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Abstract Number: 1517

Integrated Safety Analysis across Phase 3 Clinical Studies Including the Controlled and Uncontrolled Periods for Intravenous Golimumab in Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis

Arthur Kavanaugh1, Atul A. Deodhar2, Sergio Schwartzman3, Shelly Kafka4, Soumya D Chakravarty5, Elizabeth C Hsia6, Diane D. Harrison7, Jocelyn Leu7, Yiying Zhou7, Kim Hung Lo7 and M. Elaine Husni8, 1University of California, San Diego, School of Medicine, La Jolla, CA, 2Oregon Health & Science U, Portland, OR, 3Weill Cornell Medical College, New York, NY, 4Janssen Scientific Affairs, LLC, Horsham, PA, 5Janssen Scientific Affairs, LLC/Drexel University School of Medicine, Horsham/Phila, PA, 6Janssen Reseach & Development, LLC/ U of Pennsylvania School of Medicine, Spring House/Philadelphia, PA, 7Janssen Research & Development, LLC, Spring House, PA, 8Orthopedic and Rheumatologic Institute, Cleveland Clinic, Cleveland, OH

Meeting: 2018 ACR/ARHP Annual Meeting

Keywords: Ankylosing spondylitis (AS), Psoriatic arthritis, rheumatoid arthritis (RA) and safety

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Session Information

Date: Monday, October 22, 2018

Session Title: Rheumatoid Arthritis – Treatments Poster II: PROs, Safety and Comorbidity

Session Type: ACR Poster Session B

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

Background/Purpose: The GO-FURTHER, GO-VIBRANT, and GO-ALIVE randomized controlled trials evaluated the efficacy and safety of intravenous (IV) golimumab (GLM) in patients (pts) with active rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS), respectively. This integrated analysis assessed safety events across indications in pts who received IV GLM.

Methods: Integrated safety data from 3 Phase 3, double-blind, placebo (PBO)-controlled trials were analyzed up to week (WK) 112 in RA pts and up to WK 60 in PsA and AS pts. Pts received either IV PBO or IV GLM (2 mg/kg) at 0, 4, 12, and 20 WKS. PBO pts crossed over to IV GLM at WK 24, except RA pts randomized to PBO who met early escape criteria crossed over at WK 16 and AS pts randomized to PBO who crossed over at WK 16. Cumulative adverse events (AEs) were reported by indication and pooled by treatment. Anti-drug antibodies (ADAs) were evaluated.

Results: Overall, 1248 pts were treated with IV GLM across indications. A numerically greater proportion (%) of IV GLM pts with RA reported safety events than pts with PsA or AS (Table 1): SAEs (18.2 vs 5.2 vs 3.4), infections (49.1 vs 22.8 vs 32.8), serious infections (6.2 vs 2.2 vs 1.5), and infusion reactions (4.6 vs 0.9 vs 1.5). Incidence (per 100 pt-years) of opportunistic infections, malignancy, active tuberculosis, and death with IV GLM was low (≤0.5) across indications (Table 2). Infections were the most commonly reported type of SAE among pooled IV GLM pts; the most frequent was pneumonia (10 [0.8%]). Incidence (per 100 pt-years) of serious infections was similar among IV GLM pts with and without corticosteroid use (3.35 vs 3.37, respectively). Overall, 1 IV GLM pt (PsA) experienced a demyelination event. A numerically greater proportion of IV GLM pts discontinued due to an AE than PBO pts (5.0% vs 0.9%, respectively). In IV GLM pts with baseline alanine aminotransferase (ALT) ≤ upper limit of normal (ULN), 1.2% had post-baseline ALT elevations ≥5X ULN. The proportion of IV GLM and PBO pts with post-baseline ALT elevations ≥5X ULN was 2.1% vs 0% with methotrexate and 0.7% vs 1.4% without methotrexate use at baseline, respectively. Using a drug-tolerant enzyme immunoassay, the incidence of ADAs was 22% through WK 52 across indications, which primarily consisted of low titer ADAs.

Conclusion: IV GLM demonstrated a consistent safety profile across indications in the PBO-controlled (up to WK 24) and uncontrolled study periods. Similar to WK 24, more safety events occurred in RA pts, who represented the largest study population with older pts, longer disease duration, and more concomitant medication use.

