Table 2. Summary of biologics agents investigated and/or approved in PsA.
| Agent | Agent description | Study | Dose | Study
size |
Demographics | ACR20 | PASI75 |
|---|---|---|---|---|---|---|---|
| Certolizumab | Pegylated humanized
anti-TNFα antigen binding fragment (Fab’) Binds soluble and membrane-bound TNFα |
RAPID-PsA 59 | Loading dose: 400 mg
at week 0, 2, and 4, then either 200 mg SC every 2 weeks or 400 mg SC every 4 weeks VS P |
409 |
Mean age
200 mg: 48.2 400 mg: 47.1 P: 47.3 Female (%) 200 mg: 53.6 400 mg: 54.1 P: 58.1 Mean duration PsA (years) 50 mg: 7.2 100 mg: 7.7 P: 7.6 Prior use 1 DMARD (%) 200 mg: 44.2 400 mg: 53.3 P: 54.4 2 DMARDs 200 mg: 52.9 400 mg: 44.5 P: 44.1 Prior TNF exposure (%) 200 mg: 22.5 400 mg: 17.0 P: 19.1 |
Week 12
200 mg: 58% 400 mg: 51.9% P: 24.3% Week 24 200 mg: 63.8% 400 mg: 56.3% P: 23.5% |
Week 12
200 mg: 46.7% 400 mg: 47.4% P: 14% Week 24 200 mg: 62.2% 400 mg: 60.5% P: 15.1% |
| Adalimumab | Human monoclonal Ab.
Binds soluble and membrane-bound TNFα |
ADEPT 60 | A 40 mg SC every 2 weeks
VS P |
315 |
Mean age
A: 48.6 P: 49.2 Male (%) A: 56 P: 55 Mean duration PsA (years) A: 9.8 P: 9.2 |
Week 12
A: 58% P: 14% |
Week 12
A: 49% Week 24 A: 59% P: 1% |
| Ixekizumab | IL17 inhibitor | SPIRIT-P1 66 | TNF-naïve patients
80 mg SC every 2 weeks 80 mg SC every 4 weeks following a loading dose of 160 mg, A 40 mg EOW, or P |
417 |
Mean age
Every 4 weeks: 49.2 Every 2 weeks: 49.8 P: 50.6 A 40 mg every 2 weeks: 48.6 Male (%) Every 4 weeks: 42.1 Every 2 weeks: 46.6 P: 45.3 A 40 every 2 weeks: 50.5 Mean duration PsA (years) Every 4 weeks: 13.8 Every 2 weeks: 14 P: 13.8 A 40 mg every 2 weeks: 12.7 |
24 weeks
80 mg every 2 weeks: 62.1% 80 mg every 4 weeks: 57.4% A: 57.9% P: 30.2% |
24 weeks
Every 4 weeks: 71.2% Every 2 weeks: 79.7% P: 10.4% A 40 mg every 2 weeks: 54.4% |
| Apremilast | Phosphodiesterase-4 inhibitor | PALACE 3 72 | 20 mg twice daily
30 mg twice daily VS P |
505 |
Female (%)
20 mg: 53 30 mg: 53 P: 54 Mean age 20 mg: 49.5 30 mg: 49.9 P: 49.5 Mean duration PsA (years) 20 mg twice daily: 7.7 30 mg twice daily: 7.5 P: 6.8 |
Week 16
20 mg twice daily: 28% 30 mg twice daily: 42% P: 18% Week 52 20 mg twice daily: 56% 30 mg twice daily: 63% |
Week 16
20 mg twice daily: 20% 30 mg twice daily: 21% P: 8% Week 52 20 mg twice daily: 29% 30 mg twice daily: 39% |
| Abatacept | CTLA4Ig inhibitor | ASTRAEA trial 73 | ABA SC 125 mg /week
VS P |
424
60% prior TNFi |
Mean age
ABA: 51 P: 49.8 Female (%) ABA: 56.8 P: 53.1 Mean duration PsA (years) ABA: 8.3 P: 8.8 |
24 weeks
ABA: 39.4% P: 22.3% |
24 weeks
ABA: 16.4% P: 10.1% |
| Tofacitinib | Inhibitor JAK3-1 | OPAL BROADEN 74 | Tofacitinib at a 5 mg dose by mouth twice daily
Tofacitinib 10 mg dose by mouth twice daily A at a 40 mg dose SC once every 2 weeks P with a blinded switch to 5 mg tofacitinib dose at 3 months or P with a blinded switch to the 10 mg tofacitinib dose at 3 months |
394 |
Mean age
5 mg: 49.4 10 mg: 46.9 P: 47.7 A: 47.4 Female (%) 5 mg: 53 10 mg: 60 P: 53 A: 47 Mean duration PsA (years) 5 mg: 7.3 10 mg: 5.4 P: 6.4 A: 5.3 |
12 weeks
5 mg: 50% 10 mg: 61% P: 33% A: 52% |
12 weeks
5 mg: 43% 10 mg: 44% P: 15% A: 39% |
| Adalimumab | GENOVESE 2007 85 | A 40 mg EOW
VS P Followed by open label study: A 40 mg EOW |
100 |
Mean age
A: 50.a P: 47.7 Male (%) A: 57 P: 51 Mean duration PsA (years) A: 7.5 P: 7.2 |
Week 12
A: 39% P: 16% |
||
| Etanercept | Fusion protein. Extracellular binding portion of TNF receptor (p75) dimerized on human IgG1 | Mease 2000 86 | E 25 mg SC twice week
VS P |
60 |
Mean age
E: 46 P: 43.5 Male (%) E: 53 P: 60 Mean duration PsA (years) E: 9.0 P: 9.5 |
12 weeks
E: 73% P: 13% |
12 weeks
E: 26% P: 0% |
| Mease 2004 87 | E 25 mg SC twice weekly × 24 weeks
VS P |
205 |
Mean age
E: 47.8 P: 47.3 Male (%) E: 57 P: 45 Mean duration PsA (years) E: 9.0 P: 9.2 |
E: 59%
P: 15% Sustained at 24 weeks |
E: 23%
P: 3% |
||
| Extension study
48 weeks 88 |
E: 64%
P: 50% |
||||||
| Infliximab | Mouse-human chimeric anti TNF monoclonal Ab.
