Table 2.

Overview of dedicated, prospective NP studies of currently approved treatments for PsO and/or PsA.

Drug(s)Study, YearPatient PopulationNail PsO Outcome Measure(s)Key Nail PsO Efficacy Results
      Nonbíologícs
Acitretin
      Acitretin (0.2–0.3 mg/kg QD for 6 months)Tosti, 200981M/S isolated fingernail PsO (n = 36)Primary: NAPSI (0–80), target mNAPSI (0–13)Change from BL to 6 months, mean %
NAPSI−41
Modified target NAPSI−50
CsA
      CsA (3.5 mg/kg/d) ± topical calcipotriol BIDFeliciani, 200482S PsO with nail PsO (n = 54)Primary: 3-level improvement score (+, ++, +++)Patients with improved clinical appearance of nails, %
CsACsA + topical
Month 34779
      CsA (3 mg/kg BID)Abe, 201183Pretreated for nail PsO (n = 32)Primary: “Nail PASI” (unclear)Complete resolution in 25%; significant improvement in 50%
MTX
      MTX (15 mg QW, initial dose) vs CsA (5 mg/kg QD)Gümüçel, 201184PsO or PsA and nail PsO (n = 37)Primary: NAPSI (0–80)NAPSI change from BL to 24 weeks (mean %): MTX (−43.3), CsA (−37.2)
      MTX (15–25 mg QW)Krajewska-Wlodarczyk, 20186Nail PsO, DIP enthesitis, MTX-naïve (n = 319 nails in 32 pts)Primary: US imaging of nail plate, nail bed, and nail matrix Secondary: mNAPSI (0–130)ThicknessBL, mean (SD)6 months, mean (SD)P
Nail platePsA pts0.74 (0.05)0.73 (0.04)0.004
PsO pts0.75 (0.04)0.74 (0.05)0.002
Nail bedPsA pts2.02 (0.03)2.00 (0.05)< 0.001
PsO pts2.04 (0.03)2.01 (0.06)< 0.001
Nail matrixPsA pts1.93 (0.02)1.93 (0.03)< 0.001
PsO pts1.93 (0.01)1.93 (0.01)< 0.001
TRI
      TRI acetonide injection (10 mg/mL) into nail bed/matrix (4 sites, repeated at 2 months if poor response)Saleem, 200885Nail PsO (n = 35, 100 nails)Primary: 0–3 severity score for various nail pathologiesResponse at 6 months (no. nails)
NonePartialComplete
Pitting302615
Onycholysis2287
Subungual hyperkeratosis171030
Ridging141628
Thickening5103
Discoloration5020
      TRI acetonide (intramatricial needle-free injection)Nantel-Battista, 201486Nail PsO (n = 17)Primary: Target NAPSI (0–8)Target NAPSI, mean
BL NAPSI6.5
Week 16 NAPSI2.8
Week 16 reduction from BL46.25%
      TRI (intralesional injection)Boontaveeyuwat, 201987Nail PsO (n = 48 nails)Primary: Target NAPSI for each affected nail (0–32)Temporary reduction in target NAPSI over 1–4 months
      Intramatricial injection of: TRI acetonide (10 mg/mL) vs MTX (25 mg/mL) vs CsA (50 mg/mL)Mittal, 20186717 pts with 90 affected fingernailsPrimary: NAPSI (0–80)NAPSI75, mean %
TRIMTXCsA
Week 24505033
Biologies
      TNFi: ADA
           ADA (80 mg at Week 0, then 40 mg Q2W)Rigopoulos, 201088S PsO (n = 7) or PsA (n = 14), with nail PsOPrimary: NAPSI fingers (0–80), NAPSI toes (0–80)NAPSI, mean (SD)
PsO onlyPsA
FingersToesFingersToes
BL10.6 (1.2)14.7 (2.5)23.9 (2.0)29.3 (2.9)
Week 125.6 (0.8)9.6 (2.2)12.9 (1.1)19.2 (2.1)
Week 241.6 (0.2)4.1 (1.6)3.2 (0.3)10.0 (1.4)
           ADA (RWD)Khobzey, 201789M/S PsO ± PsA and NAPSI ≥ 10 (n = 157)Primary (RWD): NAPSI (0–160) 4 visits over ≤ 12 monthsVisit 1–4: -81.6NAPSI change from BL, mean % NAPSI50: 90.4 at Visit 4NAPSI100: 40.0 at Visit
