Healthcare Professionals

What is Adacolumn

  • Adacolumn® is a unique medical device system for selective leukocyte apheresis.
  • GMDN code: Class IIb
  • Single use, sterile disposable

Adacolumn, current CE label indication

  • Induction of remission in patients with inflammatory bowel disease (active UC and CD)
  • Suppressing subjective and objective symptoms in patients with rheumatoid arthritis (RA) in the inflammatory stage whose symptoms might be resistant to standard drug therapy
  • Treatment of patients with ocular Behçet disease
  • Treatment of patients with systemic lupus erythematosus (SLE)
  • Improvement of the clinical symptoms in patients with pustular psoriasis

Which IBD patients can benefit from Adacolumn?

Patient profiles

Mild to moderate

  • Active UC, mild to moderate and
  • Steroid-dependent or
  • Steroid-resistant
  • GMA can also be used as alternative in cases of major contraindications to steroids (e.g. diabetes, hypertension and glaucoma)
  • ... or as "bridging therapy" when escalated to immunosuppression until AZA/6MP efficacy levels, (3-12 months) are reached
  • Achieving 72% clinical remission at week 12. 4

1 Shimoyama, Hanai, Nakamura, Bresci, Maiden, Sands 1999-2008

2 Habermalz 2008, Zhu 2011

3 Thanaraj 2010

4 Passalacqua S, et al. J Clin Apher 2011; 26(6):332-337.

Moderate to severe

  • Mild to moderate disease activity (CAI 5-12) 5
  • Steroid dependent or resistant
  • Azathioprine/6-MP failure, and/or
  • Azathioprine refractory or intolerant
  • GMA can also be used where immunosuppression or biologics are contraindicated
  • ... or as "bridging therapy" when escalated to biologics
  • Achieving 68% clinical response at week 8 and 37% steroid-free clinical remission at week 12

5 Cabriada JL, et al. J Gastroenterol 2012;47(4):359 -365.

Refractory Profile

  • Moderate to severe active UC
  • Steroid dependent or resistant, with
  • Insufficient response or intolerance to azathioprine/6-MP, and/or
  • Insufficient response or intolerance to biologics
  • GMA can be used after having failed immunosuppression and/or biologics
  • ... or when treatment with immunosuppression or biologics is contraindicated
  • 12 week interim results demonstrate 55.9 % response and 39.3% remission

6 Dignass A, et.al. J Crohns Colitis 2014;8:S276.

The mechanisms

Adacolumn MoA video

Long term outcomes in UC

Maintenance Practice Today

  • Maintenance on demand: Calprotectin-triggered1
  • Scheduled maintenance (ULTRA scheme, 1 x eow/1 year)2
  • Re-treatment of flare3
  • Empirically scheduled maintenance: 6 treatments/year

1 Maiden L, et al. Inflamm Bowel Dis 2008

2 L.Sandborn WJ, et al. Gastroenterol and Hepatol 2013

3 Lindberg A, et al. BMC Gastroenterol

SIMAC - Results

  • 142 UC patients from 23 centres
  • 70 % RETROSPECTIVE (data collected prospectivelly)- 30 % PROSPECTIVE2
  • Mean age: 40 ± 14
  • Median time from UC diagnosis in months: 42 (22-82)

Long-term REMISSION among initial responders % (n=132)

Italian long-term clinical experience

  • Observational study to evaluate the 24-month efficacy of Adacolumn in patients included in the Italian Registry
  • 347 patients (214 males; 0 46.3 years; CAI 7.47)
  • 288 patients steroid-resistant or steroid-dependant
  • Mild-moderate UC; All patients had failed on mesalazine and were in treatment with steroids
  • GMA standard protocol (5 sessions in 5 weeks)
  • Clinical evaluations at 3, 12 and 24 months since the completion of GMA
  • Endpoints: Clinical remission(CAI < 4), ESR, CRP, WBC, Endoscopic remission (EAI 0/1) at 3 months

Incidence of clinical remission

Endoscopy and safety

  • Endoscopic data were available for 107 patients.
  • The incidence of mucosal healing was 47%
  • All patients with mucosal healing maintained clinical remission for the entire follow-up
  • No relevant adverse effects were observed
  • GMA has an excellent longterm safety profile.
  • Late induction of clinical remission may occur in up to 50% of those patients with initial partial response to GMA.
  • GMA-induced clinical remission is associated with endoscopic remission in almost all cases.

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