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Table 5 Serum PF-06438179/GP1111/GP1111 and infliximab-EU concentrations by study visit and antidrug antibody status (pharmacokinetics population)

From: A randomized controlled trial comparing PF-06438179/GP1111 (an infliximab biosimilar) and infliximab reference product for treatment of moderate to severe active rheumatoid arthritis despite methotrexate therapy

 

All patients

ADA-positive patients

ADA-negative patients

 

PF-06438179/GP1111

Infliximab-EU

PF-06438179/GP1111

Infliximab-EU

PF-06438179/GP1111

Infliximab-EU

Ctrough, median (5th–95th percentile), ng/ml

 Week 0 (day 1)

n = 322

0 (0–0)

n = 323

0 (0–0)

n = 156

0 (0–0)

n = 166

0 (0–0)

n = 163

0 (0–0)

n = 156

0 (0–0)

 Week 2

n = 316

16,830 (6241–28,660)

n = 323

16,070 (6241–27,270)

n = 155

15,540 (5675–26,780)

n = 166

14,230 (5243–26,130)

n = 161

18,230 (6316–28,830)

n = 157

18,020 (9075–29,630)

 Week 4

n = 308

23,540 (4300–45,750)

n = 314

21,250 (2258–40,120)

n = 151

17,760 (765–37,420)

n = 164

16,370 (256–32,450)

n = 157

27,850 (10,660–49,180)

n = 150

26,880 (12,980–41,390)

 Week 6

n = 308

10,020 (102–26,650)

n = 315

9266 (0–24,180)

n = 151

6159 (0–20,180)

n = 163

5122 (0–17,440)

n = 157

14,030 (3960–29,890)

n = 152

12,790 (4321–26,420)

 Week 14

n = 302

1497 (0–10,590)

n = 310

1025 (0–7643)

n = 154

0 (0–4014)

n = 159

0 (0–3428)

n = 148

3351 (492–15,660)

n = 151

3063 (197–8440)

 Week 22

n = 295

576 (0–7911)

n = 303

433 (0–6221)

n = 152

0 (0–2262)

n = 156

0 (0–1151)

n = 143

2977 (206–10,640)

n = 147

2489 (0–7577)

 Week 30

n = 281

413 (0–7253)

n = 290

279 (0–6017)

n = 143

0 (0–533)

n = 149

0 (0–575)

n = 138

2846 (386–10,050)

n = 141

2385 (192–7580)

Cmax, median (5th–95th percentile), ng/ml

 Week 0 (day 1)

n = 319

64,240 (31,570–102,000)

n = 322

62,200 (23,260–95,990)

n = 154

63,830 (35,630–101,500)

n = 166

59,290 (1603–93,170)

n = 162

65,530 (11,180–102,000)

n = 155

66,080 (29,140–101,200)

 Week 14

n = 297

71,250 (1617–150,500)

n = 299

68,450 (3367–144,500)

n = 149

68,280 (0–157,500)

n = 152

62,010 (1091–118,200)

n = 148

75,640 (5633–129,400)

n = 147

75,090 (8857–159,800)

  1. Abbreviations: ADA Antidrug antibody, Cmax Observed serum drug concentration prior to the end of infusion, Ctrough Observed predose trough serum concentration, Infliximab-EU Infliximab sourced from the European Union