (EADV 2026) - No abstract available

Clinical • P2 data • Cutaneous Lupus Erythematosus • Immunology • Inflammatory Arthritis • Lupus

Recent recommendations for the treatment of lupus erythematosus (EADV 2026) - "For limited disease, topical corticosteroids and topical calcineurin inhibitors (tacrolimus, pimecrolimus) are standard; however, recent guidance increasingly favors calcineurin inhibitors or emerging topical Janus kinase (JAK) inhibitors for long-term maintenance to avoid corticosteroid-induced skin atrophy. For widespread, severe, or topically refractory CLE, systemic antimalarials—specifically hydroxychloroquine—remain the undisputed gold-standard first-line systemic intervention...When antimalarials fail, current algorithms prioritize the prompt introduction of second-line conventional immunosuppressants (methotrexate, mycophenolate mofetil, dapsone, or oral retinoids) to accelerate systemic glucocorticoid tapering. A key mandate in modern guidelines is the rapid reduction of prednisone to 5 mg/day or less within six months of initiation...The B-cell inhibitor belimumab and the type I interferon receptor antagonist anifrolumab are advised for patients with severe..."

Cutaneous Lupus Erythematosus • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Ophthalmology • Tobacco Cessation • IFNAR2 • TYK2

Modern Therapies for Discoid Lupus Erythematosus: A Narrative Review. (PubMed, Dermatol Ther (Heidelb)) - "Ongoing advances in understanding the immune mechanisms underlying DLE are shaping a transition from broad immunosuppression toward more targeted treatment strategies. Integrating newer biologic and small-molecule therapies with conventional management may offer improved control and better long-term outcomes for patients with chronic disease."

Journal • Review • Alopecia • Cutaneous Lupus Erythematosus • Discoid Lupus Erythematosus • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • TYK2

Targeted therapies against type I interferon and TNF-alpha in cutaneous lupus erythematosus: A systematic review of randomized trials. (PubMed, Dermatol Online J) - "Anifrolumab showed significant benefit in TULIP-2 (CLASI-50: 49% vs 25%; P = .001) and MUSE (63% vs 30.8%). Sifalimumab achieved CLASI-50 responses up to 73%. Deucravacitinib (TYK2 inhibitor) and BIIB059 (anti-BDCA2) also showed clinical improvements. RSLV-132 and epratuzumab did not demonstrate efficacy...Evidence for anti-TNF therapies remains insufficient. Further trials stratified by CLE subtype and patient-reported outcomes are warranted to inform clinical guidelines."

Journal • Review • Cutaneous Lupus Erythematosus • Herpes Zoster • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Oncology • Systemic Lupus Erythematosus • Varicella Zoster • TNFA • TYK2

Advances in the treatment of systemic lupus erythematosus: Biologicals, small-molecular agents, and cell-depleting therapies coming to the clinic. (PubMed, J Intern Med) - "Over the past few years, several new biological therapeutics have been approved for the treatment of SLE (belimumab and anifrolumab) or specifically for its renal organ manifestation (obinutuzumab), along with one new small molecular treatment for the latter (voclosporin). Several additional biologicals (litifilimab and dapirolizumab) and small molecules (deucravacitinib, upadacitinib, and cerenimod) are in late-stage clinical development...A reasonable expectation is that in the coming 1-2 years, several additional biologicals and small-molecular agents will be approved for the treatment of lupus. The most important conclusion is that the future for our patients with lupus looks brighter than ever before."

