Biologic therapies for nail psoriasis.
| Study | Therapy | Study Type and Population | Outcome Measure | Baseline | Results |
|---|---|---|---|---|---|
| Demirsoy 201314, Turkey | IFX, ADM, or ETN vs MTX, vs narrow-band UVB (NB-UVB), vs acitretin, vs no treatment | Comparative, N = 87 | NAPSI at wks 0, 16 | Any type of skin psoriasis with nail involvement | Mean NAPSI score at wk 0: Biologics: 36.5, MTX: 25.1, NB-UVB: 22.5, Acitretin: 23.8, Control: 21.3; wk 16: Biologics: 7.9, p = significant c/w control but specific value NR, MTX: 20.5, NS c/w control, NB-UVB: 17, NS c/w control, Acitretin: 17.9, NS c/w control; Control: 18.3 |
| Sola-Ortigosa 201217, Spain | ADM (initial 80-mg dose SQ at wk 0 → 40 mg SQ at wk 1, then eow) | Retrospective, N = 15 | NAPSI at wks 0, 24 | Moderate-to-severe plaque psoriasis, failed to respond to conventional systemic treatments or other biological agents, in which ADM therapy was indicated | Mean NAPSI score at baseline vs wk 24: 18.9 ± 12.2 vs 8.2 ± 4.7, p = 0.001 |
| Leonardi 201118, USA, Canada | ADM (initial 80-mg dose SQ at wk 0 → 40 mg SQ eow wks 1–15; → Pbo at wk 16 → 40 mg SQ eow wks 17–27), vs Pbo (crossover to ADM 80 mg SQ at wk 16 → 40 mg SQ eow, wks 17–27) | Randomized, Pbo-controlled, double-blind (16 wks); open-label 12-wk extension, N = 72 | NAPSI at wks 0, 8, 16, 28 | Chronic plaque psoriasis on hands and/or feet with PGA of hands/feet of at least “moderate” severity | Mean NAPSI score (target nail): Baseline: ADM: 3.9 ± 2.0; Pbo: 3.3 ± 1.8; Mean % NAPSI improvement: Wk 16: ADM: 50%, Pbo: 8%, p = 0.02 btwn groups; Wk 28: ADM: 54%, Pbo (switched to ADM at wk 16): 38% |
| Rigopoulos 201019, Greece | ADM (initial 80-mg dose SQ at wk 0 → 40 mg SQ at wk 1 → 40 mg SQ q2wks) | Open-label, N = 21 | Mean NAPSI at wks 0, 12, and 24 | Severe plaque psoriasis with nail involvement | Mean NAPSI score at baseline: Psoriasis patients: Fingernails: 10.57 ± 1.21; Toenails: 14.57 ± 2.50, PsA patients: Fingernails: 23.86 ± 2.00; Toenails: 29.29 ± 2.87, Mean NAPSI score at wk 24: Psoriasis patients: Fingernails: 1.57 ± 0.20; Toenails: 4.14 ± 1.58, PsA patients: Fingernails: 3.23 ± 0.32; Toenails: 10.00 ± 1.40 |
| Van den Bosch 201020, Belgium, Germany, France, UK, Norway, Denmark, Sweden, Finland, Ireland | ADM (40 mg SQ eow ×12 wks) | Open-label, N = 442 | NAPSI at wks 0, 12, 20 | Diagnosis of PsA, previous treatment with > 1 DMARD | Improvement > 50% in NAPSI score at wk 12 (in patients with baseline NAPSI > 10): 54.2%, Median NAPSI: Wk 12: 5, Wk 20: 1 |
| Rudwaleit 201021, Germany | ADM (40 mg SQ eow ×12 wks) | Open-label, N = 442 (with PsA) | NAPSI at wks 0, 12 | History of anti-TNF treatment [IFX, ETN, or both] and failure of 1 or more DMARD for PsA | Median change in NAPSI score at wk 12: No prior ETN/IFX: −6 (range −14 to −2), Prior ETN/IFX: −6 (range −15 to −1), NS btwn groups |