           ADA (40 mg Q2W) vs PBOElewski, 201 880M/S PsO plus ≥1 fingernail (n = 217)Primary: mNAPSI (0–130), target mNAPSI (0–13). Secondary: NAPSI (0–80), nail PsO pain, NPPFS, B-SNIPI50, f-PGAmNAPSI75 Week 26ADA, mean % 46.6PBO, mean % 3.4P < 0.001
TNFi: ETN
           ETN (50 mg BIW for 12 weeks then QW for 12 weeks; or QW 24 weeks)Ortonne, 201390M/S PsO, failed systemic for nail PsO (n = 69)Primary: Target NAPSI (excluding thumb, 0–8). Secondary: NAPSI (excluding thumb, 0–64)Target NAPSI change from BL, mean
QWBIW/QW
Week 24−4.3−4.4
TNFi: IFX
           IFX (5 mg/kg IV at 0, 2, 6, 14, and 22 weeks)Bianchi, 200591Pre-treated PsO or PsA NAPSI > 14 (n = 25)Primary: NAPSI (0–80)Week 14: 100% NAPSI50
Week 22: 100% NAPSI100
           IFX (infusion of 5 mg/kg at Weeks 0, 2, and 6, then Q8W)Rigopoulos, 200892PsO/PsA with nail PsO starting IFX (n = 18)Primary: NAPSI (0–80)NAPSI, mean
BL55.8
Week 1429.8
Week 383.3
IL-12/23 inhibitor: UST
           UST (45 mg at Weeks 0 and 4, then Q12W)Patsatsi, 201393M/S PsO, nail PsO (n = 27)Primary: NAPSI (0–160)NAPSI, median (range)
BL73.0 (12.0–151.0)
Week 1637.0 (7.0–92.0)
Week 289.0 (0.0–32.0)
Week 400.0 (0.0–12.0)
           UST (45 mg/90 mg [for BW </> 100 kg] at Weeks 0 and 4, then Q12W)Rigopoulos, 201194PsO with fingernail PsO (n = 27)Primary: NAPSI (0–80)NAPSI, mean (SD)
BL19.6 (7.9)
Week 169.7 (4.5)
IL-17A inhibitors: SEC
           SEC (300 mg or 150 mg Q4W) vs PBOReich, 201876 (NCT01807520: TRANSFIGURE)M/S PsO, M/S nail PsO (n = 198)Primary: NAPSI (0–80). Secondary: target toenail NAPSI (0–8), NAPPANAPSI change from BL, mean %
FingernailsTarget toenail
SECSECPBOSECSECPBO
300 mg150 mg300 mg150 mg
Week 16−45.3−37.9−10.8−15.3−15.8−9.7
Week 32−63.2−52.6−35.2−37.6
Week 132−70.5−52.9
Head-to-head studies
Biologics
      ADA (80 mg at Week 0, 40 mg at Week 1, then Q2W) vs ETN (50 mg BIW for 12 weeks then 25 mg BIW for 12 weeks) vs IFX (infusion of 5 mg/kg at Weeks 0, 2, and 6, then Q8W)Saraceno, 201375Nail PsO (n = 60)Primary: NAPSI (0–80)NAPSI, mean (SD)
ADAETNIFX
BL33.1 (14.9)34.8 (12.4)33.3 (9.8)
Week 1421.0 (8.9)23.6 (10.4)14.9 (4.2)
Week 2411.4 (4.6)10.6 (5.3)3.1 (3.3)
  • ADA: adalimumab; BL: baseline; B-SNIPI50: 50% improvement in Brigham Scalp Nail Inverse Palmoplantar Psoriasis Composite Index; BW: bodyweight; CsA: cyclosporine A; DIP: distal interphalangeal; ETN: etanercept; f-PGA: fingernail physician global assessment; IFX: infliximab; IL: interleukin; IV: intravenous; MTX: methotrexate; mNAPSI: modified NAPSI; M/S: moderate to severe; NAPPA: Nail Assessment in Psoriasis and Psoriatic Arthritis; NAPSI: Nail Psoriasis Severity Index; NAPSI50/75/100: 50/75/100% reduction from BL in NAPSI; N-NAIL: Nijmegen-Nail Psoriasis Activity Index Tool; NPPFS: Nail Psoriasis Physical Functioning Severity; PASI: Psoriasis Area and Severity Index; PBO: placebo; PsA: psoriatic arthritis; PsO: psoriasis; pts: patients; RWD: real-world data; S: severe; SEC: secukinumab; TNFi: tumor necrosis factor inhibitor; TRI: triamcinolone; US: ultrasound; UST: ustekinumab.