Photodynamic Therapy

Photodynamic therapy is approved by the FDA for the treatment of actinic keratoses (AK), which are precancerous skin growths caused by sun-damaged cells in the epidermis (the skin's outermost layer).

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"We think of these as precursors to skin cancer," says Dr. Christensen. "The risk of any one of them going on to become cancer is very low, but people usually have multiple actinic keratoses on places like the forehead, cheeks or bare scalp. If they have a dozen growths in a given area, then there is a significant risk of skin cancer in that area."

The growths, which are red, pink or flesh-colored and scaly or crusty, don't usually hurt or itch, but they can be bothersome to look at and feel, so patients often want them removed. Photodynamic therapy is more practical and effective than other treatments for AK (such as liquid nitrogen) when there are multiple lesions.

Treating an affected region of the skin is called "field therapy," Dr. Christensen says. "Instead of treating 20 individual spots with liquid nitrogen or excision," he says, "which can both be quite painful and leave scars, field therapy allows us to get all the spots at once and also treat spots below the skin's surface that aren't yet visible to the naked eye."

Photodynamic therapy (PDT) offers several unique benefits for patients seeking treatment for actinic keratoses and other skin conditions:

• Minimal Invasiveness: PDT does not require surgical incision, reducing the risk of infection and scarring.
• Targeted Treatment: The therapy specifically targets abnormal cells without significantly affecting surrounding healthy tissues.
• Quick Recovery: Patients typically experience shorter recovery times compared to surgical options, allowing them to resume normal activities sooner.
• Cosmetic Outcomes: PDT generally results in better cosmetic outcomes with fewer visible marks or scars post-treatment.
• Combination Potential: PDT can be combined with other treatments to enhance overall effectiveness for various skin conditions.

Thirty-two studies involving a total of 2120 psoriasis patients were included in this network meta-analysis. Overall, no significant difference was reported with respect to withdrawal due to AEs or incidence of erythema. The relatively safest strategy was combined adjuvant therapy with PUVA (cPUVA), especially PUVA combined with calcium/vitamin D derivatives (RR 0.98, 95% CI [0.30–3.17], SUCRA = 80.8%). Both cPUVA (RR 1.39, 95% CI [1.00– 1.94]) and combined adjuvant therapy with UVB (cUVB) (RR 1.27, 95% CI [1.03–1.57]) showed a superior effect than the monotherapy of UVA or UVB, respectively. PUVA combined with vitamin D and its derivatives (PAVD) ranked highest concerning clinical effect and safety (clusterank value = 7393.2).

In this study, we performed an NMA collecting direct and indirect evidence from several RCTs simultaneously [9]. Specifically, the achievement of PASI 75 response (75% or more reduction in PASI score from baseline) in the short-term period of treatment was chosen to measure its efficacy since it is indicative of both severities and involved area of psoriatic lesions, as well as it is evaluated and described in most reported trials and reviews [10, 11]. This study was aimed to compare the efficacy and tolerability of UV-based therapies, used as monotherapy or in combination with various drugs and remedies, including systematic treatments, skin lubricants, vitamins and vitamin derivatives, for the treatment of moderate-to-severe psoriasis. We also considered the absolute effects of therapies to provide information supporting clinical decision-making and care planning.

Although systemic and biological treatments are strongly recommended for severe and diffuse skin diseases, these medications can determine systemic side effects and immunosuppression. Based on the evidence from National Psoriasis Foundation, UVB phototherapy (broadband [BB] or narrow-band [NB]) is suggested for patients suffering from moderate-to-severe psoriasis before adopting treatments with systemic and biologic agents. Besides, PUVA is indicated for patients with poor NB-UVB control and high psoriasis area and severity index (PASI) scores [5]. Among phototherapy regimens for psoriasis, broadband UVB (BB-UVB) has the longest history and narrowband UVB (NB-UVB) represents the first-line phototherapy treatment, also in combination with other regimens [6]. These UV-based phototherapies, along with their combination with other treatments, are thought to be effective treatments for many psoriasis patients, leading to an urgent demand for comparative studies of efficacy referring to clinical decision making. A meta-analysis published in 2013 comparing the efficacy of localized phototherapies showed that topical PUVA treatment is more effective than non-laser targeted UVB phototherapy [7]. Almutawa et al. summarized characteristics of UV-based therapies, indicating that PUVA monotherapy showed higher effectiveness than UVB-based therapy in determining complete skin clearance of patients with moderate-to-severe plaque-type psoriasis [8]. Since then, there have been several randomized controlled trials (RCTs) on demonstrating and comparing the efficacy, safety or tolerability of monotherapies and UV-based combinatorial therapies. However, no comprehensive studies evaluating relative UV efficacy and tolerability have been carried out so far. Although several head-to-head trials exist, RCTs have not considered all possible pairwise combinations of UV-based therapies with agents, or simultaneous direct comparisons of multiple treatments.