| Ozmen 201322, Turkey | ADM (initial 80-mg dose SQ at wk 0 → 40 mg SQ eow starting wk 1), vs ETN (50 mg SQ biw ×12 wks → 50 mg SQ qw), vs IFX (5 mg/kg IV at wks 0, 2, 6, then q8wks to wk 46) | Randomized, open-label, N = 28 | NAPSI at wks 0, 12, 24, 36, 48 | Moderate-to-severe nail psoriasis, failed other systemic therapies | Mean improvement in NAPSI score at week 48: ADM: 53.8%, ETN: 57.3%, IFX: 40.4%, CI not reported; authors report difference NS |
| Saraceno 201323, Italy | ADM (initial 80-mg dose SQ at wk 0 → 40 mg SQ eow wks 1–24), vs ETN (50 mg SQ biw ×12 wks → 25 mg SQ biw ×12 wks), vs IFX (5 mg/kg IV at wks 0, 2, 6, then q8wks to wk 24) | Open-label, N = 60 | NAPSI at wks 0, 14, 24 | Moderate-to-severe plaque psoriasis or PsA, failed ≥ 2 systemic conventional treatments, NAPSI score > 15 | Mean NAPSI score at baseline vs wk 14: ADM: 33.1 ± 14.9 vs 21.0 ± 8.91, p ≤ 0.01, ETN: 34.8 ± 12.38 vs 23.6 ± 10.43, p ≤ 0.01, IFX: 33.3 ± 9.76 vs 14.9 ± 4.20, p ≤ 0.01; Mean NAPSI score at wk 14 vs wk 24: ADM: 21.0 ± 8.91 vs 11.4 ± 4.6, p ≤ 0.0002, ETN: 23.6 ± 10.43 vs 10.6 ± 5.25, p ≤ 0.0016, IFX: 14.9 ± 4.20 vs 3.1 ± 3.27, p ≤ 0.00001; At week 14, IFX had better efficacy than ADM and ETN, p < 0.05 |
| Kyriakou 201324, Greece | ADM (initial 80-mg dose SQ at wk 0 → 40 mg SQ at wk 1 → 40 mg SQ q2wks thereafter), vs ETN (50 mg SQ biw ×12 wks → 50 mg SQ qw), vs IFX (5 mg/kg IV at wks 0, 2, 8 then q8wks to wk 46) | Open-label, retrospective, N = 12 | NAPSI at wks 0, 12, 24, 48 | Moderate-to-severe plaque psoriasis, PASI > 10, NAPSI > 10 | Mean NAPSI score at baseline vs wk 48: IFX: 80.50 ± 45.19 vs 4.58 ± 3.67, p = 0.002, ADM: 82.64 ± 42.35 vs 9.57 ± 4.51, p = 0.001, ETN: 82.76 ± 48.06 vs 6.61 ± 4.29, p = 0.001 |
| Mease 201425, North America, Latin America, Western Europe, Central/Eastern Europe | CZP (200 mg SQ q2wks) vs CZP (400 mg SQ q4wks) vs Pbo (0.9% saline) | Randomized, double-blind, Pbo-controlled to week 24, dose-blind to week 48, open-label to week 216, N = 409 (73.3% with nail disease at baseline) | Modified NAPSI (target fingernail) at wks 0, 24 | Patients with adult-onset PsA of at least 6 months’ duration, active joint disease, failed ≥ 1 DMARD, documented history of psoriasis, nail disease at baseline | Mean NAPSI score at baseline: CZP 200 mg: 3.1 ± 1.8, CZP 400 mg: 3.4 ± 2.2, Pbo: 3.4 ± 2.2; Modified NAPSI score change from baseline at wk 24: CZP 200 mg: −1.6, p = 0.003 c/w pbo, CZP 400 mg: −2.0, p < 0.001 c/w pbo, Pbo: −1.1 |
| Ortonne 201326, Austria, France, Greece, Italy | ETN (50 mg SQ biw ×12 wks → 50 mg qw ×12 wks [biw/qw]), vs ETN (50 mg SQ qw ×24 wks [qw/qw]) | Randomized, open-label, N = 72 | NAPSI at wks 0, 12, 24 | Moderate-to-severe plaque psoriasis, previously failed 1 form of systemic therapy for nail psoriasis | Mean improvement in NAPSI score (target nail) at baseline vs wk 24: biw/qw: 6.0 vs 1.7, p < 0.0001, qw/qw: 5.8 vs 1.4, p < 0.0001 |
