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. 2016 Apr 28;7(4):e168.
doi: 10.1038/ctg.2016.24.

Maintenance of Efficacy and Continuing Safety of Golimumab for Active Ulcerative Colitis: PURSUIT-SC Maintenance Study Extension Through 1 Year

Peter R Gibson  1 , Brian G Feagan  2 , William J Sandborn  3 , Colleen Marano  4 , Richard Strauss  4 , Jewel Johanns  4 , Lakshmi Padgett  4 , Judith Collins  5 , Dino Tarabar  6 , Zbigniew Hebzda  7 , Paul Rutgeerts  8 , Walter Reinisch  9   10
Affiliations

Maintenance of Efficacy and Continuing Safety of Golimumab for Active Ulcerative Colitis: PURSUIT-SC Maintenance Study Extension Through 1 Year

Peter R Gibson et al. Clin Transl Gastroenterol. .

Abstract

Objectives: The safety and efficacy of subcutaneous golimumab through 2 years of maintenance therapy was evaluated in patients with moderate-to-severe ulcerative colitis (UC).

Methods: Patients completing treatment through week 52 (placebo, golimumab 50, 100, every-4-weeks (q4w)) and evaluations at week 54 were eligible for this long-term extension (LTE) trial. Patients receiving placebo or golimumab 50 mg with worsening disease during the LTE could receive golimumab 100 mg. Efficacy assessments included the Mayo physician's global assessment (PGA) subscore, inflammatory bowel disease questionnaire (IBDQ), and corticosteroid use. Patients who were randomized to golimumab at PURSUIT-Maintenance baseline and continued receiving golimumab during the LTE were analyzed for efficacy (using intention-to-treat and "as observed" analyses; N=195) and safety (N=200). Patients treated with golimumab at any time from induction baseline through week 104 (N=1240) constituted the overall safety population.

Results: Baseline demographics and disease characteristics of patients entering the LTE receiving golimumab were similar to those of all patients randomized to golimumab maintenance at baseline. At week 104, 80.5% (157/195) of patients had a PGA=0/1 (range weeks 56-104: 80.5-91.8%) and 56.4% (110/195) had a PGA=0 (weeks 56-104: range: 53.8-58.5%). Through week 104, 86% of patients maintained inactive or mild disease activity. Among 174 corticosteroid-free patients at week 54, 88.5% remained corticosteroid-free at week 104. At week 104, 62.2% (120/193) had an IBDQ score ≥170. Tuberculosis, opportunistic infection, and malignancy rates were low, and the overall safety profile was similar to that reported through week 54. Two non-melanoma skin cancers, one metastatic colon cancer, and two deaths (biventricular heart dysfunction, sepsis) occurred between weeks 54 and 104.

Conclusion: Subcutaneous golimumab q4w through 2 years maintained clinical benefit and reduced corticosteroid use among patients who did well in the maintenance study. No new safety signals were observed.

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Conflict of interest statement

Guarantor of the article: Peter R. Gibson, MD.

Specific author contributions: P.R. Gibson, B.G. Feagan, W.J. Sandborn, J. Collins, D. Tarabar, Z. Hebzda, P. Rutgeerts, and W. Reinisch collected the data; L. Padgett and J. Johanns performed statistical analysis; all the authors contributed to the design of the study. All the authors contributed to the interpretation of data and critical review and revision of each draft of the manuscript. All the authors had access to the data and approved the final version for submission.

Financial support: Janssen Research & Development, LLC (Spring House, PA, USA) funded the study and analyses, and reviewed and approved the publication. Janssen Scientific Affairs, LLC (Horsham, PA, USA) provided writing support.

