Table 1.
Scalp psoriasis-specific efficacy data for biologic and small-molecule agents
| Agent | Study name | Comparison | Dosing | Mean percent PSSI improvement | PSSI 75 | PSSI 90 | PSSI 100α/ PSSI score of 0β | ScPGA 0/1 | Safety | Other |
|---|---|---|---|---|---|---|---|---|---|---|
| TNF-alpha inhibitors | ||||||||||
| Etanercept | Moderate to severe plaque psoriasis with scalp involvement: a randomized, double-blind, placebo-controlled study of etanercept [34] | Placebo |
Etanercept 50 mg twice weekly for 12 weeks, followed by etanercept 50 mg once weekly and placebo once weekly (etanercept) Placebo twice weekly for 12 weeks, followed by etanercept 50 mg twice weekly for 12 weeks (placebo/ etanercept) |
(Week 12): Etanercept: 86.6% ± 18.0**** Placebo/etanercept: 20.4% ± −39.9 (Week 24): Etanercept: 90.6% ± 13.1 Placebo/etanercept: 79.1% ± 33.6 (p < 0.0001)**** |
(Week 12): Etanercept: 86.0% **** Placebo/etanercept: 11.0% PSSI 75 (wk 24): Etanercept: 86.0% Placebo/etanercept: 72.0% (p < 0.0001)**** |
Rates of adverse events comparable between etanercept and placebo at week 12 and between etanercept and placebo/etanercept at week 24 | ||||
| Adalimumab | Adalimumab for the treatment of moderate to severe psoriasis: subanalysis of effects on scalp and nails in the BELIEVE study [35] | None, statistical comparison was with baseline |
Randomized to receive adalimumab 80 mg at week 0 and 40 mg Q2W until week 15 plus topical C/B ointment or adalimumab plus vehicle for 16 weeks/ Topical C/B treatment specifically avoided in the scalp and nails All groups combined for analysis |
77.2% ± 96.9% (week 16) |
Of all patients receiving adalimumab (both scalp and nail psoriasis patients), 61.8% experienced an AE Majority of AEs were classified as mild or moderate. Headache and nasopharyngitis were the most common |
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| Effectiveness of adalimumab in the treatment of scalp and nail affection in patients with moderate to severe plaque psoriasis in routine clinical practice [36] | None, statistical comparison was to baseline | Decision to treat with adalimumab was made independent of participation in the study, but the majority (96.6%) received adalimumab 40 mg Q2W dosing schedule | 94.8% (1 year) | 71.7% (1 year)α | Of all patients receiving adalimumab (scalp and nail psoriasis patients), 9.6% had an AE. Skin and subcutaneous tissue disorders and infection/ infestations were most common | DLQI scores ≤ 5: improved 94.0% (1 year) | ||||
| Infliximab | Treatment effect of adalimumab and infliximab in Japanese psoriasis patients: results in a single community‐based hospital [37] | Adalimumab | Patients were allocated, based on patient preference, to adalimumab 80 mg at week 0, and then 40 mg every other week from week 2 through week 24 or infliximab 5 mg/kg at weeks 0, 2, 6, 14, and 22 |
(Week 16) Adalimumab: 54.5% Infliximab: 90.0% (Week 24) Adalimumab: 54.5% Infliximab: 70.0% |
(Week 16) Adalimumab: 45.5% Infliximab: 70.0% (Week 24) Adalimumab: 54.5% Infliximab: 70.0% |
No injection-site reactions with adalimumab nor infusion reactions with infliximab Mild upper respiratory tract infection in 19.0% of patients, no serious AEs |
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| Scalp psoriasis and biologic agents: a retrospective, comparative study from a tertiary psoriasis referral centre [38] | Etanercept, adalimumab, and ustekinumab | Received infliximab 5 mg/kg (IV) at weeks 0, 2, 6, 8, and every 8 weeks after; etanercept 50 mg twice weekly for 12 weeks and once weekly after; adalimumab 80 mg at week 0, 40 mg at week 1, and 40 mg Q2W after; ustekinumab 45 mg or 90 mg at week 0 and week 4, and every 12 weeks after |
(Week 12) Infliximab: 90.8% Etanercept: 72.2% Adalimumab: 73.1% Ustekinumab: 88.7% (Week 48) Infliximab: 94.35% Etanercept: 83.16% Adalimumab: 89.09% Ustekinumab: 94.91% |
(Week 12) Infliximab: 91.4% Etanercept: 33.3% Adalimumab: 61.5% Ustekinumab: 92.6% (Week 48) Infliximab: 91.4% Etanercept: 70% Adalimumab: 92.3% Ustekinumab: 97.5% |