Journal • Review • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Litifilimab: Presentation of 52-week data from P2 portion of AMETHYST trial (NCT05531565) for CLE at EADV (Sep 30- Oct 3, 2026) (Biogen) - Q2 2026 Results: Data readout from P3 portion of AMETHYST trial in H1 2027

P2 data • P3 data • Cutaneous Lupus Erythematosus • Lupus

AMETHYST: A 2-Part Study to Learn Whether Litifilimab (BIIB059) Injections Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus (clinicaltrials.gov) - P2/3 | N=450 | Recruiting | Sponsor: Biogen | N=217 ➔ 450

Enrollment change • Cutaneous Lupus Erythematosus • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus

AMETHYST: A 2-Part Study to Learn Whether Litifilimab (BIIB059) Injections Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus (clinicaltrials.gov) - P2/3 | N=450 | Active, not recruiting | Sponsor: Biogen | Recruiting ➔ Active, not recruiting

Enrollment closed • Cutaneous Lupus Erythematosus • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus

A Study to Assess the Efficacy and Safety of BIIB059 in Participants With Active Subacute Cutaneous Lupus Erythematosus (SCLE) and/or Chronic Cutaneous Lupus Erythematosus (CCLE) With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy (clinicaltrials.gov) - P2/3 | N=474 | Recruiting | Sponsor: Biogen | Not yet recruiting ➔ Recruiting

Enrollment open • Cutaneous Lupus Erythematosus • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus

A Study to Assess the Efficacy and Safety of BIIB059 (Litifilimab) in Participants With Active Subacute Cutaneous Lupus Erythematosus (SCLE) and/or Chronic Cutaneous Lupus Erythematosus (CCLE) With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy (clinicaltrials.gov) - P2/3 | N=474 | Recruiting | Sponsor: Biogen | Trial completion date: Dec 2026 ➔ Dec 2027 | Trial primary completion date: Jul 2026 ➔ Oct 2026

Trial completion date • Trial primary completion date • Cutaneous Lupus Erythematosus • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus

A Study to Assess the Efficacy and Safety of BIIB059 in Participants With Active Subacute Cutaneous Lupus Erythematosus (SCLE) and/or Chronic Cutaneous Lupus Erythematosus (CCLE) With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy (clinicaltrials.gov) - P2/3 | N=474 | Not yet recruiting | Sponsor: Biogen

New P2/3 trial • Cutaneous Lupus Erythematosus • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus

Litifilimab demonstrates clinically meaningful improvements in cutaneous lupus erythematosus (CLE) disease activity over 24 weeks and is well-tolerated, supporting its continued evaluation in phase 3 studies, according to study results presented at the European Alliance of Associations for Rheumatology (EULAR) Congress 2026 (Rheumatology Advisor) - "Litifilimab treatment resulted in higher rates of clear or almost clear skin based on the CLA-IGA-R erythema assessment at both week 16 and week 24. At week 16, 14.7% of the litifilimab group achieved the primary endpoint compared with 2.9% of placebo participants, while corresponding response rates at week 24 were 19.0% and 4.2%, respectively. Improvements in CLASI-50 responses were also greater with litifilimab, with 40.8% of the litifilimab group achieving an at least a 50% reduction in CLASI scores at week 24 vs 21.0% in the placebo group. Separation between treatment groups was observed as early as week 4."

P3 data • Cutaneous Lupus Erythematosus

Exposure-Response Relationship Between Litifilimab and Clinical Outcomes in Systemic Lupus Erythematosus Populations (EULAR 2026) - P2, P3 | "Conclusions The ER models described the Phase 2 SLE data well offering a quantitative tool to characterize dose and efficacy for litifilimab in the treatment of SLE. Currently, litifilimab is being tested in Phase 3 (NCT04895241, NCT04961567)."

Clinical • Clinical data • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Validation of Cutaneous Lupus Erythematosus Disease Area and Severity Index-Activity (CLASI-A) For Evaluation of Patients With Cutaneous Lupus Erythematosus in Clinical Trials (EULAR 2026) - P2 | "Although the content validity of the CLASI-A is well-supported,1,2 and it has been used by physicians in multiple clinical studies, its broader psychometric properties (including construct validity, reliability, and responsiveness) remain under-evaluated in large-scale clinical study populations.2,3 Objectives To assess the psychometric properties of the CLASI-A using data from Part B of LILAC (NCT02847598), a two- part, Phase 2, randomized, double-blind, placebo-controlled study of litifilimab.4 Methods Psychometric properties of the CLASI-A were evaluated using data from LILAC Part B, which included 132 patients with CLE, and standard methodology...The magnitude of changes in CLASI-A increased with greater changes in these measures, with the CLASI-A able to detect significant within-group changes (change over time in a given group) in all improved categories (P<0.0001 for PGIC-CLE, P<0.01 for PGA-CLE Skin Activity), as well as change between the ‘much..."