| Luger 200927, Germany, UK, Belgium | ETN (25 mg SQ biw ×54 wks), vs Interrupted ETN (initial 50-mg dose SQ biw ×12 wks max or until PGA ≤ 2; if relapse (PGA ≥ 3), 25 mg ETN SQ biw until response) | Randomized, open-label, N = 771 (564 with nail psoriasis) | NAPSI at wks 0, 12, 24, 56, or at time of discontinuation | Psoriasis with BSA ≥ 10%, PGA ≥ 3, previously failed usual care | Mean NAPSI score at baseline vs wk 12 (pooled continuous and interrupted therapy): Patients with nail psoriasis: 4.64 vs 3.30, p < 0.0001 |
| Kavanaugh 200928, USA, Canada, Belgium, Poland, Spain, UK | Golimumab (GLB, 50 mg SQ q4wks ×20 wks), vs GLB (100 mg SQ q4wks ×20 wks), vs Pbo | Randomized, double-blind, Pbo-controlled phase 3, N = 405 | NAPSI at wks 0, 14, 24 | Same as above | Mean NAPSI score (target nail) at baseline: GLB 50 mg: 4.7 ± 2.2, GLB 100 mg: 4.6 ± 2.1, Pbo: 4.4 ± 2.2; Median % change in NAPSI: Wk 14: GLB 50 mg: 25%, GLB 100 mg: 43%, Pbo: 0%; Wk 24: GLB 50 mg: 33%; GLB 100 mg: 54%; Pbo: 0% |
| Kavanaugh 201229, USA, Canada, Belgium, Poland, Spain, UK | GLB (50 mg SQ q4wks ×20 wks), vs GLB (100 mg SQ q4wks ×20 wks), vs Pbo | Randomized, double-blind, Pbo-controlled phase 3, N = 405 | NAPSI at wk 0, 52 | Patients negative for rheumatoid factor, had active PsA and plaque psoriasis despite therapy with DMARD or NSAID, no previous treatment with TNF antagonists, rituximab, natalizumab, or cytotoxic agents | Mean NAPSI score (target nail) at baseline: GLB 50 mg: 4.7 ± 2.2, GLB 100 mg: 4.6 ± 2.1, Pbo: 4.4 ± 2.2; Mean % change in NAPSI score at wk 52: GLB 50 mg: 51.6 ± 46.8, GLB 100 mg: 65.8 ± 51.9, GLB pooled: 59.2 ± 50.0, Pbo: 56.2 ± 48.1 |
| Fabroni 201130, Italy | IFX (5 mg/kg IV at wks 0, 2, 6, then q8wks to wk 38) | Open-label, uncontrolled retrospective study without comparison group, N = 121 (61 with nail psoriasis) | NAPSI at wks 0, 14, 28, 38 | Moderate-to-severe psoriasis (PASI ≥ 10) or PsA for ≥ 1 year with nail involvement, previously failed ≥ 2 traditional systemic therapies | Mean NAPSI score at baseline: 49.7 ± 26.0; Mean NAPSI score at wk 14: 18.6 ± 9.4, wk 22: 9.5 ± 4.7, wk 38: 7.2 ± 4.9 |
| Torii 201131, Japan | IFX (5 mg/kg IV at wks 0, 2, 6, then q8wks to wk 46) | Open label, uncontrolled, N = 64 (56 with nail psoriasis) | NAPSI in target worst nail | Patients with plaque psoriasis, PsA, pustular psoriasis (excluding localized) or psoriatic erythroderma, PASI ≥ 12, BSA ≥ 10% | Mean NAPSI score at baseline (all underlying diseases): 4.4 ± 1.9; Mean NAPSI score (all underlying diseases) at wk 10: 3.3 ± 1.7, wk 26: 1.8 ± 1.9, wk 50: 1.9 ± 2.1 |
