Skip to main content
. 2023 Oct 31;16:3129–3145. doi: 10.2147/CCID.S433367

Table 1.

JAK Inhibitors in Psoriatic Disease

Drug; Trial Trial Description/Duration Patients Efficacy AEs; Discontinuation for AEs
Tofacitinib; NCT0067821065 Phase IIb, randomized placebo-controlled, dose-ranging study / 12 weeks 197 pts
Randomization to:

  • PBO: 50

  • Tofacitinib 2mg BID: 49

  • Tofacitinib 5mg BID: 49

  • Tofacitinib 15mg BID: 49

 At week 12, PASI75 response rates were significantly higher for all tofacitinib groups: 25.0% (2mg; p<0.001), 40.8% (5mg; p<00001) and 66.7% (15mg; p<0.0001), compared with placebo (2.0%) Therapy-arm group: 115 (58.4%); 9 (4.6%)
Placebo: 30 (60.0%); 3 (6.0%)
Most frequent AEs: upper respiratory tract infection, nasopharyngitis and headache.
Tofacitinib; OPT Pivotal 166 Phase II, randomized placebo-controlled / 16 weeks 900 pts
Randomization to:

  • PBO: 177

  • Tofacitinib 5mg BID: 360

  • Tofacitinib 10mg BID: 363

 At week 16, PGA response* rates in tofacitinib 5mg group and 10mg group were 152 (41.9%) and 213 (59.2%), respectively, significantly higher than placebo: 16 (9.0%) (<0.001 vs placebo in both groups)
PASI75 response rates were significantly higher for all tofacitinib groups: 145 (39.9%; 5mg; p<0.001), 213 (59.2% (10mg; p<001), compared with placebo (11, 6.2%)		 Therapy-arm group: 494 (54.9%); 33 (3.7%)
Placebo: 90 (50.8%); 11 (6.2%)
Most frequent AEs: nasopharyngitis and upper respiratory tract infection
Tofacitinib; OPT Pivotal 266 Phase II, randomized placebo-controlled / 16 weeks 951 pts
Randomization to:

  • PBO: 196;

  • Tofacitinib 5mg BID: 382

  • Tofacitinib 10mg BID: 381

 At week 16, PGA response* rates in tofacitinib 5mg group and 10mg group were 173 (46.0%) and 221 (59.1%), respectively, significantly higher than placebo: 21 (10.9%) (P < 0.001 vs placebo in both groups)
PASI75 response rates were significantly higher for all tofacitinib groups: 173 (46.0%; 5mg; p<0.001), 223 (59.6% (10mg; p<001), compared with placebo (22, 11.4%).		 Therapy-arm group: 518 (54.5%); 30 (3.1%)
Placebo: 93 (47.4%); 6 (3.1%)
Most frequent AEs: nasopharyngitis and upper respiratory tract infection.
Tofacitinib; NCT0124159167 Phase II, randomised, multicentre, double-dummy, placebo-controlled, non-inferiority trial / 12 weeks 1101 pts
Randomization to

  • PBO: 107;

  • Tofacitinib 5mg BID: 329;

  • Tofacitinib 10mg BID: 330;

  • Etanercept 50mg twice weekly: 335

 At week 12, the proportions of PGA responders were 155 (47.1%), 225 (68.2%), 222 (66.3%) and 16 (15.0%) in the tofacitinib 5mg group, tofacitinib 10mg group, etanercept group, and placebo group, respectively
PASI75 response was reached by 130 (39.5%), 210 (63.6%), 197 (58.8%) and 6 (5.6%) subjects of the same groups, respectively.
For both coprimary endpoints, tofacitinib 10mg BID was non-inferior to etanercept and was superior to placebo, whereas tofacitinib 5mg BID did not meet the non-inferiority criteria versus etanercept but met the superiority criteria versus placebo.		 Therapy-arm group: 625 (56.8%); 28 (2.5%)
Placebo: 55 (51.4%); 4 (3.7%)
Etanercept 50mg twice weekly: 192 (57.3%); 11 (3.3%)
Most frequent AEs: nasopharyngitis and upper respiratory tract infection
Itacitinib; NCT0163408768 Phase II, randomized, double-blind, placebo-controlled, dose-escalation study / 4 weeks 50 pts
Randomization to

