NETWORK META-ANALYSIS OF APPROVED BIOLOGIC INTERVENTIONS FOR THE MAINTENANCE OF RESPONSE IN ULCERATIVE COLITIS

Author(s)

Chen M1;Black CM2;Gurunath S1;Jansen JP3;Chaudhary MA4, Fan T*5 1Mapi Group, Boston, NJ, USA, 2Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ, USA, 3Mapi / Tufts University School of Medicine, Boston, MA, USA, 4Merck

OBJECTIVES: To evaluate the comparative long-term efficacy of approved biologic treatments for ulcerative colitis (UC), with a focus on golimumab(GOL), adalimumab(ADA), and infliximab(IFX). METHODS: A systematic literature review identified 4 randomized controlled trials (RCTs) assessing the efficacy of IFX (5mg, 10mg), ADA (160/80/40mg) and GOL (100mg, 50mg) as maintenance treatment for moderate to severe UC. Data were extracted on study design and patient characteristics. Endpoints concerning efficacy were evaluated using network meta-analyses (NMA) within a Bayesian framework. Analyses were conducted to evaluate sustained response to therapy at both the mid-point (week 30/36) and completion (week 52/54/60) of each trial. An additional sub-analysis was conducted because the PURSUIT trial design included a re-randomization of induction responders to placebo, GOL 50mg or GOL 100mg. This sub-analysis was limited to patients who received an induction regimen of GOL 200/100mg followed by 100mg during the maintenance period and induction non-responders who received 100mg as per protocol. All analyses were conducted using the OpenBUGS software package. RESULTS: 4 RCTs were identified from the literature. Overall, IFX and GOL showed greater sustained response, remission and mucosal healing when compared to ADA 160/80/40mg. Between IFX and GOL, IFX doses showed greater remission at trial’s completion (IFX5mg OR=2.04, 95%Crl 0.6-7.03; IFX10mg 1.96, 0.6-6.8; GOL50mg 1.24, 0.4-3.9; GOL100mg 1.79, 0.6-5.4), response (IFX5mg 1.88,0.8-4.4; IFX10mg 1.73, 0.7-4.1; GOL50mg, 1.38, 0.6-3.1; GOL100mg 1.45, 0.6-3.3) and mucosal healing (IFX5mg 1.51,0.7-3.4; IFX10mg 1.53, 0.7-3.5; GOL50mg, 1.38, 0.6-3.3; GOL100mg 1.38, 0.6-3.2. During the sub-analyses, GOL100mg and both IFX doses demonstrated greater sustained response and sustained remission when compared to ADA 160/80/40mg. Sustained mucosal response increased for IFX 5mg and IFX10mg but decreased for GOL100mg. CONCLUSIONS: Based on indirect comparison of RCT evidence, IFX and GOL are more efficacious to induce and maintain long term response than ADA among moderate to severe UC patients.

Conference/Value in Health Info

2013-11, ISPOR Europe 2013, The Convention Centre Dublin

Value in Health, Vol. 16, No. 7 (November 2013)

Code

PGI5

Topic

Clinical Outcomes

Topic Subcategory

Comparative Effectiveness or Efficacy

Disease

Gastrointestinal Disorders

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