(Week 12) Infliximab: 74.2% Etanercept: 20.0% Adalimumab: 43.5% Ustekinumab: 80.4% (Week 48) Infliximab: 80.0% Etanercept: 50.0% Adalimumab: 69.2% Ustekinumab: 85.3% |
Minor AEs, none that required discontinuation of the study | ||||
| Certolizumab pegol | No specific scalp psoriasis clinical data outcomes | |||||||||
| IL-17 inhibitors | ||||||||||
| Brodalumab | Brodalumab, a human anti-interleukin-17-receptor antibody in the treatment of Japanese patients with moderate-to-severe plaque psoriasis: efficacy and safety results from a phase II randomized controlled study [39] | Placebo | Randomized to receive brodalumab 70 mg, 140 mg, or 210 mg or placebo at baseline and weeks 1, 2, 4, 6, 8, and 10 |
(Week 12) Brodalumab 70 mg: 38.3% ± 50.3 Brodalumab 140 mg: 73.8% ± 41.2*** Brodalumab 210 mg: 94.5% ± 14.8*** Placebo: 12.6 ± 63.0 (p < 0.001)*** |
AE reported in 44.7% of placebo, 53.8% of 70 mg brodalumab, 56.8% of 140 mg brodalumab, and 73.0% of 210 mg brodalumab Most common AEs in brodalumab group were nasopharyngitis, diarrhea, and upper respiratory tract inflammation |
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| Efficacy of brodalumab in the treatment of scalp and nail psoriasis: results from three phase 3 trials (AMAGINE -1) [40] | Placebo | Received either brodalumab 210 mg Q2W or placebo through week 12 |
(Week 12) Brodalumab: 92.8%*** Placebo: 14.4% (p < 0.001)*** |
(Week 12) Brodalumab: 89%*** Placebo: 9.5% (p < 0.001)*** |
(Week 12)α Brodalumab: 63.4%*** Placebo: 3.2% (p < 0.001)*** |
No specific safety data reporting for scalp post hoc analysis | ||||
| Ixekizumab | Improvement of scalp and nail lesions with ixekizumab in a phase 2 trial in patients with chronic plaque psoriasis [44] | Placebo | Randomized to receive ixekizumab 10, 25, 75, or 150 mg or placebo at weeks 0, 2, 4, 8, 12, and 16. In the OLE, all received ixekizumab 120 mg Q4W |
(wk 20) Ixekizumab 10 mg: 16.5% Ixekizumab 25 mg: 75.3%** Ixekizumab 75 mg: 83.7%** Ixekizumab 150 mg: 82.2%*** Placebo: 18.8% OLE (week 48) Placebo/ixekizumab: 98.1%*** Ixekizumab/ixekizumab: 87.5%*** (Compared with baseline) (p < 0.01)** (p < 0.001)*** |
OLE (week 48)β Placebo/ixekizumab: 81.3% Ixekizumab/ixekizumab: 77.3% |
No specific safety data reporting for scalp post hoc analysis | ||||
| Sustained response with ixekizumab treatment of moderate-to-severe psoriasis with scalp involvement: results from three phase 3 trials (UNCOVER-1, UNCOVER-2, UNCOVER-3) [45] | Placebo and etanercept |
UNCOVER-1, -2, -3 Randomized to receive ixekizumab 80 mg Q2W (IXEQ2W) or Q4W (IXEQ4W) after starting dose of 160 mg, or placebo until week 12 UNCOVER -2,-3 Also included a treatment arm with etanercept 50 mg biweekly until week 12 A blinded maintenance period occurred through 60 weeks in UNCOVER -1, -2 All patients received ixekizumab Q4W in an OLE in UNCOVER -3 |
(Week 12) IXEQ4W: 88.5%*** IXEQ2W: 93.0%*** Etanercept: 72.4% Placebo: 2.8% (p < 0.001)*** versus placebo and etanercept |
(Week 12) IXEQ4W: 83.6%*** IXEQ2W: 89.9%*** Etanercept: 67.6% Placebo: 12.7% (p < 0.001)*** versus placebo and etanercept OLE UNCOVER 3 (week 60) IXEQ4W/IXEQ4W: 84.6% IXEQ2W/IXEQ4W: 88.1% |
(Week 12) IXEQ4W: 75.6%*** IXEQ2W: 81.7%*** Etanercept: 55.5% Placebo: 7.6% (p < 0.001)*** versus placebo and etanercept OLE UNCOVER 3 (week 60) IXEQ4W/IXEQ4W: 80.1% IXEQ2W/IXEQ4W: 83.9% |
(Week 12)α IXEQ4W: 68.9%*** IXEQ2W: 74.6%*** Etanercept: 48.1% Placebo: 6.7% (p < 0.001)*** versus placebo and etanercept OLE UNCOVER 3 (wk 60)α IXEQ4W/IXEQ4W: 77.4% IXEQ2W/IXEQ4W: 80.5% |
No safety evaluation completed in just scalp psoriasis study participants. AE rates were similar in all treatment arms in the three studies | |||
| Efficacy and safety of continuous every-2-week dosing of ixekizumab over 52 weeks in patients with moderate-to-severe plaque psoriasis in a randomized phase III trial (IXORA-P) [46] | None, statistical comparison with other dosing regimens | Randomized at a 2:1:1 ratio to continuous IXEQ2W, continuous IXEQ4W, or dose adjustment per protocol, IXEQ4W/Q2W, each with a 160-mg starting dose |
(Week 52)β IXEQ4W:70.3% IXEQ2W:76.9%* IXEQ4W/Q2W:72.6% (p < 0.05)* versus IXEQ4W |