  • PBO: 12

  • Itacitinib 100mg QD: 9

  • Itacitinib 200mg QD: 9

  • Itacitinib 200mg BID: 9

  • Itacitinib 600mg QD: 11

 At week 4, a mean percentage reduction from baseline in sPGA of 22.2%, 29.4%, 35.2% 42.4% and 12.5% for 100mg QD (p =0.270 vs placebo), 200mg QD (p = 0.118), 200mg BID (p = 0.053), 600mg QD (p = 0.003) and placebo cohort was observed, respectively Therapy-arm group: 23 (46.0%); 0
Placebo: 4 (33.3%); 0
Most frequent AEs: nasopharyngitis, increased aspartate aminotransferase, headache and hypertriglyceridemia
Abrocitinib; NCT0220152469 Phase II, randomized, double-blind, placebo-controlled study / 4 weeks 59 pts
Randomization to

  • PBO: 14

  • Abrocitinib 200mg QD: 15

  • Abrocitinib 400mg QD: 16

  • Abrocitinib 200mg BID: 14

 At week 4, PASI75 was reached by 17%, 17%, 50% and 60% of patients receiving placebo, abrocitinib 200mg QD, abrocitinib 400mg QD and 200mg BID, respectively Therapy-arm group: 26 (44.1%); 3 (5.1%)
Placebo: 3 (21.4%); 0
Most frequent AEs: nausea and headache
Solcitinib; NCT0178266470 Phase IIa, randomized, placebo-controlled study / 12 weeks 60 pts
Randomization to:

  • PBO: 15

  • Solcitinib 100mg BID: 15

  • Solcitinib 200mg BID: 15

  • Solcitinib 400mg BID: 14

 At week 12, PASI 75 response was 0% in the placebo group compared with 13%, 25% and 57% in the 100mg, 200mg and 400mg solcitinib BID cohort, respectively Total AEs: NR
Discontinuation for AEs: NR
Most frequent AEs: headache, nasopharyngitis, nausea, diarrhoea, fatigue and upper abdominal pain
Baricitinib; NCT0149063271 Phase IIb, randomized, double-blind, multicountry,
placebo-controlled, dose-ranging study / 12 weeks		 271 pts
Randomization to:

  • PBO: 34

  • Baricitinib 2mg QD: 32

  • Baricitinib 4mg QD: 72

  • Baricitinib 8mg QD: 64;

  • Baricitinib10mg QD: 69

 At week 12, all baricitinib treated groups showed greater mean changes from baseline in their PASI scores (p<0.05) and (except 2mg) a higher rate of PASI50 than the placebo group Moreover, statistically significant PASI90 responses were achieved in the 8mg and 10mg groups at 8 and 12 weeks Therapy-arm group: 146 (53.9%); 10 (3.7%)
Placebo: 15 (44.1%); 0 (0%)
Most frequent AEs: nasopharyngitis, infections
Peficitinib; NCT0109686272 Phase IIa, randomized, double-blind, placebo-controlled,
sequential dose-escalation study / 6 weeks		 124 pts
Randomization to:

  • PBO: 29

  • Peficitinib 10mg BID: 19

  • Peficitinib 25mg BID: 21

  • Peficitinib 60mg BID: 19

  • Peficitinib 100mg BID: 17

  • Peficitinib 50mg QD: 19

 At week 6, PASI75 response was achieved by 5 (17.2%), 12 (63.2%), 10 (47.6%), 13 (68.4%), 13 (76.5%), 13 (76.5%), 9 (47.4%) patients receiving placebo, peficitinib 10mg BID, peficitinib 25mg BID, peficitinib 60mg BID, peficitinib 100mg BID, and peficitinib 50mg QD, respectively Therapy-arm group: 55 (44.3%); 3 (2.4%)
Placebo: 11 (37.9%); 0
Most frequent AEs: nasopharyngitis, diarrhoea, acne, back pain, and contact dermatitis
Deucravacitinib; NCT0293183873 Phase II, randomized, double-blind trial / 12 weeks 237 pts
Randomization to:

  • PBO: 45

  • Deucravacitinib 3mg QD: 44

  • Deucravacitinib 3mg BID: 44

  • Deucravacitinib 3mg BID: 45

  • Deucravacitinib 6mg BID: 45

  • Deucravacitinib 12mg QD: 44.

