Sjögren's Disease

Sjögren’s Disease is a chronic autoimmune disease causing dry eyes and mouth, with sicca symptoms scattered across ophthalmology, dentistry and rheumatology so the underlying systemic cause often goes unrecognised.
About Sjögren's Disease

In numbers

  • A global meta-analysis pools incidence at 6.9 new cases per 100,000 person years.
  • Prevalence estimates vary widely by methodology, with population-based studies applying strict classification criteria consistently reporting lower figures than broader symptom-based estimates.
  • That gap between strict and symptom-based estimates points to substantial under-diagnosis in the community.

Special details

  • Women are affected roughly nine times more often than men, one of the strongest sex skews seen in any systemic autoimmune disease.
  • The disease typically presents in middle age, with a mean age at diagnosis of around 56 years.
  • Onset falls in the same midlife window in which dry eyes, dry mouth and fatigue are most often dismissed as menopausal or age-related.
Signs and symptoms of Sjögren's Disease
Diagnosis commonly takes several years from first symptoms, since sicca complaints are dismissed as trivial or age-related and patients move between ophthalmology, dentistry and general practice without a unifying assessment.
Dry eyes and mouth

Dry eyes and mouth

Persistent gritty eyes and dry mouth with difficulty swallowing, dental decay and oral thrush define the core sicca complex.

Fatigue and joint pain

Fatigue and joint pain

Profound fatigue and arthralgia affect almost all patients and are often disabling day to day.

Systemic organ involvement

Systemic organ involvement

Around one third of patients develop lung, kidney, nerve or skin disease beyond the glands.

Raynaud's and vasculitis

Raynaud's and vasculitis

Circulation changes in the fingers and skin vasculitis signal more active systemic disease.

Lymphoma risk

Lymphoma risk

Sustained B-cell activity gives Sjögren's the highest lymphoma risk of any autoimmune disease, chiefly MALT lymphoma.

Key challenges from product development to launch

Strategy and Business

Strategy and Business

  • The wrong disease or indication selected for investment
  • Indications tackled in the wrong order due to shaky success estimates
  • R&D returns slipping below the cost of capital
Clinical Development

Clinical Development

  • Trials delayed by low patient recruitment
  • High screen-failure rates that raise trial cost
  • Mixed cohorts that make the signals difficult to detect
HEOR, Access & Value

HEOR, Access & Value

  • A value case that arrives too late or is underdeveloped
  • Eligible population under-counted, budget-impact case unsubstantiated
  • Approved by the regulator, delayed at HTA
Medical Affairs

Medical Affairs

  • Fragmented, differently-coded healthcare data
  • Diagnostic delay that is long and unequal
  • No shared evidence base across functions
Launch and Commercial

Launch and Commercial

  • Launch planned without a view of the number of findable patients
  • Targeting too broad a population slows early uptake
  • RWE started too late to build the case

How Volv Global Helps

The earliest pipeline decisions carry lasting consequences: the wrong indication chosen, indications pursued in the wrong order, or capital committed where expected returns already trail its cost. Mistakes made this early are expensive to correct later.

A launch planned without a view of findable patients is poorly resourced from day one. Targeting too broad a population slows early uptake, and real-world evidence gathered too late leaves little time to build a strong access dossier.

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