AE rates were similar across all three groups Most AEs were mild to moderate, and the most common AEs were upper respiratory infection, nasopharyngitis, injection‐site reaction (ISR), headache, hypertension, and urinary tract infection |
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| Secukinumab | The effect of secukinumab on moderate-to-severe scalp psoriasis: results of a 24-week, randomized, double-blind, placebo-controlled phase 3b study (SCALP) [41] | Placebo | Randomized to subcutaneous secukinumab 300 mg or placebo at baseline, weeks 1, 2, and 3, and then every Q4W from weeks 4 to 20 |
(Week 12) Secukinumab:71.0% Placebo: 16.7% |
(Week 12) Secukinumab: 52.9%*** Placebo: 2.0% (p < 0.001)*** (Week 24) Secukinumab: 58.8% |
(Week 12)α Secukinumab: 35.3%*** Placebo: 0.0% (p < 0.001)*** (Week 24)α Secukinumab: 47.1% |
72.5% in the secukinumab and 48.0% in the placebo group experienced an AE Most common AEs include nasopharyngitis, upper respiratory tract infection, cough, and contact dermatitis |
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| Secukinumab improves scalp pain, itching, scaling and quality of life in patients with moderate-to-severe scalp psoriasis [42] | Placebo | Randomized to secukinumab 300 mg or placebo at baseline, week 1, 2, and 3, and then every 4 weeks | No specific safety data reported for this study |
Scalp pain/itching/scaling (Week 12) Secukinumab Pain: −1.98*** Itching: −4.07*** Scaling: −5.76*** Placebo Pain: 0.61 Itching: −0.04 Scaling: −0.95 (p < 0.001)*** |
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| Real world data from the use of secukinumab in the treatment of moderate-to-severe psoriasis, including scalp and palmoplantar psoriasis: a 104-week clinical study [43] | None, statistical comparison was with baseline | Real-world subjects were recruited if being treated with the recommended dose of 300 mg secukinumab |
98.7% (week 16) 86.0% (week 52) 100% (week 104) |
During first 16 weeks, 7.2% of patients experienced an AE Safety comparable to secukinumab clinical trials All drug-related AEs were mild to moderate |
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| IL-12/IL-23 inhibitor | ||||||||||
| Ustekinumab | See infliximab and risankizumab | |||||||||
| IL-23 inhibitors | ||||||||||
| Guselkumab | Efficacy of guselkumab compared with adalimumab and placebo for psoriasis in specific body regions: a secondary analysis of 2 randomized clinical trials [47] | Adalimumab | Randomized to receive guselkumab 100 mg (week 0 and 4, then every 8 weeks); placebo followed by guselkumab 100 mg, starting at week 16; or adalimumab 80 mg at week 0 and 40 mg at week 1 followed by Q2W | No specific safety data reporting for scalp post hoc analysis |
Scalp-specific IGA 0/1 (Week 16) Guselkumab: 81.8%*** (compared with placebo) Placebo: 12.4% Adalimumab: 69.0% (Week 24) Guselkumab: 85%*** Adalimumab: 68.5% (p < 0.001)*** |
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| Risankizumab | Risankizumab versus ustekinumab for moderate-to-severe plaque psoriasis [48] | Ustekinumab | Randomized to receive risankizumab (a single 18 mg dose at week 0 or 90 mg /180 mg doses at weeks 0, 4, and 16) or ustekinumab (45 mg or 90 mg) at weeks 0, 4, and 16 |
(Week 12) Risankizumab 90 mg: 90.0% Risankizumab 180 mg: 94.0% Ustekinumab: 82.0% |
81.0% in 18-mg risankizumab group, 80.0% in 90-mg risankizumab group, 69.0% in 180-mg risankizumab group, and 72.0% in ustekinumab group reported AEs Most common AE in all groups was nasopharyngitis |
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| Mirikizumab | Efficacy and safety of mirikizumab (LY3074828) in the treatment of moderate-to-severe plaque psoriasis: results from a randomized phase II study [49] | Placebo | Randomized at a 1:1:1:1 ratio to receive mirikizumab 30 mg, 100 mg, 300 mg, or placebo |
(Week 16)β Mirikizumab 30 mg: 43.0%*** Mirikizumab 100 mg: 75.0%*** Mirikizumab 300 mg: 51.0%*** Placebo: 6.0% (p < 0.001)*** |
Percentage of patients reporting AEs in each study group was comparable Most common AE included viral upper respiratory tract infections, injection-site pain, hypertension, and diarrhea |