 At week 12, PASI75 was achieved by 3 (6.7%), 4 (9.1%), 17 (38.6%), 31 (68.9%), 30 (66.7%) and 33 (75.0%) patients, respectively, with a statistical significance in the 3mg QD, 3mg BID, 6mg BID, and 12mg QD cohort (p<0.001 vs placebo for all) Therapy-arm group: 172 (64.4%); 10 (3.7%)
Placebo: 23 (51.1%); 2 (4.4%)
Most frequent AEs: nasopharyngitis, headache, diarrhoea
Deucravacitinib; POETYK PSO-174 Phase II, randomized, double-blind, placebo-controlled / 16 weeks 666 pts
Randomization to:

  • PBO: 166

  • Deucravacitinib 6mg QD: 332

  • Apremilast 30mg BID: 168

 At week 16, 194 (58.4%) patients reached PASI75 in the deucravacitinib group compared with 21 (12.7%) in the placebo cohort (p<0.0001) and 59 (35.1%) in the apremilast group (p<0.0001) Therapy-arm group: 339 (50.9%); 23 (3.5%)
Placebo: 70 (42.2%); 7 (4.2%)
Apremilast 30mg BID: 93 (55.4%); 10 (6.0%)
Most frequent AEs: nasopharyngitis, headache, diarrhoea, upper respiratory tract infection
Deucravacitinib; POETYK PSO-275 Phase II, randomized, double-blind, placebo-controlled / 16 weeks 1020 pts
Randomization to:

  • PBO: 255

  • Deucravacitinib 6mg QD: 511

  • Apremilast 30mg BID: 254

 At week 16, 271 (53.0%) patients reached PASI75 at week 16 (primary outcome) in the deucravacitinib group compared with 24 (9.4%) in the placebo cohort (p<0.0001) and 101 (39.8%) in the apremilast group (p=0.0004) Therapy-arm group: 581 (57.0%); 35 (3.4%)
Placebo: 138 (54.1%); 9 (3.5%)
Apremilast 30mg BID: 150 (59.1%); 12 (4.7%)
Most frequent AEs: nasopharyngitis, headache, diarrhoea, upper respiratory tract infection
Brepocitinib; NCT0296901876 Phase IIa, randomized,
double-blind, placebo-controlled trial / 4 weeks		 212 pts
Randomization to

  • PBO: 23

  • Brepocitinib 30mg QD: 84

  • Brepocitinib 60mg QD: 105


At week 12:

  • Brepocitinib 60 to 30mg QD: 25

  • Brepocitinib 60 to 10mg QD: 29

  • Brepocitinib 60 to 100mg QW: 26

  • Brepocitinib 60 to PBO: 25

  • Brepocitinib 30mg QD: 29

  • Brepocitinib 30 to 10mg QD: 25

  • Brepocitinib 30 to 100mg QW: 30

  • PBO: 23

 At week 4, PASI reductions were similar in both the brepocitinib 60mg and 30mg induction dose groups. At week 12, PASI reductions were observed in all active treatment groups and were statistically significant compared with placebo in the 60 to 30mg QD treatment group, 60mg QD to 100mg once weekly treatment group, 30mg QD treatment group, 30- to 10mg QD treatment group, and 30mg QD to 100mg once weekly treatment group Therapy-arm group: 149 (70.3%); 13 (6.1%)
Placebo: 13 (56.5%); 0
Most frequent AEs: nasopharyngitis, upper respiratory tract infection
Ropsacitinib; NCT0389537277 Phase IIb, randomized, double-blind, placebo controlled, parallel-group study / 16 weeks 178 pts
Randomization to:

  • PBO: 45

  • Ropsacitinib 50mg QD: 22

  • Ropsacitinib 100mg QD: 23

  • Ropsacitinib 200mg QD: 45

  • Ropsacitinib 400mg QD: 43

 At week 16, a significantly greater proportion of participants achieved PASI90 (risk difference percentage) in the 200mg and 400mg groups (33.0%, p = 0.0004 and 46.5%, p<0.0001, respectively) versus placebo Therapy-arm group: 109 (61.2%); 9 (5.1%)
Placebo group: 23 (51.1%); 1 (2.2%)
Most frequent AEs: nasopharyngitis, upper respiratory tract infection, and higher blood pressure

Abbreviations: AE, adverse event; BSA, body surface area; Pt, patient; QD, once a day; BID, two times a day; QW, once a week; PBO, placebo.