| Reich 201032 Germany, Netherlands, Switzerland, Canada, UK | IFX (5 mg/kg IV at wks 0, 2 and 6 → 5 mg/kg IV q8wks to wk 46), vs Pbo (crossover to IFX at wks 24, 26, 30, 38, and 46) | Randomized, double-blind, pbo-controlled, phase 3, N = 373 | NAPSI at wks 0, 10, 24, 38 and 50 | Moderate-to-severe plaque psoriasis ≥ 6 months, PASI ≥ 12, BSA ≥ 10% | Mean % improvement in NAPSI score (among all treated with IFX) at wk 10: 28.3%, wk 24: 61.4%, wk 50: 67.8% |
| Torii 201033, Japan | IFX (5 mg/kg IV at wks 0, 2, 6, 14 then q8wks to wk 62), vs Pbo [crossover at wk 16 with IFX (5 mg/kg) IV at wks 18, 22, then q8wks to wk 62] | Randomized, double-blind, pbo-controlled, phase 3, N = 54 | NAPSI at wks 0, 10, 14, 26, 42, 66 | Moderate-to-severe plaque psoriasis ≥ 6 months, PASI ≥ 12, BSA ≥ 10% | Mean change in NAPSI score (change from baseline) at wk 10: IFX: 1.4 ± 2.2, Pbo: −0.3 ± 1.0; wk 14: IFX: 1.6 ± 2.0, Pbo: −0.6 ± 0.8; wk 26: IFX: 2.2 ± 2.3, Pbo → IFX: 0.7 ± 1.3; wk 42: IFX: 2.1 ± 2.0, Pbo → IFX: 1.9 ± 0.6; wk 66: IFX: 2.6 ± 2.0, Pbo → IFX: 2.4 ± 1.0 |
| Rich 200834, USA; Germany; UK | IFX (5 mg/kg IV at wks 0, 2 and 6 → 5 mg/kg IV q8wks to wk 46), vs Pbo (crossover to IFX at wks 24, 26, 30, 38, and 46) | Randomized, double-blind, pbo-controlled, phase 3, N = 373 (305 with nail psoriasis) | NAPSI at wks 0, 10, 24 | Psoriasis for ≥ 6 months, PASI ≥ 12, BSA ≥ 10% with nail involvement | Mean NAPSI score at baseline: IFX: 4.6 ± 2.0, Pbo: 4.3 ± 1.9; Mean % improvement in NAPSI score: wk 10: IFX: 26.8%, Pbo: −7.7%, p < 0.001 btwn groups; wk 24: IFX: 57.2%, Pbo: −4.1%, p < 0.001 btwn groups |
| Rigopoulos 200835, Greece | IFX (5 mg/kg IV at wks 0, 2, 6, then q8wks) | Nonrandomized, open-label, N = 18 | NAPSI at wks 0, 14, 22, 30, and 38 | Psoriasis patients with nail involvement scheduled to start IFX treatment | Mean NAPSI score at baseline vs wk 38: 55.78 ± 18.57 vs 3.28 ± 4.84, p < 0.01 |
| Patsatsi 201336, Greece | UST (45 mg at wks 0, 4 and then q12 weeks thereafter; 90 mg in patients with body weight > 100 kg) | Nonrandomized, open-label, uncontrolled, N = 27 | NAPSI at wks 0, 16, 28, 40 | Moderate-to-severe psoriasis (PASI ≥ 10) with nail involvement | % change in NAPSI from wk 0– wk 16: 45.3%, wk 0–wk 28: 87.6%, wk 0–wk 40: 98.0%; Friedman’s ANOVA, p < 0.0001; Mean NAPSI score at wk 0: 76.7, wk 16: 42.6, p < 0.001 c/w bl, wk 28: 10.3, p < 0.001 c/w bl, wk 40: 2.3, p < 0.001 c/w bl |
| Rich 201437, USA, Canada, Netherlands, Belgium | UST (45 mg SQ at wks 0, 4, 16, 28), vs UST (90 mg SQ at wks 0, 4, 16, 28), vs Pbo (crossover to UST 45 mg or 90 mg at wks 12, 16, 28). At wk 40, those with PASI75 re-randomized to continue maintenance dosing or receive Pbo | Randomized, double-blinded, Pbo-controlled, phase 3, N = 766 (545 with nail psoriasis) | NAPSI at wks 0, 12, 24 | Moderate-to-severe psoriasis | Mean % improvement in NAPSI score at wk 12: UST 45 mg: 26.7%, p < 0.001 c/w pbo, UST 90 mg: 24.9%, p = 0.001 c/w pbo; wk 24: UST 45 mg: 46.5%; UST 90 mg: 48.7% |