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| PDE4 inhibitor | ||||||||||
| Apremilast | Apremilast, an oral phosphodiesterase 4 inhibitor, in patients with difficult-to-treat nail and scalp psoriasis: results of 2 phase III randomized, controlled trials (ESTEEM 1 and ESTEEM 2) [50] | Placebo |
Randomized (2:1) to apremilast 30 mg or placebo BID Placebo patients switched to apremilast from week 16 through week 32, followed by a randomized withdrawal phase to week 52 |
ESTEEM 1 (week 16): 46.5%**** Placebo: 17.5% ESTEEM 2 (week 16): 40.9%**** Placebo: 17.2% (p < 0.0001)**** |
Most AEs were mild to moderate No new significant AEs occurred with continued apremilast exposure |
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| The efficacy and safety of apremilast, etanercept and placebo in patients with moderate-to-severe plaque psoriasis: 52-week results from a phase IIIb, randomized, placebo-controlled trial (LIBERATE) [51] | Placebo and etanercept | Randomized to placebo, apremilast 30 mg BID, or etanercept 50 mg QW through week 16. After week 16, all patients were continued or switched to apremilast until week 52 |
(Week 16) Apremilast: 44.4% (p = 0.0458) Etanercept: 50.0% (p = 0.0083) Placebo: 25.9% (Week 52) Apremilast: 53.1% Etanercept/apremilast: 60.4% Placebo/apremilast: 52.0% |
Majority of AEs were mild to moderate Most common AEs include mild-to-moderate nausea, diarrhea, headaches, upper respiratory tract infections, and nasopharyngitis |
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| Safety and efficacy of apremilast through 104 weeks in patients with moderate to severe psoriasis who continued on apremilast or switched from etanercept treatment: findings from the LIBERATE study [52] | Placebo and etanercept | Randomized to placebo, apremilast 30 mg BID, or etanercept 50 mg QW through week 16. After week 16, all patients were continued or switched to apremilast until week 104 |
(Week 104) Apremilast: 59.2% Etanercept/apremilast: 56.6% Placebo/apremilast: 50.0% |
Majority of AEs were mild to moderate Most common AEs include mild-to-moderate nausea, diarrhea, headaches, upper respiratory tract infections, and nasopharyngitis |
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| Efficacy and safety of apremilast in systemic- and biologic-naive patients with moderate plaque psoriasis: 52-week results of UNVEIL [53] | Placebo | Randomized to receive apremilast 30 mg BID or placebo until week 16; then all patients were continued on (apremilast/apremilast) or were switched to apremilast (placebo/apremilast) through week 52 |
(Week 16) Apremilast: 38.4% Placebo: 20.0% (p = 0.0178) (Week 52) Apremilast/apremilast: 47.7% Placebo/apremilast: 46.9% |
Safety profile comparable to other clinical studies Most common AEs include diarrhea, nausea, headache, nasopharyngitis, upper respiratory tract infection, vomiting, and decreased appetite |
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| Efficacy and safety of apremilast in patients with moderate to severe plaque psoriasis of the scalp: results of a phase 3b, multicenter, randomized, placebo-controlled, double-blind study (STYLE) [54] | Placebo | Randomized patients to apremilast 30 mg twice daily or placebo for 16 weeks, and at week 16, all patients continued or switched to apremilast 30 mg twice daily through week 32 |
(Week 16) Apremilast: 43.3%**** Placebo: 13.7% (p < 0.0001)**** |
AEs occurred in 67.5% of apremilast group and 51% of placebo group Most common AEs included diarrhea, nausea, headache, and vomiting |
Scalp itch NRS 4-point or greater improvement (week 16): Apremilast: 47.1% Placebo: 21.2% Mean improvement from baseline in DLQI total score (week 16) Apremilast: −6.7 Placebo: −3.8 (p ≤ 0.0001) |
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PSSI Psoriasis Scalp Severity Index, ScPGA scalp Physician Global Assessment, DLQI Dermatology Life Quality Index, PDE4 inhibitor phosphodiesterase 4 inhibitor, Q2W every 2 weeks, Q4W every 4 weeks, BID twice daily, IV intravenous, OLE open-label extension, scalp-specific IGA Scalp-specific Investigator's Global Assessment, AE adverse event