Clinical • Cutaneous Lupus Erythematosus • Immunology • Inflammatory Arthritis • Lupus

Pharmacokinetics-Interferon Gene Signature (IGS) and IGS-Efficacy Relationships of Litifilimab in Participants With Systemic Lupus Erythematosus and Cutaneous Lupus (EULAR 2026) - P1, P2 | "Limitations include small sample sizes and the predominance of individuals with baseline IGS-high (over 80%). Further studies in larger SLE and CLE cohorts are warranted to refine PK-IGS and IGS-efficacy relationships of litifilimab."

Clinical • Gene Signature • PK/PD data • Cutaneous Lupus Erythematosus • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Litifilimab Improves Cutaneous Lupus Erythematosus Disease Activity: 24-Week CLASI-A Change from Baseline in AMETHYST Part A (EULAR 2026) - P2/3 | "Conclusions These 24-week results demonstrate that litifilimab achieved meaningful improvements in CLASI-A scores from baseline, supporting the pivotal CLA-IGA-R related endpoint and the secondary CLASI-A responder rates. These efficacy outcomes, together with the safety profile consistent with previous studies, support the ongoing evaluation of litifilimab in AMETHYST Part B (Phase 3) for CLE."

Alopecia • Cutaneous Lupus Erythematosus • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Litifilimab: Regulatory submission in US for SLE/CLE in 2027 (Royalty Pharma) - Q1 2026 Results

FDA filing • Cutaneous Lupus Erythematosus • Lupus • Systemic Lupus Erythematosus

Genetic Polymorphisms in Systemic Lupus Erythematosus and Their Clinical Implications: A Narrative Review. (PubMed, Int J Mol Sci) - "Progress in targeted therapy signifies a transition to personalized medicine with medications such as anifrolumab, litifilimab, iberdomide and Janus kinase (JAK) or Cyclin-Dependent Kinase (CDK) inhibitors, demonstrating potential for targeting pathways associated with the interferon gene signature and STAT4 polymorphisms. Notwithstanding the problems presented by the heterogeneity of SLE, the identification of risk variations is anticipated to enhance predictive and therapeutic biomarkers, hence facilitating more precise and individualized disease management."

Journal • Review • Glomerulonephritis • Immunology • Inflammation • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Psychiatry • Systemic Lupus Erythematosus • IRF5 • STAT4 • TLR7

Litifilimab: Data from P3 TOPAZ-1 trial (NCT04895241) for SLE in Q4 2026 (Biogen) - Q1 2026 Results: Data from P3 TOPAZ-2 trial (NCT04961567) for SLE in Q4 2026

P3 data • Lupus • Systemic Lupus Erythematosus

Therapeutic Approaches for Cutaneous Lupus Erythematosus: a Changing Landscape of Clinical Trials. (PubMed, J Inflamm Res) - "Existing SLE drugs such as belimumab and anifrolumab have shown potential promise as a treatment for CLE, and a Phase III CLE clinical trial for anifrolumab is ongoing. Other emerging therapies such as deucravacitinib, litifilimab, and enpatoran have been successful with skin-related endpoints in Phase II CLE trials...As CLASI has become an accepted primary endpoint for clinical trials, drug development is shifting to prioritize cutaneous outcomes and to use endpoints that measure skin-specific effects. This targeted approach represents a fundamental change that may ultimately increase FDA-approved therapies specifically for CLE and expand treatment options for patients with CLE."

Journal • Review • Cutaneous Lupus Erythematosus • Dermatology • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus