Simponi approved for early dose optimization for UC in Europe

The European Commission approved Simponi for early dose optimization for treating patients with ulcerative colitis who do not experience a satisfactory response to induction therapy, according to a press release issued by the manufacturer, MSD — known as Merck in the United States.

The company said the decision will allow more patients on Simponi (golimumab) therapy to achieve their desired clinical response.

“The European Commission approval of early dose optimization of golimumab for ulcerative colitis patients not adequately responding to induction is an important milestone for these patients and their gastroenterologists,” Björn Oddens, MD, PhD, vice president general medicine medical affairs at MSD, said in the press release.

During maintenance therapy, the drug is currently approved for a 100-mg dose every four weeks in patients weighing more than 80 kg and 50 mg every four weeks in patients weighing less than 80 kg. The approval will allow patients weighing less than 80 kg to increase their dose to 100 mg if they do not achieve a response at induction.

The approval was based on a post-hoc analysis of the PURSUIT induction and maintenance studies that found a trend toward greater clinical benefit of 100 mg of golimumab compared with 50 mg with increasing body weight.

“We are pleased that with early dose optimization of golimumab, more patients achieve the full long-term clinical, endoscopic, and quality of life benefits from golimumab treatment,” Oddens said in the press release.

Disclosures: Oddens is employed by MSD.

The European Commission approved Simponi for early dose optimization for treating patients with ulcerative colitis who do not experience a satisfactory response to induction therapy, according to a press release issued by the manufacturer, MSD — known as Merck in the United States.

The company said the decision will allow more patients on Simponi (golimumab) therapy to achieve their desired clinical response.

“The European Commission approval of early dose optimization of golimumab for ulcerative colitis patients not adequately responding to induction is an important milestone for these patients and their gastroenterologists,” Björn Oddens, MD, PhD, vice president general medicine medical affairs at MSD, said in the press release.

During maintenance therapy, the drug is currently approved for a 100-mg dose every four weeks in patients weighing more than 80 kg and 50 mg every four weeks in patients weighing less than 80 kg. The approval will allow patients weighing less than 80 kg to increase their dose to 100 mg if they do not achieve a response at induction.

The approval was based on a post-hoc analysis of the PURSUIT induction and maintenance studies that found a trend toward greater clinical benefit of 100 mg of golimumab compared with 50 mg with increasing body weight.

“We are pleased that with early dose optimization of golimumab, more patients achieve the full long-term clinical, endoscopic, and quality of life benefits from golimumab treatment,” Oddens said in the press release.

Disclosures: Oddens is employed by MSD.

    Perspective

    Stephen B. Hanauer

    The recent European Commission decision approving early dose optimization with golimumab for patients with ulcerative colitis based on a post-hoc analysis of the PURSUIT induction and maintenance studies is somewhat a departure from typical regulatory approvals allowing post-hoc analysis that often impact clinical care vs. the primary endpoints in trials that lead to initial regulatory approvals. The requisites for dose escalation in patients with ulcerative colitis reflect the higher doses needed to treat moderate-severely active IBD compared with dosing in other immune mediated inflammatory disorders (such as psoriasis, another approved indication for golimumab). In many IBD scenarios, clinical practice, post-approval investigator-initiated trials, and case series have demonstrated a frequent need to increase doses, particularly in patients with more extensive or severe disease. These observations also reflect a need for improved therapeutic drug monitoring to improve clinical outcomes and to prevent loss of response due to low drug levels due to rapid clearance, including increased clearance due to an abundance of target (eg, high TNF levels) or development of anti-drug antibodies.

    • Stephen B. Hanauer, MD
    • Clifford Joseph Barborka Professor of Medicine
      Northwestern University Feinberg School of Medicine
      Medical Director, Digestive Health Center

    Disclosures: Hanauer reports financial relationships with AbbVie, Actavis, Amgen, Arena, Astellas, Boehringer-Ingelheim, Bristol-Myers Squibb, Cubist, Ferring, Genentech, Gilead, GlaxoSmithKline and Janssen.

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