| Vitiello 201338, USA | UST (45 mg at wks 0, 4 and then q12 weeks thereafter; 90 mg used in 5 patients with body weight > 100 kg) | Case series, N = 13 | NAPSI at wks 0, 4, 12 | PsA for an average 16 years, failed ≥ 4 biologics | Mean NAPSI score at wk 0: 22.3, wk 4: 19.5, wk 12: 14.8; Mean percentage reduction in NAPSI from baseline to wk 14: 31.8% |
| Igarashi 201239, Japan | UST (45 mg SQ at wks 0, 4, then q12wks to wk 52), vs UST (90 mg SQ at wks 0, 4, then q12wks to wk 52), vs Pbo (crossover at wk 12 to either UST 45 mg or 90 mg SQ, wks 16, 28, 40, 52) | Randomized, double-blind, Pbo-controlled, phase 2/3, N = 158 | NAPSI at wks 0, 12, 64 | Moderate-to-severe plaque psoriasis ≥ 6 months, PASI ≥ 12, BSA ≥ 10% | Mean NAPSI score at baseline (if nail psoriasis present): UST 45 mg: 3.7 ± 1.8, UST 90 mg: 4.1 ± 2.0, Pbo: 4.6 ± 2.5; Mean % improvement in NAPSI score at wk 64: UST 45 mg: 56.6 ± 43.2%, UST 90 mg: 67.8 ± 37.5% |
| Rigopoulos 201140, Greece | UST (45 mg SQ if < 100 kg or 90 mg SQ if > 100 kg at wks 0, 4, 16 and 28) | Open-label, N = 27 | NAPSI at wks 0, 4, 16, 28, 40 | Plaque psoriasis with fingernail involvement, failed a systemic treatment | Mean NAPSI score at wk 0: 19.59 ± 7.92 (p value c/w bl), wk 4: 16.96 ± 6.99, p < 0.001, wk 16: 9.70 ± 4.47, p < 0.001, wk 28: 3.85 ± 3.03, p < 0.001, wk 40: 2.00 ± 2.34, p < 0.001 |
| Leonardi 201241, USA, Denmark | IXE SQ (10 mg) vs IXE (25 mg) vs IXE (75 mg) vs IXE (150 mg) vs Pbo, all at wks 0, 2, 4, 8, 12, 16 | Randomized, double-blind, pbo-controlled, phase 2, N = 142 | NAPSI at wks 0, 1, 2, 4, 6, 8, 12 | Chronic moderate-to-severe plaque psoriasis for ≥ 6 months, PASI ≥ 12, PGA ≥ 3, BSA ≥ 10% | Mean NAPSI score at baseline: IXE 10 mg: 41.9 ± 44.8, IXE 25 mg: 34.9 ± 37.7, IXE 75 mg: 45.0 ± 46.9, IXE 150 mg: 46.5 ± 51.7, Pbo: 35.0 ± 28.1; Mean % change in NAPSI score at wk 12: IXE 10 mg: 14.3 ± 97.8, NS c/w Pbo, IXE 25 mg: −24.0 ± 32.8, NS c/w Pbo, IXE 75 mg: −57.1 ± 36.7, p < 0.01 c/w Pbo, IXE 150 mg: −49.3 ± 35.9, p < 0.05 c/w Pbo, Pbo: 6.8 ± 41.1 |
Data in bold face are p values. btwn: between; PO: orally; qd: every day; qw: every week; SQ: subcutaneous; c/w: compared with; adalimumab (ADM); NAPSI: Nail Psoriasis Area Severity Index; narrow-band UVB (NB-UVB); MTX: methotrexate; Pbo: placebo; IFX: infliximab; ETN: etanercept; DMARD: disease modifying antirheumatic drugs; CZP: certolizumab pegol; PGA: physician global assessment; PASI: Psoriasis Area and Severity Index; BSA: body surface area; IXE: ixekizumab; UST: ustekinumab; eow: every other week; biw: biweekly; TNF: tumor necrosis factor; NR: not reported; bl: baseline.