Table 4.
Hyperkeratotic PP, pustular PP, and/or PPP, efficacy and safety of biologic agents
| Reference, type of study | Number of subjects | Treatment | Treatment duration | Outcome | Safety/comments |
|---|---|---|---|---|---|
| Adalimumab | |||||
| Richetta 2012 [19], open label study | 11 (hyperkeratotic or pustular PP; variant not reported) | Adalimumab (40 mg q 2 weeks) | 12 weeks |
PGA improvement 54.5%, mean PGA: 1.09, PGA 0 36.1%; DLQI improvement: 72.3%, mean DLQI: 7.45, ≥ 50% DLQI improvement 45.5% |
No AEs reported |
| Anakinra | |||||
| Tauber 2014 [52], case report |
(1) pustular PP, (2) hyperkeratotic PP |
Anakinra (100 mg SC) |
(1) 3 months; (2) 1 month |
(1) Partial response to PPASI 20.7 and DLQI 13 at 2 weeks but relapsed at 3 months, stopped due to lack of efficacy/recurrence (2) Partial response to PPASI 13.5 at 1 mo, stopped due to fever without cause |
(1) relapse of pustular lesions; (2) AE of fever |
| Etanercept | |||||
| Spuls 2003 [26], Case series | 1 (etanercept) and 1 (infliximab) (subset of 26 patients with PP; hyperkeratotic or pustular variant not reported) |
(1) Etanercept; (2) infliximab |
Not described |
(1) Complete resolution (2) Complete resolution |
No AEs reported |
| Infliximab | |||||
| Di Lernia 2010 [34], Case series |
3 (hyperkeratotic PP), 1 (PPP) |
Infliximab 5 mg/kg IV at weesk 0, 2, 6 and every 8 weeks thereafter | 10–16 months | At 16 weeks, (1) PPPAS- 100; (2) and (3) PPPASI-75; (4) PPPASI-50 | 1 SAE: infusion-related urticarial reaction in patient 2 at week 46 leading to discontinuation |
| Ustekinumab | |||||
| Bissonnette 2013 [11], Double-blind randomized placebo-controlled trial |
10 (pustular PP), 5 (PPP) |
1:1 ustekinumab 45 mg SC at weeks 0, 4, and 16 vs. placebo at weeks 0 and 4, then ustekinumab 45 mg SC at weeks 16 and 20 | 28 weeks (primary endpoint at week 16) | At week 16, 10% of subjects with pustular PP achieved PPPASI-50 vs. 20% in placebo group (p = 1.00); 20% of subjects with PPP achieved PPPASI-50 vs. 37.5% in placebo group (p = 1.00) | No SAEs reported; 1 leg cellulitis (possibly related) and 1 pneumonia (unrelated) |
| Au 2013 [10], Open-label prospective trial |
10 (hyperkeratotic PP), 10 (pustular PP) |
Ustekinumab 45 mg for body weight < 100 kg, 90 mg for body weight ≥ 100 kg SC at weeks 0, 4, 16 | 16 weeks | At week 16, 35% (7/20) achieved clinical clearance, 60% (12) Palm-Sole PGA improved ≥ 2 points | No related SAEs reported; 67% receiving 90 mg achieved clinical clearance vs. 9% of those on 45 mg |
| Bertelsen 2014 [54], Case series |
6 (pustular PP), 5 (PPP) |
Ustekinumab 45 mg SC at weeks 0, 4, and every 12 weeks thereafter | Up to 44 months |
Pustular PP: 1 Complete resolution (1), partial response (3), no response (1), progression (1); PPP: Partial response (3), no response (1), progression (1) |
Flu-like symptoms, headache, fatigue (1); no difference reported in response between patients with palmoplantar pustular psoriasis and palmoplantar pustulosis |
AE Adverse event, BSA body surface area, DLQI Dermatology Life Quality Index, F female, hfPGA Physician Global Assessment of the hand and foot, HTN hypertension, IGA Investigator Global Assessment, IM intramuscular, IV intravenous, M male, m-PPPASI modified Palmoplantar Pustulosis Area and Severity Index, PASI Psoriasis Area and Severity Index, PGA Physician Global Assessment, PO orally, PP palmoplantar psoriasis, PPIGA palmoplantar psoriasis Investigator Global Assessment, PPP palmoplantar pustulosis, PsA psoriatic arthritis, PUVA psoralen + ultraviolet A, q every, RCT randomized controlled trial, SAE serious adverse event, SC subcutaneous, URI upper respiratory infection UVA ultraviolet A, UVB ultraviolet B
aPrimary endpoint of study