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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