Systemic lupus erythematosus is the most common type of lupus and is a chronic systemic autoimmune disease that can involve multiple organs. Disease burden is higher in women and in some racial and ethnic groups.
Alumis reported that 54% of psoriasis patients achieved complete skin clearance (PASI 100) at 48 weeks in the ONWARD3 study, with 75% achieving PASI 90. The company plans to submit an NDA for envudeucitinib in Q4 2026.
CAR-T therapy reaches 150 patients in Ireland and expands into autoimmune trials for lupus and MS. Kyverna's miv-cel nears FDA approval for stiff person syndrome, and new research links gene variants to CAR-T outcomes.
Phase I CARLYSLE trial data show CAR-T therapy obe-cel induces remission in severe refractory lupus with a favorable safety profile. Separate case report documents two successful pregnancies after dual-target CAR-T therapy with no transmission to infants.
A phase IIb trial demonstrated that low-dose IL-2 therapy produced dose-dependent improvements in SLE patients, with 69.7% achieving SRI-4 response at the highest dose versus 23.5% on placebo. A separate systematic review found IL-17 inhibitors remain potential SLE treatment options, though efficacy data are limited.
CRISPR Therapeutics said CASGEVY launch momentum is building and multiple pipeline assets could generate data in the next 12 to 18 months. The company also highlighted zugo-cel progress in oncology and autoimmune disease.
AbbVie raised 2026 revenue and EPS guidance after first-quarter results beat estimates, with Skyrizi and Rinvoq driving growth. Humira erosion continued as neuroscience, oncology and pipeline assets supported the outlook.
The FDA approved AstraZeneca’s Saphnelo Pen for once-weekly self-administration in adults with systemic lupus erythematosus. Approval was based on Phase III TULIP-SC results showing reduced disease activity versus placebo.
January and March 2026 drug pipeline updates included Phase 3 results, Fast Track designations and Priority Review decisions across multiple disease areas. Mavacamten, teplizumab-mzwv, anifrolumab, AXS-05, gedatolisib and AFTX-201 were among the programs with notable milestones.
GRI Bio discussed positive Phase 2a idiopathic pulmonary fibrosis data for GRI-0621, highlighting biomarker results indicating improvements in fibrosis and lung repair.
AbbVie said Skyrizi and Rinvoq generated $26.0 billion in 2025 sales and are expected to exceed $31 billion in 2026. The company said the two immunology drugs continue to offset Humira erosion and drive top-line growth.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07782450 |
A Study to Learn About a Medicine Called PF-08154225 in Participants With Autoimmune Diseases |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT07780045 |
SII and SIRI as Prognostic Biomarkers in Lupus Nephritis |
NOT_YET_RECRUITING | |
| NCT07778446 |
A Study to Test CRT-402 in Refractory Autoimmune Disease |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT07751315 |
A Study of QLS2404 Injection in Healthy Participants and Participants With Rheumatic Autoimmune Diseases |
NOT_YET_RECRUITING | PHASE1 |
| NCT07748156 |
SNC116 Therapy for Refractory Systemic Lupus Erythematosus |
NOT_YET_RECRUITING | EARLY_PHASE1 |
| NCT07732309 |
A Study of ATG-201 in Adult Participants With Autoimmune Diseases |
NOT_YET_RECRUITING | PHASE1 |
| NCT07688980 |
Study to Characterise Pharmacokinetics (PK), Pharmacodynamics (PD), and Safety of Anifrolumab Administered Subcutaneously (SC) or Intravenously (IV) |
NOT_YET_RECRUITING | PHASE1 |
| NCT07678203 |
Dapagliflozin to Reduce the Decline in Renal Function in Patients Newly Diagnosed With Lupus Nephritis |
ACTIVE_NOT_RECRUITING | PHASE1/PHASE2 |
| NCT07676266 |
A Study of C-CAR168 in the Treatment of Autoimmune Diseases Refractory to Standard Therapy |
NOT_YET_RECRUITING | PHASE1 |
| NCT07666711 |
Biomarker Development for Autoimmune Disorders Involving the Kidneys |
RECRUITING |
