Table 1.
Author | Year | Nonbiologic treatment | Design | Study population | Age (years) | Prior systemic treatment | Patients (n) | Treatment | Endpoint | Efficacy | Safety of combination | Comment |
---|---|---|---|---|---|---|---|---|---|---|---|---|
Kircik et al10 | 2008 | NBUVB/ETN | Open-label, uncontrolled, single arm | Moderate-to-severe plaque psoriasis | Mean, 40.6 | Oral: MTX (13), systemic steroids (13), ACT (12), CSA (4), tacrolimus (1) Biologic: alefacept (4) Other systemic: (9) | 86 | ETN 50 mg BIW + NBUVB (three sessions/week) | PASI-75 at week 12 | At week 12, 84.9% achieved PASI-75, 26% achieved PASI-100 | No SAEs reported | – |
De Simone et al9 | 2011 | NBUVB/ETN | Open-label, uncontrolled, single-arm | Moderate-to-severe plaque psoriasis | Mean, 48.3 | NR | 33 | ETN 50 mg QW + NBUVB (three sessions/week) for 8 weeks, then ETN monotherapy for 4 weeks | PASI-75 at week 12 | At week 12, 81.8% achieved PASI-75; 57.6% achieved PASI-90; and 24.2% achieved PASI-100. | No SAEs reported | – |
Wolf et al11 | 2009 | NBUVB/ETN | Open-label, controlled, half-body comparison study | Moderate-to-severe plaque psoriasis, not achieving PASI-75 after 6 weeks of ETN 50 mg BIW | Mean, 57 range, 48–66 | Light therapy: NBUVB (5) | 5 | ETN 50 mg BIW weeks 1–12 + half-body NBUVB, 3 sessions/week (weeks 6–12) | Half-body mean PASI score at week 12 | At week 12, mean PASI reduction from baseline was 89% (ETN + UVB) vs 68% (ETN; P<0.001) | No SAEs reported | – |
Calzavara-Pinton et al14 | 2013 | NBUVB/ETN | Randomized controlled intraindividual comparison study | Moderate-to-severe plaque psoriasis not achieving PASI-75 after NBUVB as first-line therapy and etanercept as second-line therapy | Mean, 40.4 range, 18–84 |
Biologic: etanercept alone Light therapy: NBUVB |
8 | ETN 50 mg BIW for 12 weeks, if patients did not achieve PASI-75 and were ineligible for conventional systemic therapy, NBUVB (3 sessions/week) was added (mean 14.6 ± 3.3 NBUVB sessions) (n=8) | PASI-75 at week 24 | At 24 weeks, 8/8 (100%) achieved PASI-75 | No SAEs reported | PASI-75 was achieved in 262 patients (81.4%) treated with NBUVB monotherapy. |
Park et al18 | 2012 | NBUVB/ETN | Pilot, randomized, “head-to-head” prospective comparison study | Psoriasis patients with a BMI > than 30 (average BMI 38.6) | Mean, 44 years range, 18–80 | NR | 13 | 1. ETN 50 mg BIW for 12 weeks, then ETN 50 mg QW for 12 weeks 2. ETN 50 mg BIW for 12 weeks, then ETN 50 mg QW + NBUVB (3 sessions/week) for 12 weeks (n=13) |
PASI-75 at week 24 | At week 24, 46.7% of subjects in the ETN monotherapy group, versus 53.3% in the ETN+ NBUVB group achieved PASI-75 | No SAEs reported | Limited by relatively small sample size, unable establish significance. A total of five patients did not complete the study. |
Lynde et al12 | 2012 | NBUVB/ETN | Randomized, open-label single-blinded study | Psoriatic patients not achieving PASI-90 after 12 weeks of ETN treatment | Mean, 43.9 range, 18–77 | Biologic: etanercept alone | 75 | ETN 50 mg QW monotherapy or in combination with NBUVB (3 sessions/week) for a period of 4 weeks (n=75) | PASI-90 at 24 weeks | At week 24, 16.2% of patients in the combination group and 15.8% of patients in the ETN monotherapy group achieved PASI-90. In those with high adherence to NBUVB, the PASI-90 at week 16 was 42.9% for etanercept with NBUVB, compared with 3.4% for etanercept monotherapy (P=0.018). | No SAEs reported | The combination of NBUVB/ETN enhanced the PASI response at weeks 16 and 24 in a small subset of patients with a high adherence to the NBUVB treatment. |
