ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 2547

Upadacitinib Monotherapy Improves Patient-Reported Outcomes in Patients with Rheumatoid Arthritis and Inadequate Response to Methotrexate

Vibeke Strand1, Maya Buch2, Namita Tundia3, Heidi S. Camp3, Jessica Suboticki3, Debbie Goldschmidt4 and Alvin F. Wells5, 1Stanford University, Palo Alto, CA, 2NIHR Leeds Musculoskeletal Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom, 3AbbVie Inc., North Chicago, IL, 4Analysis Group Inc., New York, NY, 5Rheumatology and Immunotherapy Center, Franklin, WI

Meeting: 2018 ACR/ARHP Annual Meeting

Keywords: ,

Session Information

Date: Tuesday, October 23, 2018

Title: Rheumatoid Arthritis – Treatments Poster III: Biosimilars and New Compounds

Session Type: ACR Poster Session C

Session Time: 9:00AM-11:00AM

Background/Purpose: Upadacitinib (UPA) is a selective JAK-1 inhibitor with demonstrated patient-reported benefits in the treatment of active rheumatoid arthritis (RA).1,2 The objective of this analysis was to evaluate the effect of UPA compared to MTX on PROs in the SELECT-MONOTHERAPY randomized controlled trial (RCT).

Methods: SELECT-MONOTHERAPY (NCT02706951) is a Phase 3 RCT conducted in patients with active RA with inadequate responses to MTX (MTX-IR) that were switched to UPA monotherapy (15 mg or 30 mg once daily) or continued on MTX. The following PROs were included: Patient Global Assessment of Disease Activity (PtGA) by visual analog scale (VAS), pain by VAS, Health Assessment Questionnaire Disability Index (HAQ-DI), and health-related quality of life (HRQOL) by 36-Item Short Form Health Survey (SF-36). Least squares mean (LSM) changes from baseline to Week 14 were based on mixed effect repeated measures models. The percentage of patients reporting improvements ≥minimum clinically important differences (MCID) in PROs from baseline to Week 14 and scores ≥normative values were determined; comparisons between groups used chi-square tests, statistical significance at the 5% level.

Results: Data from 648 patients (215, 217, and 216 in the UPA 30 mg, UPA 15 mg, and MTX group [mean dose: 17mg/week], respectively) were analyzed. Mean age was 54.3 years, 80.7% were female, and 42.3% had RA for ≥5 years. At Week 14, both UPA doses resulted in statistically significant LSM changes from baseline vs MTX in PtGA, pain, HAQ-DI, SF-36 Physical (PCS) and Mental Component Summary (MCS), and all SF-36 domain scores (Table). Compared with MTX, statistically more patients reported improvements ≥MCID across all PROs in UPA 30 mg and all but SF-36 MCS and SF domain scores in UPA 15 mg (Table). Scores ≥normative values were reported across all PROs in UPA 30mg and all but SF-36 MCS and RP, GH, RE, and MH SF-36 domains in UPA 15 mg.

Conclusion: Treatment with UPA 15 mg or 30 mg as monotherapy for 14 weeks resulted in statistically significant and clinically meaningful improvements in PROs compared with MTX, including disease activity, pain, physical function, and HRQOL among MTX-IR patients.

References: 1. Strand et al. Poster SAT0254, European League Against Rheumatism (EULAR) 2018; 2. Strand et al. Poster SAT0255, European League Against Rheumatism (EULAR), 2018.

 

 

LSM Changes From Baseline and Percentage of Responders at Week 14 After UPA Initiation

PRO

Baseline
Mean

LSM Changes From Baseline

Patients Reporting Improvements
≥MCID, n (%)

 

(n=647)

MTX

(n=216)

UPA 15 mg

(n=217)

UPA 30 mg

(n=215)

MTX

(n=216)

UPA 15 mg

(n=217)

UPA 30 mg

(n=215)

PtGA

60.4

–11.18

–23.40*

–29.89*

102 (47.2)

132 (61.1)*

158 (73.5)*

Pain VAS

62.3

–13.88

–26.15*

–33.18*

100 (46.3)

139 (64.4)*

162 (75.3)*

HAQ-DI

1.5

–0.32

–0.65*

–0.73*

98 (45.4)

140 (64.8)*

148 (68.8)*

SF-36 PCS

33.5

4.32

8.28*

10.19*

103 (47.7)

141 (65.0)*

157 (73.4)*

SF-36 MCS

44.6

1.88

4.55*

4.68*

91 (42.1)

109 (50.2)

124 (57.9)*

SF-36 PF

32.9

4.11

8.47*

10.27*

124 (57.4)

161 (74.2)*

162 (75.3)*

SF-36 RP

35.3

3.58

7.02*

8.26*

101 (46.8)

150 (69.1)*

154 (71.6)*

SF-36 BP

35.2

4.67

8.89*

11.02*

114 (52.8)

148 (68.2)*

159 (74.0)*

SF-36 GH

38.6

2.81

5.57*

7.05*

115 (53.2)

146 (67.3)*

146 (67.9)*

SF-36 VT

41.6

3.13

8.06*

8.36*

107 (49.5)

152 (70.0)*

151 (70.2)*

SF-36 SF

39.9

3.56

6.26*

7.01*

103 (47.7)

121 (55.8)

129 (60.0)*

SF-36 RE

40.3

2.05

4.82*

6.08*

82 (38.0)

118 (54.4)*

123 (57.2)*

SF-36 MH

42.0

2.46

5.35*

5.67*

108 (50.0)

133 (61.3)*

132 (61.4)*

*P<0.05 for UPA vs MTX. LSM change from baseline P values represent statistical significance between groups.

BP, bodily pain; GH, general health; HAQ-DI, Health Assessment Questionnaire Disability Index; LSM, least squares mean; MCID, minimum clinically important difference; MCS, Mental Component Summary; MH, mental health; MTX, methotrexate; PCS, Physical Component Summary; PF, physical function; PRO, patient-reported outcome; PtGA, Patient’s Global Assessment of Disease Activity; RE, role emotional; RP, role physical; SF, social function; SF-36, 36-Item Short Form Health Survey; UPA, upadacitinib; VAS, visual analog scale; VT, vitality.

 

Medical writing services provided by Hannah Greenwood (Fishawack Communications) and funded by AbbVie.

Disclosure: V. Strand, AbbVie, Amgen, AstraZeneca, BMS, Boehringer Ingelheim, Celltrion, EMD Serono, Genentech/Roche, GSK, Janssen, Lilly, Novartis, Pfizer, Regeneron, Sanofi, and UCB, 5; M. Buch, Pfizer Ltd, Roche, and UCB, 2,Abbvie, BMS, Eli Lilly, Roche, Pfizer, and Sandoz, 5; N. Tundia, AbbVie Inc., 1, 3; H. S. Camp, AbbVie Inc., 1, 3; J. Suboticki, AbbVie Inc., 3,AbbVie Inc., 1; D. Goldschmidt, Analysis Group, which received research funding from AbbVie for this study, 3; A. F. Wells, AbbVie Inc., 2, 5,AbbVie Inc., 2.

To cite this abstract in AMA style:

Strand V, Buch M, Tundia N, Camp HS, Suboticki J, Goldschmidt D, Wells AF. Upadacitinib Monotherapy Improves Patient-Reported Outcomes in Patients with Rheumatoid Arthritis and Inadequate Response to Methotrexate [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/upadacitinib-monotherapy-improves-patient-reported-outcomes-in-patients-with-rheumatoid-arthritis-and-inadequate-response-to-methotrexate/. Accessed .

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