P1635 - Health-Related Quality of Life With Ustekinumab vs Adalimumab for Induction and Maintenance Therapy in Biologic-Naïve Patients With Moderate-To-Severe Crohn’s Disease: PROMIS-29 in the SEAVUE Study

Monday, October 25, 2021

10:30 AM – 4:15 PM PT

Location: Shoreline Exhibit Hall

Has Audio

Presenting Author(s)

JI

James Izanec, MD

James D. Lewis, MD, MSCE¹, Matthieu Allez, MD², Peter M. Irving, MD, MA, FRCP³, Timothy Hoops, MD⁴, James L. Izanec, MD⁴, Tony Ma, ⁵, Zhijie Ding, PhD, MS⁴, Erik Muser, PharmD, MPH⁴, Christopher Gasink, MD⁴, Remo Panaccione, MD, FRCP⁶, Edward V. Loftus, MD, FACG⁷, Silvio Danese, MD, PhD⁸, Bruce E. Sands, MD, MS⁹
¹University of Pennsylvania Perelman School of Medicine, Philadelphia, PA; ²Universite de Paris, Hopital Saint-Louis Hospital, Assistance Publique-Hopitaux de Paris (AP-HP), Paris, Ile-de-France, France; ³Guy's and St. Thomas' Hospitals NHS Trust, London, UK; King's College Long, London, England, United Kingdom; ⁴Janssen Scientific Affairs, LLC, Horsham, PA; ⁵Janssen R&D, LLC, Spring House, PA; ⁶Inflammatory Bowel Disease Clinic, Gastrointestinal Research, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada; ⁷Mayo Clinic, Rochester, MN; ⁸Inflammatory Bowel Diseases Center, Humanitas Clinical and Research Center IRCCS and Hunimed, Milan, Lombardia, Italy; ⁹Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY

Introduction: Patients (pts) with Crohn’s disease (CD) suffer from systemic symptoms, including fatigue, that negatively affect health-related quality of life (HRQoL). In SEAVUE, we evaluated the changes in systemic symptoms through 1 year with ustekinumab (UST) vs adalimumab (ADA) in biologic-naïve pts with CD using the Patient-Reported Outcome Measurement Information System-29 (PROMIS-29) questionnaire. PROMIS-29 measures anxiety, depression, fatigue, sleep disturbance, pain interference, pain intensity, physical function, and ability to participate in social roles and activities.

Methods: SEAVUE was a multicenter, randomized, blinded, parallel-group, active-controlled study in biologic-naïve adults with CD Activity Index (CDAI) scores ≥220/≤450. Pts were randomized 1:1 to UST (⁓6mg/kg IV at baseline then 90mg SC every 8 weeks) or ADA (160/80mg SC at baseline/Week 2, then 40mg SC every 2 weeks) per US-approved regimens. Dose modification was not allowed. Mean changes and clinically meaningful improvement from baseline were assessed for each PROMIS-29 domain.

Results: Among 386 randomized pts, baseline mean PROMIS-29 scores were similar between treatment groups (anxiety: 60 UST, 60 ADA; depression: 57 UST, 57 ADA; fatigue: 62 UST, 61 ADA; sleep disturbance: 54 UST, 53 ADA; pain interference: 61 UST, 60 ADA; pain intensity: 6 UST, 5 ADA; physical function: 43 UST, 44 ADA; ability to participate in social roles and activities: 44 UST, 45 ADA). In both groups, improvements in all PROMIS-29 domain scores were observed as early as Week 8 (data not shown) and continued through Week 52 (Table). Improvements from baseline to Week 52 were similar between groups for all domains. When clinically meaningful improvement from baseline to Week 52 (change ≥5 points) was evaluated, significantly more pts in the UST vs ADA group achieved this endpoint for the fatigue (decrease ≥5 points: 58.6% UST, 47.7% ADA; nominal p=0.030) and ability to participate in social roles and activities (increase ≥5 points: 58.6% UST, 47.7% ADA; nominal p=0.032) domains; there was no significant difference between groups for the other domains.

Discussion: PROMIS-29 domain scores improved similarly with UST and ADA through Week 52 in biologic-naïve pts with moderate-to-severe CD. Clinically meaningful improvement in fatigue and ability to participate in social roles and activities scores was more commonly observed with UST vs ADA, potentially reflecting better HRQoL in biologic-naïve pts with CD.

