Table 1.
Summary of included studies
| Study ID and design | Study population characteristics (across all treatment and placebo groups) | Intervention | Control | Concommitent therapies permitted for trial | Duration of treatment and follow up of included outcomes | outcomes assessed | Serious adverse events in max dose and placebo groups | Herpes zoster cases on max dose |
|---|---|---|---|---|---|---|---|---|
|
[28] Phase III RCT |
Mean age: 44.0 Percent male: 71 |
N = 332 Tofacitinib (Max. dose 10 mg, BID) |
N = 108 Placebo N = 336 Etanercept 50 mg 2x/wk (Data not included in analysis) |
None. 2 week washout for topical and UVB treatment and at least 4 weeks for systemic therapies | 12 weeks |
PASI75 sPGA |
5 (2%) on max dose; 2 (2%) on placebo |
2 |
|
[30] Phase II RCT |
Mean age: 48.4 Percent male: 64 |
N = 11 INCB039110 (Max. dose 600 mg, daily) |
N = 12 Placebo |
Stable dosing of topical therapy permitted. 4 week washout for unstable topical dosing, systemic therapies or phototherapy | 4 weeks |
PASI75 sPGA |
None | None |
|
[10] Phase III RCT |
Mean age: 49.8 Percent male: 45 |
N = 132 Tofacitinib (Max. Dose 10 mg, BID) |
N = 131 Placebo |
Methotrexate, sulfasalazine, leflunamide permitted with max doses. 4 week washout period for TNFi | 3 months before dose switch for another 3 months (only first 3 months data included), follow up at 2 weeks, 1 month, then monthly |
PASI75 ACR20 |
3 (2%) on max dose; 3 (2%) on placebo |
1 |
|
[31] Phase IIA RCT |
Mean age: 44.0 Percent male 64 |
N = 14 ASP015K (Max. dose 400 mg, daily) |
N = 14 Placebo |
None. 2 week washout period for topical therapies, 4 weeks for phototherapy and 4–12 weeks for systemic therapies | 4 weeks |
PASI75 sPGA |
1 (7%) on max dose considered to be treatment related | None |
|
[37] Phase III RCT |
Mean age: 50.8 Percent male: 48 |
N = 423 Upadacitinib (Max. dose 30 mg, daily) |
N = 423 Placebo N = 429 Adalimumab 40 mg SC q2wks (Data not included in analysis) |
≤ 2 Stable non-biologic DMARDs permitted with max doses. Patient may not be on both methotrexate and leflunamide. 4–12 week washout for TNFi, 2 weeks for topical therapy, 2–4 for phototherapy | 24 weeks |
PASI75 ACR20 |
26 (6.1%) on max dose; 13 (3.1%) on placebo |
5 |
|
[29] Phase III RCT |
Mean age: 47.7 Percent male: 44 |
N = 104 Tofacitinib (Max. dose 10 mg, BID) |
N = 105 Placebo N = 106 Adalimumab 40 mg SC q2wks (Data not Included in analysis) |
Methotrexate, sulfasalazine, leflunamide permitted with max doses. 6 month wash out for biologic DMARDs | 3 months before dose switch for another 9 months (only first 3 months’ data included) |
PASI75 ACR20 |
1 (1%) on max dose; 1 (1%) on placebo |
None |
|
[32] Phase II RCT |
Mean age: 49.0 Percent male: 45 |
N = 65 Filgotinib (Max. dose 200 mg, daily) |
N = 66 Placebo |
Methotrexate, sulfasalazine, leflunamide and hydroxychloroquine permitted with max dose. 4–12 week washout for TNFi, 2 weeks for topical therapy, 4 for phototherapy | 4 weeks |
PASI75 ACR20 |
1 (2%) on max dose | 1 |
|
[36] Phase III RCT |
Mean age: 53.4 Percent male: 46 |
N = 218 Upadacitinib (Max. dose 30 mg, daily) |
N = 212 Placebo |
≤ 2 Stable non-biologic DMARDs permitted with max doses. Patient may not be on both methotrexate and leflunamide. 4–12 week washout for TNFi, 2 weeks for topical therapy, 2–4 for phototherapy | 24 weeks |
PASI75 ACR20 |
18 (8%) on max dose; 4 (2%) on placebo | 8 |
|
[36] Phase IIB RCT |
Mean age: 44.3 Percent male: 63.5 |
N = 49 Tofacitinib (Max. dose 15 mg, BID) |
N = 50 Placebo |
None. 4–12 week washout period for DMARDs, 2 weeks for topical therapy, 2–4 weeks for phototherapy | 4 weeks |
PASI75 sPGA |
1 (1%) on max dose; 1 (1%) on placebo |
None |
|
[26] Phase IIA RCT |
Mean age: 48.1 Percent male: 78.2 |
N = 17 ASP015K (Max. dose 100 mg, BID) |
N = 29 Placebo |
None. At least 8 week washout period for DMARDs, 1–2 weeks for topical therapies, 8 weeks for phototherapy | 6 weeks | PASI75 | None | None |
|
[26] Phase III RCT OPT 1 |
Mean age: 45.8 Percent male: 70.8 |
N = 360 Tofacitinib (Max. dose 10 mg, BID) |
N = 177 Placebo |
None. 2–4 week washout for topical therapies or phototherapy, 4 weeks for etanercept and non-biologic DMARDs, 8–12 weeks for biologic DMARDs | 16 weeks |
PASI75 sPGA |
10 (3%) on max dose; 5 (3%) on placebo |
5 |
|
[33] Phase III RCT OPT 2 |
Mean age: 45.4 Percent male: 67.6 |
N = 381 Tofacitinib (Max. dose 10 mg, BID) |
N = 196 Placebo |
None. 2–4 week washout for topical therapies or phototherapy, 4 weeks for etanercept and non-biologic DMARDs, 8–12 weeks for biologic DMARDs | 16 weeks |
PASI75 sPGA |
5 (1%) on max dose; 2 (1%) on placebo |
1 |
|
[36] Phase IIB RCT |
Mean age: 47.3 Percent male: 72.7 |
N = 69 (Max. dose 10 mg, daily) Baricitinib |
N = 34 Placebo |
None. 8 week washout period for biologic DMARDs, 4 weeks for non-biologic DMARDs or phototherapy, 2 weeks for topical therapies | 12 weeks before dose switch for another 12 weeks (only first 12 weeks’ data included) | PASI75 |
1 (1%) on max dose; 1 (3%) on placebo |
None |
|
[35] Phase II RCT |
Mean age: 45.6 Percent male: 68.0 |
N = 16 Tofacitinib (Max. dose 400 mg daily) |
N = 14 Placebo |
None. 4 week washout period for prohibited medications (undefined in manuscript) | 4 weeks |
PASI75 sPGA |
0 (0%) on max dose; 1 (3%) on placebo |
None |
|
[27] Phase III RCT |
Mean age: 41.1 Percent male: 72.9 |
N = 90, Tofacitinib (Max. dose 10 mg, BID) |
N = 88 Placebo |
None. Washout periods not included in manuscript | 16 weeks before dose switch for another 36 weeks (only first 16 weeks’ data included) |
PASI75 sPGA |
None | 3 |