 


 

Table 1. Summary of Adverse Events During the Placebo-controlled and Uncontrolled Study Periods

Variables

RAa

PsAb

ASb

All

IV GLM

IV GLM

IV GLM

IV GLM

Treated patients, n

584

460

204

1248

Average duration of follow up, wks

95.9

47.2

51.8

70.7

Patients who discontinued due to

  an AE

41 (7.0)

17 (3.7)

4 (2.0)

62 (5.0)

Patients with ≥1 AE

462 (79.1)

234 (50.9)

113 (55.4)

809 (64.8)

Patients with ≥1 SAE

106 (18.2)

24 (5.2)

7 (3.4)

137 (11.0)

Patients with ≥1 infection

287 (49.1)

105 (22.8)

67 (32.8)

459 (36.8)

Patients with ≥1 serious infection

36 (6.2)

10 (2.2)

3 (1.5)

49 (3.9)

Patients with ≥1 infusion reaction

27 (4.6)

4 (0.9)

3 (1.5)

34 (2.7)

ADA-positive patientsc, %

23.4

22.0

20.2

22.3

Patients n (%) reporting safety events during the placebo-controlled and uncontrolled study periods are reported, unless otherwise specified.

aBased on safety events that occurred up to week 112

bBased on safety events that occurred up to week 60

cAssessed using a drug-tolerant enzyme immunoassay based on IV GLM patients with appropriate samples through week 52 (RA, n=552; PsA,
n=450; AS, n=203; and All, n=1205)

ADA, anti-drug antibody; AE, adverse event; AS, ankylosing spondylitis; IV GLM, intravenous golimumab; PsA, psoriatic arthritis; RA,
rheumatoid arthritis; SAE, serious adverse event

 

Table 2. Incidence of Safety Events Per 100 Patient-Years

Variables

RAa

PsAb

ASb

All

IV GLM

Placebo

IV GLM

Placebo

IV GLM

Placebo

IV GLM

Placebo

Treated patients, n

584

197

460

239

204

103

1248

539

Average duration of follow up, wks

95.9

21.0

47.2

23.2

51.8

16.1

70.7

21.0

Opportunistic infections

0.4

0

0

0

0

0

0.2

0

  (95% confidence interval)

(0.1, 1.0)

(0, 3.8)

(0, 0.7)

(0, 2.8)

(0, 1.5)

(0, 9.4)

(0.1, 0.6)

(0, 1.4)

All malignancies

0.5

0

0.5

1.9

0

0

0.4

0.9

  (95% confidence interval)

(0.2, 1.1)

(0, 3.8)

(0.1, 1.7)

(0.2, 6.8)

(0, 1.5)

(0, 9.4)

(0.2, 0.9)

(0.1, 3.3)

Active TB

0.2

0

0.5

0

0.5

0

0.3

0

  (95% confidence interval)

(0, 0.7)

(0, 3.8)

(0.1, 1.7)

(0, 2.8)

(0, 2.7)

(0, 9.4)

(0.1, 0.7)

(0, 1.4)

Death

0.5

1.3

0.2

1.9

0

0

0.4

1.4

  (95% confidence interval)

(0.2, 1.1)

(0, 7.0)

(0, 1.3)

(0.2, 6.8)

(0, 1.5)

(0, 9.4)

(0.1, 0.8)

(0.3, 4.0)

Incidence per 100 patient-years are reported, unless otherwise specified.

aBased on safety events that occurred up to week 112

bBased on safety events that occurred up to week 60

AS, ankylosing spondylitis; IV GLM, intravenous golimumab; PsA, psoriatic arthritis, RA, rheumatoid arthritis; TB, tuberculosis

 


Disclosure: A. Kavanaugh, Janssen Research Development, LLC, 2; A. A. Deodhar, Janssen Research & Development, LLC, 2; S. Schwartzman, Janssen Research & Development, LLC, 2; S. Kafka, Janssen Scientific Affairs, LLC, 3; S. D. Chakravarty, Janssen Scientific Affairs, LLC, 3; E. C. Hsia, Janssen Research & Development, LLC, 3; D. D. Harrison, Janssen Research & Development, LLC, 3; J. Leu, Janssen Research Development, LLC, 3; Y. Zhou, Janssen Research Development, LLC, 3; K. H. Lo, Janssen Research & Development, LLC, 3; M. E. Husni, Janssen Research & Development, LLC, 2.

To cite this abstract in AMA style:

Kavanaugh A, Deodhar AA, Schwartzman S, Kafka S, Chakravarty SD, Hsia EC, Harrison DD, Leu J, Zhou Y, Lo KH, Husni ME. Integrated Safety Analysis across Phase 3 Clinical Studies Including the Controlled and Uncontrolled Periods for Intravenous Golimumab in Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/integrated-safety-analysis-across-phase-3-clinical-studies-including-the-controlled-and-uncontrolled-periods-for-intravenous-golimumab-in-rheumatoid-arthritis-psoriatic-arthritis-and-ankylosing-spon/. Accessed February 5, 2023.
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