Binds soluble and membrane-bound TNFα |
IMPACT 89 | I 5 mg/kg IV at weeks 0, 2, 6, and 14
VS P |
104 |
Mean age
I: 45.7 P: 45.2 Male (%) I: 58 P: 58 Mean duration PsA ( years) I: 16.9 P: 19.4 |
Week 16
I: 67,3% P: 11.5 % |
Week 16
I: 68% P: 0% |
| IMPACT 2 56 | I IV 5 mg/kg at weeks 0, 2, 6, 14, and 22
VS P |
200 |
Mean age
I: 47.1 P: 46.5 Male (%) I: 71 P: 51 Mean duration PsA (years) I: 8.4 P: 7.5 |
Week 12
I: 58% P: 11% |
I: 64%
P: 2% |
||
| Golimumab | Human monoclonal Ab.
Binds soluble and membrane-bound TNFα |
GO-REVEAL 90, | 50 mg or 100 mg SC
|
405 |
Mean age
50 mg: 45.7 100 mg: 48.2 P: 47.0 Male (%) 50 mg: 89 100 mg: 86 P: 69 Mean duration PsA (years) 50 mg: 7.2 100 mg: 7.7 P: 7.6 |
Week 14
50 mg: 51% 100 mg: 45% P: 9% |
Week 14
50 mg: 40% 100 mg: 58% P: 2.5% |
| Ustekinumab | Human mAb IgG1.
Binds to p40 of IL-12 and IL-23 |
PSUMMIT 1 91 | Previous inadequate response to MTX
45 mg 90 mg P Week 0, 4, and every 12 weeks |
615 |
Mean age
45 mg: 48 90 mg: 47 P: 48 Male (%) 45 mg: 51.7 90 mg: 56.9 P: 52.4 Mean duration PsA (years) 45 mg: 3.4 90 mg: 4.9 P: 3.6 |
Week 24
45 mg: 42.2% 90 mg: 49.5% P: 22.8% |
Week 24
45 mg: 57.2% 90 mg: 62.4% P: 11% |
| PSUMMIT 2 92 | 45 mg
90 mg P Week 0, 4, and every 12 weeks VS P with cross over to UST 45 mg at week 24, 28, and 40 |
312 |
Female (%)
45 mg: 53.4 90 mg: 53.3 P: 51 Mean age 45 mg: 49 90 mg: 48 P: 48 Mean duration PsA (years) 45 mg: 5.3 90 mg: 4.5 P: 5.5 |
45 mg: 43.7%
90 mg: 43.8% P: 20.2% Anti-TNF exposure 45 mg: 36.7% 90 mg: 34.5% P: 14.5% |
45 mg: 51.3%
90 mg: 55.6% P: 5% Anti-TNF exposure 45 mg: 45.5 % 90 mg: 48.8% P: 2.0% |
||
| Apremilast | PALACE 4
93
DMARD-naive |
20 mg/twice daily
30 mg/twice daily VS P At week 16 or 24, P patients were rerandomized to apremilast |
527 |
Mean age
20 mg: 49.2 30 mg: 48.4 P: 50.5 Female (%) 20 mg: 54.3 30 mg: 54.5 P: 48.9 Mean duration PsA (years) 20 mg: 15.3 30 mg: 15.4 P: 16.8 |
Week 16
20 mg: 28% 30 mg: 30.7% P: 15.9 % Week 52 20 mg: 53.4% 30 mg: 58.7% |
Week 16
20 mg: 17.3% 30 mg: 25.7% P: 10.8% Week 52 20 mg: 41% 30 mg: 31.9% |
|
| Secukinumab | IL-17 inhibitor | FUTURE 2 - 94 | Sec SC
300 mg 150 mg 75 mg VS P Week 1, 2, 34, and every 4 weeks after |
397 | Sec75: 50.3%
Sec150: 64.4% Sec300: 69.4% |
Sec75: 58.4%
Sec150: 73.3% Sec300: 79.5% |
|
| FUTURE 5 65 | Sec 300 mg
or 150 mg with loading dose, 150 mg without loading dose, or P. All groups received Sec or P at baseline, weeks 1, 2, and 3 and then every 4 weeks from week 4 |
996 |
Mean age
300 mg + loading dose: 48.9 150 mg + loading dose: 48.4 150 mg: 48.8 P: 49 Female (%) 300 mg + loading dose: 51.4 150 mg + loading dose: 49.5 150 mg: 4.5.9 P: 51.5 Mean duration PsA (years) 300 mg + loading dose: 48.9 150 mg + loading dose: 48.4 150 mg: 48.8 P: 49 |
Week 16
300 mg with loading dose: 62.6% 150 mg with loading dose: 55.5% 150 mg without loading dose: 59.5% P: 27.4% |
Week 16
300 mg + loading dose: 70% 150 mg + loading dose: 60 150 mg: 58.1 P: 12.3 |
ABA, Abatacept; A, adalimumab; E, etanercept; EOW, every other week; I, infliximab; IV, intravenous; mAb, monoclonal antibody; mg, milligrams; P, placebo; PsA, psoriatic arthritis; SC, subcutaneous; Sec, secukinumab; TNFi, tumour necrosis factor inhibitor; VS, versus