Patients & Caregivers

Areas of Focus

Progressing Innovative Treatment Options for Autoimmune Disease

• Immunoglobulin G4-related Disease (IgG4-RD)

  IgG4-RD is a chronic fibro-inflammatory condition that can affect virtually all organ systems, including the pancreas, biliary tract, salivary and lacrimal glands, lungs and kidneys. IgG4-RD is a relatively recently described disease that incorporates groups of manifestations that were diagnosed as separate disease entities prior to 2003.

  Patients with IgG4-RD may present with a single organ involved but more frequently present with multiple organ involvement. As the disease progresses and patients experience new or worsening symptoms (i.e., flares), lesions develop in additional organs and the cellular inflammation characterizing early disease moves toward a more fibrotic stage, which can lead to major irreversible tissue damage and ultimately organ failure.

  Despite the growing recognition of IgG4-RD and advances in the understanding of its pathophysiology, treatment options are limited. Glucocorticoids (GCs), while not approved, are commonly used to treat disease flares. Although GC treatment is initially effective, long-term treatment can often result in various complications and co-morbidities. GCs do not address underlying disease activity that can meaningfully contribute to organ fibrosis, damage, and failure. Most patients treated with GCs relapse within 12 months of discontinuing GC treatment, and maintenance therapy with GCs has not been shown to prevent recurrence of disease.

  The pathogenesis of IgG4-RD suggests that B cell-targeted therapies may provide therapeutic benefit. With only one B cell depleting agent currently approved to treat IgG4-RD in the U.S., there remains a pressing need for additional therapeutic strategies.

  The currently diagnosed prevalence of IgG4-RD patients in the United States is approximately 20,000, with comparable prevalence rates globally.¹

• Multiple Sclerosis (MS)

  MS is the most common immune-mediated, chronic inflammatory demyelinating disease of the central nervous system. Symptoms include sensory and visual disturbances, coordination impairment and spasticity, fatigue, pain, weakness and cognitive deficits. B cell-directed therapies are highly effective in treating MS.

  Relapsing forms of MS are characterized by episodes of neurological dysfunction (relapses) followed by complete or incomplete recovery resulting in disease progression. Disease progression can also occur independently of relapse activity, a concept known as PIRA or “smoldering” disease.

  Progressive forms of MS, such as primary progressive MS (PPMS) and non-active secondary progressive MS (naSPMS), are defined by a steady accumulation of disability. While current approved therapies can modulate the peripheral immune system, they have limited impact on the chronic, compartmentalized inflammation within the central nervous system. This inflammation is a key driver of progression independent of relapses and represents a critical unmet need.

  MS affects over two million people worldwide, including greater than 650,000 people in the United States.²

• Systemic Lupus Erythematosus (SLE)

  SLE, the most common form of lupus, is a complex, chronic autoimmune disease characterized most notably by unpredictable flares in joints, skin, kidneys and other vital organs that cause progressive organ damage.

  SLE commonly affects the central nervous system, kidneys, gastrointestinal system, mucous membranes, heart, skin, hematologic system, musculoskeletal system and lungs. The majority of SLE cases occur in women, frequently starting at childbearing age. Comorbidities, such as infections, malignancies, hypertension, lipid disorders and diabetes, increase risk of patient disability and death. B cell-directed therapies are effective in treating SLE. The currently diagnosed prevalence of SLE (excluding lupus nephritis) in the United States is approximately 172,000, with comparable prevalence rates globally.³