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.
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.
Biogen announced that litifilimab received FDA Breakthrough Therapy Designation for cutaneous lupus erythematosus and will present Phase 2 AMETHYST study results at the 2026 AAD Annual Meeting, with Phase 3 data expected in 2027.
Obinutuzumab demonstrated superior efficacy in two separate phase 3 trials for systemic lupus erythematosus and primary membranous nephropathy, with statistically significant improvements in remission rates and disease response measures.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07607964 |
A Study to Assess Adverse Events, How the Drug Moves Through the Body and Effectiveness of Intravenous Infusions and Subcutaneous Injections of ABBV-519 in Adult Participants With Systemic Lupus Erythematosus (SLE) or Rheumatoid Arthritis (RA) |
RECRUITING | PHASE1 |
| NCT07598396 |
A Study to Evaluate Mosunetuzumab in Participants With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis |
RECRUITING | PHASE2 |
| NCT07570862 |
A Phase 2, Open-Label, Single-Arm Trial of FT819 in Participants With Lupus Nephritis |
NOT_YET_RECRUITING | PHASE2 |
| NCT07558850 |
Exploratory Clinical Study of Anti-CD19/BCMA Universal CAR-T Cell Injection for the Treatment of Refractory Autoimmune Diseases |
RECRUITING | NA |
| NCT07526350 |
MTS109 in Patients With Refractory Autoimmune Diseases |
RECRUITING | EARLY_PHASE1 |
| NCT07523282 |
Safety and Preliminary Efficacy of HN2302 in Patients With Autoimmune Diseases |
NOT_YET_RECRUITING | PHASE1 |
| NCT07517536 |
CHT105 for the Treatment of Refractory Lupus Nephritis |
NOT_YET_RECRUITING | NA |
| NCT07515638 |
Immun4Cure Cohort of Autoimmune Diseases |
NOT_YET_RECRUITING | |
| NCT07515014 |
A Study of E6742 in Participants With Systemic Lupus Erythematosus |
RECRUITING | PHASE2 |
| NCT07509892 |
A Clinical Trial on the Efficacy and Safety of TQH3906 in the Treatment of Systemic Lupus Erythematosus |
NOT_YET_RECRUITING | PHASE2 |
