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Table 2 Proportion of patients with SR and its components at week 52 and week 24

From: A phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis

n (%)

SAR200 + 26W taper

SAR150 + 26W taper

PBO + 52W taper

PBO + 26W taper

Primary endpoint and sensitivity analyses, n

13

7

10

6

 Number of patients achieving SR at week 52

6 (46)

3 (43)

3 (30)

0

 Number of patients achieving SR at week 52 excluding CRP

6 (46)

3 (43)

6 (60)

1 (17)

 Number of patients achieving SR at week 52 excluding CRP and ESR

6 (46)

3 (43)

6 (60)

1 (17)

Additional endpoint and sensitivity analyses, n

27

14

28

14

 Number of patients achieving SR at week 24

13 (48)

6 (43)

11 (39)

1 (7)

 Number of patients achieving SR at week 24 excluding CRP

13 (48)

6 (43)

16 (57)

5 (36)

 Number of patients achieving SR at week 24 excluding CRP and ESR

13 (48)

6 (43)

16 (57)

5 (36)

Secondary endpoints

 Week 52, n

13

7

10

6

  Achievement of disease remission no later than week 12a

7 (54)

4 (57)

7 (70)

3 (50)

  Absence of disease flare from week 12 through week 52b

7 (54)

4 (57)

7 (70)

3 (50)

  Sustained reduction of CRP from week 12 through week 52c

8 (62)

5 (71)

6 (60)

3 (50)

  Successful adherence to the prednisone taper from week 12 through week 52d

6 (46)

3 (43)

6 (60)

2 (33)

 Week 24, n

27

14

28

14

  Achievement of disease remission no later than week 12a

15 (56)

9 (64)

16 (57)

6 (43)

  Absence of disease flare from week 12 through week 24b

15 (56)

10 (71)

21 (75)

7 (50)

  Sustained reduction of CRP from week 12 through week 24c

17 (63)

11 (79)

20 (71)

4 (29)

  Successful adherence to the prednisone taper from week 12 through week 24d

13 (48)

7 (50)

18 (64)

5 (36)

  1. Week 52 analysis set included patients who had an opportunity to complete the 52-week treatment period and had a randomization date prior to 16 Oct 2019. Patients who did not achieve remission, received rescue treatment with open-label prednisone (or equivalent), withdrew from the study before week 52, or had missing data that prevented assessment of the primary endpoint were considered as non-responders. Week 24 was the ITT population
  2. AE Adverse event, APR Acute-phase reactant, CRP C-reactive protein, ESR Erythrocyte sedimentation rate, GC Glucocorticoid, GCA Giant cell arteritis, ITT Intent-to-treat, n number of patients, PBO Placebo, SAR150/200 Sarilumab 150/200 mg, SR Sustained remission, W Week
  3. aDisease remission is defined as resolution of signs and symptoms of GCA, and normalization of CRP (< 10 mg/L)
  4. bFlare is defined as either recurrence of signs and symptoms attributable to active GCA plus an increase in GC dose due to GCA or elevation of ESR attributable to active GCA plus an increase in GC dose due to GCA
  5. cThe status of normalization of CRP from week 12 through week 52 was determined based on the CRP values measured at weeks 16, 20, 24, 32, 40, and 52, or at weeks 16, 20, and 24 for week 12 through week 24. If there were ≥ 2 consecutive visits with CRP ≥ 10 mg/L, then it was categorized as no normalization of CRP
  6. dSuccessful adherence to the prednisone taper from week 12 through week 24/52 is defined as patients did not take rescue therapy from week 12 through week 24/52 and may include the use of any excess prednisone (beyond the per-protocol GC-taper regimen) with a cumulative dose of ≤ 100 mg (or equivalent), such as those employed to manage AE not related to GCA. The cumulative dose of excess prednisone use was counted from baseline to week 24/52
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Arthritis Research & Therapy

ISSN: 1478-6362

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