Potential competing interests: P.R. Gibson reports having received consulting fees from Ferring Pharmaceuticals, Janssen Research & Development, LLC, Shering-Plough, AbbVie, having received speaker fees from Ferring Pharmaceuticals, Janssen Research & Development, LLC, Abbott/AbbVie, Shering-Plough, and Fresenius Kabi, having received research support from Ferring Pharmaceuticals, Janssen Research & Development, LLC, Schering-Plough, AbbVie, Fresenius Kabi, and Norgine. B.G. Feagan reports having received consulting fees from Abbott/AbbVie, Actogenix, Albireo Pharma, Amgen, Astra Zeneca, Avaxia Biologics, Axcan, Baxter Healthcare, Boehringer-Ingelheim, Bristol-Myers Squibb, Calypso Biotech, Celgene, Elan/Biogen, EnGene, Ferring Pharma, Roche/Genentech, GiCare Pharma, Gilead, Given Imaging, GSK, Ironwood Pharma, Janssen Biotech (Centocor), Johnson & Johnson/Janssen Research & Development, LLC, Kyowa Kakko Kirin, Lexicon, Lilly, Merck, Millennium, Nektar, Novonordisk, Prometheus Therapeutics and Diagnostics, Pfizer, Receptos, Salix Pharma, Serono, Shire, Sigmoid Pharma, Synergy Pharma, Takeda, Teva Pharma, Tillotts, UCB Pharma, Vertex Pharma, Warner-Chilcott, Wyeth, Zealand, Zyngenia, having received speaker fees from Abbott/AbbVie, Johnson & Johnson/Janssen Research & Development, LLC, Takeda, Warner-Chilcott, UCB Pharma, having been a scientific advisory board member for Abbott/AbbVie, Amgen, Astra Zeneca, Avaxia Biologics, Bristol-Myers Squibb, Celgene, Centocor, Elan/Biogen, Ferring, Johnson & Johnson/Janssen Research & Development, LLC, Merck, Novartis, Novonordisk, Pfizer, Prometheus Laboratories, Salix Pharma, Takeda, Teva, Tillotts Pharma AG, UCB Pharma, and having received research support from Abbott/AbbVie, Amgen, Astra Zeneca, Bristol-Myers Squibb (BMS), Johnson & Johnson/Janssen Research & Development, LLC, Roche/Genentech, Millennium, Pfizer, Receptos, Santarus, Sanofi, Tillotts, UCB Pharma. W.J. Sandborn reports having received received consulting fees from Abbott, ActoGeniX NV, AGI Therapeutics, Alba Therapeutics, Albireo, Alfa Wasserman, Amgen, AM-Pharma BV, Anaphore, Astellas, Athersys, Atlantic Healthcare, Aptalis, BioBalance, Boehringer-Ingelheim, Bristol-Myers Squibb, Celgene, Celek Pharmaceuticals, CellerixSL, Cerimon Pharmaceuticals, ChemoCentryx, CoMentis, Cosmo Technologies, Coronado Biosciences, Cytokine Pharmasciences, Eagle Pharmaceuticals, EnGene, Eli Lilly, Enteromedics, Exagen Diagnostics, Ferring Pharmaceuticals, Flexio Therapeutics, Funxional Therapeutics, Genzyme, Gilead Sciences, Given Imaging, GlaxoSmithKline, Human Genome Sciences, Ironwood Pharmaceuticals, Janssen Research & Development, LLC, KaloBios Pharmaceuticals, Lexicon Pharmaceuticals, Lycera Corp, Meda Pharmaceuticals, Merck Research Laboratories, Merck Serono, Millenium Pharmaceuticals, Nisshin Kyorin Pharmaceuticals, Novo Nordisk, NPS Pharmaceuticals, Optimer Pharmaceuticals, Orexigen Therapeutics, PDL Biopharma, Pfizer, Procter and Gamble, Prometheus Laboratories, ProtAb, Purgenesis Technologies, Relypsa, Roche, Salient Pharmaceuticals, Salix Pharmaceuticals, Santarus, Schering Plough, Shire Pharmaceuticals, Sigmoid Pharma, Sirtris Pharmaceuticals, SLA Pharma UK, Targacept, Teva Pharmaceuticals, Therakos, Tilliotts Pharma AG, TxCell SA, UCB Pharma, Viamet Pharmaceuticals, Vascular Biogenics, Warner Chilcott UK, and Wyeth; has received research grants from Abbott, Bristol-Myers Squibb, Genentech, GlaxoSmithKline, Janssen Research & Development, LLC, Milennium Pharmaceuticals, Novartis, Pfizer, Procter and Gamble, Shire Pharmaceuticals, and UCB Pharma; has received payments for lectures/speakers bureau from Abbott, Bristol-Myers Squibb, and Janssen Research & Development, LLC; and holds stock/stock options in Enteromedics. J. Collins reports having received research funding from Janssen Research & Development, LLC, and UCB Pharma, and has served on the Speakers bureau for Salix. D. Tarabar reports no conflicts of interest. Z. Hebzda, reports no conflicts of interest. P. Rutgeerts reports having received research funding and/or served as a speaker, consultant, and/or advisory board member for Abbott Laboratories, Janssen Research & Development, LLC, Merck Research Laboratories, Merck Serono, UCB Pharma, Millenium/Takeda, Genentech/Hoffman LaRoche, Neovacs, Bristol Myers Squibb, Robarts, Tillotts, Pfizer, and Falk Pharma. W. Reinisch reports having served as a speaker, consultant, and/or advisory board member for Abbott Laboratories, Aesca, Amgen, Astellas, Astra Zeneca, Biogen IDEC, Bristol-Myers Squibb, Cellerix, Chemocentryx, Celgene, Janssen Research & Development, LLC, Danone Austria, Elan, Ferring, Genentech, Grünenthal, Johnson & Johnson, Kyowa Hakko Kirin Pharma, Lipid Therapeutics, Millenium, Mitsubishi Tanabe Pharma Corporation, MSD, Novartis, Ocera, Otsuka, PDL, Pharmacosmos, Pfizer, Procter & Gamble, Prometheus, Robarts Clinical Trial, Schering-Plough, Setpointmedical, Shire, Takeda, Therakos, Tigenix, UCB Pharma, Vifor, Yakult Austria, and 4SC. R. Strauss, C. Marano, J. Johanns, L. Padgett are employees of Janssen Research & Development, LLC. and may own Johnson & Johnson stock and/or options.