Gambichler et al13 | 2011 | NBUVB/ETN | Prospective, investigator-blinded, within-patient irradiated/nonirradiated, controlled study | Moderate-to-severe psoriasis | Mean, 42 | NR | 14 | ETN 25 mg BIW + NBUVB, 3 sessions/week for 6 weeks. One marker lesion covered as nonirradiated control for 6 weeks | M-PASI | After 6 weeks, the relative M-PASI reduction (mean ± SD) in ETN only sites (53.7±36.9%) was significantly lower than the reduction in ETN+ NBUVB-treated lesions (64±27.8%; P=0.011) | No SAEs reported | – |
Wolf et al15 | 2011 | NBUVB/ADA | Open-label, controlled, half-body comparison study | Moderate-to-severe plaque type psoriasis | Mean, 59 range, 49–67 | Oral: MTX (2), ACT (2), fumaric acid (1), PUVA (2) Biologic: ETN (3), ADA (1), alefacept (1) Light therapy: UVB broadband (1), NBUVB (1) | 4 | ADA 80 mg, week 0; 40 mg BIW + NBUVB to randomly selected body half (left or right, excluding the head), 3 sessions/week for 6 weeks | Half-body PASI at 6 weeks | Mean PASI reduction from baseline (start of ADA) of 86% on UV-irradiated body halves vs 53% on nonirradiated body halves | No SAEs reported | – |
Bagel16 | 2011 | NBUVB/ADA | Single-center, single-arm, open-label, prospective pilot study | Moderate-to-severe plaque type psoriasis | Mean, 39 range, 19–62 | No prior therapy | 20 | ADA 80 mg, week 0; 40 mg week 1; 40 mg every other week + NBUVB, 3 sessions/week | PASI-75 at week 12 | At week 12, 95% achieved PASI-75, 75% achieved PASI-90, 55% achieved PASI-100 | No SAEs reported | Limited by relatively small sample size, and an uncontrolled and unpowered single arm |
Wolf et al17 | 2012 | NBUVB/ustekinumab | Randomized, half-body comparison study | Moderate-to-severe plaque psoriasis | Mean, 58 range, 48–66 | Oral: MTX (5), ACT (5), fumaric acid (6), Biologic: alefacept (1) efalizumab (2) ETN (8) ADA (3) infliximab (2) Light therapy: UVB broadband and/or NBUVB therapy (8), PUVA (10) | 10 | Ustekinumab (standard dosage) at weeks 0 and 4 + NBUVB randomly selected body half (left or right, excluding the head), 3 sessions/week for 6 weeks. (n=9) | Half-body PASI at 6 weeks | At week 6, 7/9 patients (78%) in the UV-irradiated body half arm and 1/9 patients (11%) in the nonirradiated body half arm achieved PASI-75 (P=0.007). | 1/10 (10.0%) of patients reported SAEs in the UV-irradiated body. Circumscribed herpetic eruption (1), patient was discontinued from study. | – |
Note: ‘–’ indicates no data.
Abbreviations: ACT, acitretin or oral retinoid; ADA, adalimumab; BIW, twice weekly; BMI, body mass index; CSA, cyclosporine; ETN, etanercept; MTX, methotrexate; n, number of patients; NBUVB, narrow band ultraviolet B; NR, not reported; PASI, Psoriasis Area Severity Index; PUVA, psoralen + ultraviolet A; QW, every week; SAE, serious adverse event; UV, ultraviolet; UVB, ultraviolet B.