Psoriasis is known as a common, immune-related, chronic inflammatory skin disorder and the estimated prevalence was ranging from 0.51 to 11.4% in worldwide adults [1]. Plaque psoriasis is the most common type, and most psoriasis patients suffering from the mild-to-moderate disease can be treated with topical treatments, whereas severe cases require additional therapeutic options [2]. Systemic therapies, including oral retinoids, as well as biologics or phototherapy are used for the long-term treatment of psoriasis [3]. Ultraviolet (UV)-based phototherapy with UVB or psoralen UVA (PUVA) is also a well-established and generally effective treatment for chronic plaque psoriasis employing UV light with or without photosensitizers [4].

Inconsistencies were assessed with global inconsistency tests and node-split tests, and only if both results reported no significant inconsistency (p > .05), the consistency model was adopted. If inconsistency was reported in any network, a sensitivity analysis was used to identify the source of inconsistency and to exclude studies from the network. Publication biases for each network were evaluated by funnel plots, and for networks whose funnel plots showed possible asymmetry, the presence of publication bias was assessed by the egger's test. The relative efficacy and safety of different phototherapy strategies were ranked using surface under the cumulative ranking (SUCRA) probabilities [15] and cluster-ranking plots were constructed to determine the optimal choice for multiple outcome indicators. Further subgroup analysis was conducted for exploring the optimal combination of drugs. Data relative to four subgroups of drugs, including vitamin A and its derivatives, vitamin D and its derivatives, skin lubricants, and system treatments, were obtained.

Considering that the differences between the baseline values of each included study may reduce the reliability of the results and conclusions, the changes from the baseline value of PASI (PASI improvement) at the last follow-up were calculated (mean ± SD) and used to reconfirm the findings from PASI 75 or above. For studies not reporting PASI improvement, the correlation coefficient method recommended by Cochrane Handbook [13] was used to calculate the changes.

The primary efficacy endpoints were the percentage of patients achieving PASI 75 or a PASI response greater than PASI 75 if the latter was not available. As for the other assessment standards, we only included trials reporting the complete clearance of the disease or nearly clearance (90% improvement from the baseline). Those trials that reported PASI 75, PASI 90 or clearance were grouped into PASI 75 and above.

For studies with insufficient data, we contacted the corresponding authors. We chose to contact the corresponding authors when relatively to data of studies were presented as figures and not as numeric data in the manuscript text or tables. If no response was received, two current authors (Y.L. and Z.C.) independently extrapolated data from the graphs/figures. If that was not possible the study was excluded. All disagreements were resolved according to the discussion with the third author (J.G.).

The following studies were used in our NMA: 1. studies analysing psoriasis patients undergoing phototherapy; 2. studies comparing two or more different treatment strategies; 3. studies describing RCTs with prospective parallel-group design; 4. studies reporting at least one of the following outcomes: PASI, withdrawal due to adverse events (AEs), and incidence of erythema. On the contrary, we excluded: 1. low-quality studies according to the corresponding quality assessment tools; 2. dose-escalation studies made using only one treatment strategy; 3. animal studies, in vitro biomechanical studies, cadaver studies, case-control studies, reviews, systematic reviews and meta-analyses, conference abstracts, letters and analyses not comprising original data.

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Two authors (Y.L. and Z.C.) independently and systematically searched the following queries in PubMed, Cochrane Library, Scopus and Embase, from January 1980 to January 2021: "psoriasis" OR "psoriatic" AND "light therapy" OR "phototherapy" and "ultraviolet radiation A" OR "UVA" OR "ultraviolet radiation A with psoralen" OR "PUVA" OR "ultraviolet radiation B" OR "UVB" OR "excimer" OR "TL-01" OR "PUVA" AND "combination" OR "UVB" AND "combination". Additional potentially eligible studies were screened by further reviewing reference lists of identified articles. There was no restriction on the language of publication.