Figures

Figure 1
Figure 1
Study flow diagram.
Figure 2
Figure 2
Patients with Physician's Global Assessment (PGA) 0 or PGA 0/1 through week 104: golimumab induction responders who received golimumab on entry into the long-term extension for (a) intent-to-treat analysisa,b or (b) observed data analysis. (a) Patients who had a missing PGA score at a time point were considered as not having a PGA score of 0 (no disease activity) or 1 (mild disease activity). (b) Patients who initiated oral or parenteral corticosteroids (including budesonide), had an ostomy or colectomy, or who discontinued study agent due to lack of therapeutic effect before the week 104 visit were considered as not having a PGA score of 0/1 after the event.
Figure 3
Figure 3
Patients randomized to golimumab in the maintenance study who continued receiving golimumab in the long-term extension with PGA score of 0/1 at week 54 and maintained responsea: All golimumab induction responders who received golimumab (a), golimumab 50 mg (b), or golimumab 100 mg (c) on entry into the maintenance study. (a) Patients who entered the long-term extension and had a Physician's Global Assessment (PGA) subscore of 0/1 were evaluated for durability of response through week 104. Patients who met one of the treatment failure rules or who had a PGA score increase of ≥2 were considered to have lost response. Patients who discontinued before week 104 for reasons other than lack of efficacy were censored at their last follow-up visit. CI, confidence interval; PGA, Physician's Global Assessment.
Figure 4
Figure 4
Patients not receiving corticosteroids during the long-term extension study; intention-to-treat analysisa. (a) These patients were not receiving corticosteroids at week 54. Patients with a missing corticosteroid value had their last value carried forward and patients who met one of the treatment failure rules were considered to be receiving concomitant corticosteroids.
See this image and copyright information in PMC

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