Outcome^a,b	n	Adalimumab (N=195)	n	Ustekinumab (N=191)
Mean (SD) change from baseline at Week 52
Anxiety T-score	190	-6.0 (9.2)	190	-6.6 (10.0)
Depression T-score	191	-5.0 (7.9)	190	-5.4 (9.0)
Fatigue T-score	190	-7.8 (10.3)	189	-9.9 (10.9)
Sleep disturbance T-score	191	-1.9 (4.9)	187	-2.1 (4.9)
Pain interference T-score	191	-9.7 (9.3)	190	-9.3 (10.2)
Pain intensity score	192	-2.8 (2.6)	189	-2.7 (2.8)
Physical function T-score	191	5.1 (7.8)	190	5.9 (8.6)
Ability to participate in social roles and activities T-score	191	7.4 (9.2)	190	8.7 (10.2)
Achievement of clinically meaningful change at Week 52
Anxiety T-score, ≥5-point decrease from baseline, n (%)		77 (39.5)		88 (46.1)
Depression T-score, ≥5-point decrease from baseline, n (%)		70 (35.9)		78 (40.8)
Fatigue T-score, ≥5-point decrease from baseline, n (%)		93 (47.7)		112 (58.6)^∗
Sleep disturbance T-score, ≥5-point decrease from baseline, n (%)		42 (21.5)		43 (22.5)
Pain interference T-score, ≥5-point decrease from baseline, n (%)		106 (54.4)		101 (52.9)
Pain intensity score, decrease ≥one-half baseline SD, n (%)		113 (57.9)		110 (57.6)
Physical function T-score, ≥5-point increase from baseline, n (%)		74 (37.9)		81 (42.4)
Ability to participate in social roles and activities T-score, ≥5-point increase from baseline, n (%)		93 (47.7)		112 (58.6)^∗
a Pts who had a prohibited CD-related surgery, had prohibited concomitant medication changes, or discontinued study agent due to lack of efficacy or due to an adverse event indicated to be of worsening CD prior to the designated analysis timepoint had their baseline value carried forward for continuous endpoints or were considered not to have achieved the endpoint for binary endpoints. b Pts who had insufficient data at the designated analysis timepoint had their last value carried forward for continuous endpoints or were considered not to have achieved the endpoint for binary endpoints. *Nominal p< 0.05; SD = standard deviation

Table: Table. Change from baseline to Week 52 in PROMIS-29 domain scores and the percentage of pts who achieved a clinically meaningful improvement between baseline and Week 52

Disclosures:

James Lewis: Arena – Consultant. Bridge Biotherapeutics – Consultant. Bristol Myers Squibb – Consultant. Celgene – Consultant. Entasis Therapeutics – Consultant. Gilead – Consultant. Janssen – Consultant, Grant/Research Support. Merck – Consultant. Nestle Health Science – Grant/Research Support. Pfizer – Consultant. Protagonist Therapeutics – Consultant. Takeda – Grant/Research Support.

Matthieu Allez: Biogen – Other Financial or Material Support, Lecture fees. Boehringer Ingelheim – Advisory Committee/Board Member. Bristol Myers Squibb – Advisory Committee/Board Member. Celltrion Healthcare – Advisory Committee/Board Member. Ferring – Other Financial or Material Support, Lecture fees. Genentech – Advisory Committee/Board Member. Janssen – Advisory Committee/Board Member, Other Financial or Material Support, Lecture fees. Novartis – Advisory Committee/Board Member. Pfizer – Advisory Committee/Board Member, Other Financial or Material Support, Lecture fees. Roche – Advisory Committee/Board Member. Takeda – Other Financial or Material Support, Lecture fees. Tillots – Other Financial or Material Support, Lecture fees.

Peter Irving: AbbVie – Advisory Committee/Board Member, Other Financial or Material Support, Lecture fees. Arena – Advisory Committee/Board Member. Celgene – Other Financial or Material Support, Lecture fees. Falk Pharma – Other Financial or Material Support, Lecture fees. Ferring – Other Financial or Material Support, Lecture fees. Genentech – Advisory Committee/Board Member. Gilead – Advisory Committee/Board Member. Hospira – Advisory Committee/Board Member. Janssen – Advisory Committee/Board Member, Other Financial or Material Support, Lecture fees. Lilly – Advisory Committee/Board Member. MSD – Advisory Committee/Board Member, Grant/Research Support, Other Financial or Material Support, Lecture fees. Pfizer – Advisory Committee/Board Member, Grant/Research Support, Other Financial or Material Support, Lecture fees. Pharmacosmos – Advisory Committee/Board Member. Prometheus – Advisory Committee/Board Member. Roche – Advisory Committee/Board Member. Samsung Bioepis – Advisory Committee/Board Member. Sandoz – Advisory Committee/Board Member, Other Financial or Material Support, Lecture fees. Sapphire Medical – Other Financial or Material Support, Lecture fees. Shire – Other Financial or Material Support, Lecture fees. Takeda – Advisory Committee/Board Member, Grant/Research Support, Other Financial or Material Support, Lecture fees. Tillots – Other Financial or Material Support, Lecture fees. Topivert – Advisory Committee/Board Member. VH2 – Advisory Committee/Board Member. Vifor Pharma – Advisory Committee/Board Member. Warner Chilcott – Advisory Committee/Board Member, Other Financial or Material Support, Lecture fees.