Fourteen trials with 844 patients could be included in this network. Although the application of the egger's test revealed no concern (p = .668), the publication bias and small-study effect could likely represent critical issues. Again, the consistency model was adopted. PAVD- and UBSL-treated patients showed a better response as compared to patients undergone the other treatments. According to SUCRA, PAVD and UBSL ranked highest (SUCRA = 98.3 and 88.9%, respectively), whereas UVB ranked lowest (SUCRA = 18.6%).

A total of 32 trials with 2120 patients were involved in this network. Also for this analysis, no significant inconsistency was found. PAVD and UBST groups showed a better response, in terms of achievement of a PASI 75 and above response (SUCRA = 97.4 and 70.8%), and, similarly to what was observed for PASI 75 response network, UVB ranked lowest (SUCRA = 18.2%). PAVD treatment determined a better response than PAVA (RR 1.69, 95% CI [1.05–2.72]), UBSL (RR 1.72, 95% CI [1.04–2.84]), cAB (RR 1.78, 95% CI [1.04–3.03]), PUVA (RR 1.86, 95% CI [1.22–2.84]) and UVB (RR 1.88, 95% CI [1.21–2.92]) therapies. UBST was also better than UVB treatment (RR 1.26, 95% CI [1.01–1.57]).

A total of 20 trials with 1500 patients were included in this network. The application of the consistency model did not reveal any inconsistency. PAVD treatment was potentially the best therapeutical strategy according to SUCRA (SUCRA = 91.5%), followed by UBST (SUCRA = 83.0%) and UBSL (SUCRA = 54.5%) therapies. UVB was the less effective treatment (SUCRA = 24.8%). In addition, PAVD was sìnificantly better than both PUVA (RR 1.86, 95% CI [1.15–3.01]) and UVB (RR 1.87, 95% CI [1.09–3.19]) treatments, and UBST was more efficacious than UVB (RR 1.58, 95% CI [1.08–2.31]).

For this network, we only analysed data on 844 patients in 14 trials, so these results should be explained with caution. No significant inconsistency was detected by using the consistency model. Although the funnel plot of this network showed dubious asymmetry, egger's tests did not report any significant publication bias or small-study effect (p = .661). From these analyses, the cPUVA group resulted to respond significantly better than PUVA (SMD 2.31, 95% CI [0.48–4.13]) or UVB (SMD 2.17, 95% CI [0.15–4.18]) groups, and the cUVB-treated group achieved better PASI responses than UVB-treated group (SMD 1.22, 95% CI [0.05–2.39]). According to SUCRA, cPUVA and cUVB ranked highest in efficacy (SUCRA = 89.5 and 67.4%, respectively), whereas PUVA was the lowest-ranked treatment (SUCRA = 19.4%).

A total of 19 trials with 1476 patients were included in this network. No inconsistency was detected after the application of the consistency model. Based on the SUCRA values, the cPUVA group obtained the highest PASI 75 response (SUCRA = 86.0%), followed by cUVB (SUCRA = 79.0%) and UVB (SUCRA = 32.0%), whereas the lowest PASI 75 was achieved following CAB treatment (SUCRA = 26.1%). The cPUVA group was numerically higher than PUVA group (RR 1.39, 95% CI [1.00–1.94]), whereas the cUVB group outnumbered the UVB group (RR 1.27, 95% CI [1.03–1.57]).

Thirty-two studies were included following the systematic screening of the Literature ( Figure S1 ) [16–47]. In the main network analysis, five different phototherapy strategies were identified and analysed: PUVA, UVB, combined adjuvant therapy with PUVA (cPUVA), combined adjuvant therapy with UVB (cUVB) and the combination of PUVA with UVB (cAB). According to the category and activity mechanism of the adjuvant treatment, nine subgroups were identified and analysed: PUVA, UVB, PAVA (PUVA combined with vitamin A and its derivatives), PAVD (PUVA combined with vitamin D and its derivatives), UBVA (UVB combined with vitamin A and its derivatives), UBVD (UVB combined with vitamin D and its derivatives), UBST (UVB combined with systematic treatments), UBSL (UVB combined with skin lubricants) and cAB. The network plot of the main network analysis and subgroup analysis are shown in .