Indication

Lialda is indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis (UC) and for the maintenance of remission of UC.

Important Safety Information

  • Lialda is contraindicated in patients with known hypersensitivity to salicylates or aminosalicylates or to any of the ingredients of Lialda.
  • Renal impairment, including minimal change nephropathy, acute and chronic interstitial nephritis, and, rarely, renal failure, has been reported with products such as Lialda that contain mesalamine or are converted to mesalamine. It is recommended that patients have an evaluation of renal function prior to initiating use of Lialda and periodically while on therapy. Exercise caution when using Lialda in patients with known renal dysfunction or a history of renal disease.

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For active, mild to moderate ulcerative colitis (UC)

Important Safety Information

Lialda is contraindicated in patients with known hypersensitivity to salicylates or aminosalicylates or to any of the ingredients of Lialda. See Important Safety Information

Lialda® (mesalamine): #1 Prescribed 5-ASA Among Gastroenterologists1

Lialda Efficacy

Lialda is indicated for the induction of remission in patients with active mild to moderate UC and for the maintenance of UC remission.

Induction of UC Remission

In two pivotal trials, Lialda induced remission of active, mild to moderate UC using clinical and endoscopic criteria.2,3*†‡

Kamm Study2

Kamm study findings on Lialda Kamm study findings on Lialda

Primary endpoint: % patients who achieved remission at week 82*†‡


Lichtenstein Study3

Kamm study findings on Lialda Kamm study findings on Lialda

Primary endpoint: % of patients who achieved REMISSION at week 83*†‡

*STUDY DESIGN: Patients with active, mild to moderate UC were included in two separate 8-week, randomized, double-blind, placebo-controlled trials. Data reflect the intent-to-treat population defined as all randomized subjects who received at least one dose of study medication.2,3

REMISSION: Defined as a modified Ulcerative Colitis Disease Activity Index (UC-DAI) of ≤1, with scores of 0 for both rectal bleeding and stool frequency, and a sigmoidoscopy score reduction of ≥1 point from baseline.2,3

SCORING CRITERIA: Modified UC-DAI2,3:

  • Rectal bleeding score: 0 (none), 1 (streaks of blood), 2 (obvious blood), or 3 (mostly blood)
  • Stool frequency score: 0 (normal), 1 (1-2 more than normal/day), 2 (3-4 more than normal/day), or 3 (>4 more than normal/day)
  • Sigmoidoscopic (mucosal) appearance score [friability score moved from 1/mild to 2/moderate]: 0 (normal), 1 (mild: no friability, erythema, minimal granularity, decreased vascular pattern), 2 (moderate: marked erythema, friability, granularity, bleeding with minimal trauma, absent vascular pattern, no ulcerations), or 3 (severe: ulceration, spontaneous bleeding)
  • Physician’s Global Assessment (PGA) score: 0 (no active disease), 1 (mild), 2 (moderate), or 3 (severe)

Important Safety Information:

  • Renal impairment, including minimal change nephropathy, acute and chronic interstitial nephritis, and, rarely, renal failure, has been reported with products such as Lialda that contain mesalamine or are converted to mesalamine. It is recommended that patients have an evaluation of renal function prior to initiating use of Lialda and periodically while on therapy. Exercise caution when using Lialda in patients with known renal dysfunction or a history of renal disease.

See continued Important Safety Information below.

Maintenance of UC Remission

In a non-inferiority trial, Lialda (mesalamine) helped maintain long-term endoscopic remission at 6 months in patients with ulcerative colitis.4§||¶

D'Haens Study4

D’Haens Study findings on Lialda D’Haens Study findings on Lialda

(95% CI for difference: -3.9%, 8.1%)

Primary endpoint: % of patients in ENDOSCOPIC REMISSION at month 64§||¶

§STUDY DESIGN: Patients with UC in remission were included in a 6-month, randomized, double-blind, multicenter, non-inferiority, active-comparator trial.4 Data reflect the per-protocol population defined as all subjects who received at least one dose of study medication and either completed the study or withdrew for reasons related to efficacy or adverse events, and who were without major protocol deviations.4

||ENDOSCOPIC REMISSION: Defined as a modified UC-DAI endoscopy subscore of ≤1. Scoring criteria for endoscopic (mucosal) appearance: 0 (normal), 1 (mild: no friability, erythema, minimal granularity, decreased vascular pattern), 2 (moderate: marked erythema, friability, granularity, bleeding with minimal trauma, absent vascular pattern, no ulcerations), or 3 (severe: ulceration, spontaneous bleeding).4

DOSING: Lialda (mesalamine) was dosed at 2.4 g/day once daily. Active-comparator was delayed-release mesalamine dosed at 1.6 g/day (0.8 g twice daily).4

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