Timothy Hoops: Janssen Scientific Affairs – Employee, Stockholder/Ownership Interest (excluding diversified mutual funds).

James Izanec: Janssen Scientific Affairs – Employee, Stockholder/Ownership Interest (excluding diversified mutual funds).

Tony Ma: Janssen Scientific Affairs – Employee, Stockholder/Ownership Interest (excluding diversified mutual funds).

Zhijie Ding: Janssen Scientific Affairs – Employee, Stockholder/Ownership Interest (excluding diversified mutual funds).

Erik Muser: Janssen Scientific Affairs – Employee, Stockholder/Ownership Interest (excluding diversified mutual funds).

Christopher Gasink: Janssen Scientific Affairs – Employee, Stockholder/Ownership Interest (excluding diversified mutual funds).

Remo Panaccione: AbbVie – Consultant. Janssen – Consultant. Takeda California – Consultant.

Edward Loftus: AbbVie – Consultant, Grant/Research Support. Allergan – Consultant. Amgen – Consultant, Grant/Research Support. Arena – Consultant. Boehringer Ingelheim – Consultant. Bristol Myers Squibb – Consultant, Grant/Research Support. Calibr – Consultant. Celgene – Consultant, Grant/Research Support. Celltrion Healthcare – Consultant. Genentech – Consultant, Grant/Research Support. Gilead – Consultant, Grant/Research Support. Iterative Scopes – Consultant. Janssen – Consultant, Grant/Research Support. Lilly – Consultant. Ono Pharma – Consultant. Pfizer – Consultant, Grant/Research Support. Receptos – Grant/Research Support. Robarts Clinical Trial – Grant/Research Support. Sun Pharma – Consultant. Takeda – Consultant, Grant/Research Support. Theravance – Grant/Research Support. UCB – Consultant, Grant/Research Support.

Silvio Danese: Allergan – Consultant. Amgen – Consultant. AstraZeneca – Consultant. Biogen – Consultant. Boehringer Ingelheim – Consultant. Celgene – Consultant. Celltrion Healthcare – Consultant. Ferring – Consultant. Gilead – Consultant. Hospira – Consultant. Janssen – Consultant. Johnson & Johnson Healthcare Systems – Consultant. Pfizer – Consultant. Sandoz – Consultant. UCB – Consultant. Vifor International – Consultant.

Bruce Sands: 4D Pharma – Consultant. AbbVie – Consultant. Abivax – Consultant. Allergan – Consultant. Amgen – Consultant. Arena – Consultant, Grant/Research Support. AstraZeneca – Consultant. Baxalta Bioscience India – Consultant. Boehringer Ingelheim – Consultant. Boston Pharmaceuticals – Consultant. Capella Bioscience – Consultant. Celgene – Consultant, Grant/Research Support. Celltrion Healthcare – Consultant. Ferring – Consultant. Genentech – Consultant. Gilead – Consultant. GlaxoSmithKline – Consultant. Hoffmann-La Roche – Consultant. Immunic – Consultant. InDex Pharmaceuticals – Consultant. Inotrem – Consultant. Ironwood Pharmaceuticals – Consultant. Janssen – Consultant. Johnson & Johnson – Consultant. Kallyope – Consultant. Lilly – Consultant. Morphic Therapeutic – Consultant. Oppilan Pharma – Consultant. OSE Immunotherapeutics – Consultant. Otsuka – Consultant. Palatin Technologies – Consultant. Pfizer – Consultant. Progenity – Consultant. Prometheus Biosciences IBD – Consultant. Prometheus Laboratories – Consultant. Protagonist Therapeutics – Consultant. Redhill Biopharma – Consultant. Rheos Medicines – Consultant. Salix Pharmaceuticals – Consultant. Seres Therapeutics – Consultant. Shire – Consultant. Sienna Biopharmaceuticals – Consultant. Surrozen – Consultant. Takeda – Consultant. TARGET RWE – Consultant. Theravance Biopharma Research & Development – Consultant, Grant/Research Support. USWM Enterprises – Consultant. Viela Bio – Consultant. Vivelix Pharmaceuticals – Consultant.