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Ophthalmological study of patients undergoing long-term PUVA therapy
Abstract
In the present study 46 patients with severe psoriasis maintained on long-term PUVA therapy have been followed up to 6 1/2 years after the initiation of treatment. Repeated ophthalmological examinations were performed in order to detect any early sign of lens changes. No ocular side effects attributed to the photochemotherapy were revealed during this period. Continued use of appropriate eye shielding is recommended and also routines to remind patients to actually wear their protective glasses.
... References published between 1980 and December 2010 in the PubMed, Embase and Cochrane databases, in English and French, were reviewed using the key words 'Psoriasis' AND'phototherapy' OR 'ultraviolet therapy' OR 'UVA' OR 'UVB' OR 'PUVA' OR 'photochemotherapy' AND 'ocular' OR 'cataract' OR 'eye' OR 'lens' Of the 30 references found, 12 were eliminated by reading the title or abstract (eight did not concern PUVA, two did not concern psoriasis, one was a case report, one was a review). and five after reading the article We finally selected 13 studies: seven were prospective [5][6][7][8][9][10][11] and six were retrospective. [12][13][14][15][16][17] All studies concerned exclusively PUVA therapy. ...
... The four other prospective studies, [8][9][10][11] summarized in Table 1, contained few numerical data, and failed to find any increased risk of cataract following PUVA therapy. ...
Psoralen photochemotherapy (PUVA) is a combination of orally administered psoralen (8-methoxypsoralen or 8-MOP) and long wave ultraviolet-A radiation (UVA). It is one of the most effective treatments for moderate to severe psoriasis. Long-term use of PUVA has been shown to increase the risk of skin cancer especially squamous cell carcinoma, 1 and skin ageing. 2 In experimental studies, exposure of unprotected eyes to PUVA in rodents accelerates the development of ocular lens opacities. 3,4 Whereas UVA light penetrates both the cornea and the aqueous humour, after oral administration, 8-MOP psoralen also reaches the lenses. Narrow-band (312 ± 2 nm) UVB radiation from TL01 lamps is an effective phototherapy modality developed more recently for psoriasis. UVB also reaches the lens and might also theoretically induce ocular damage following long-term exposure. This theoretical risk of cataract induced by phototherapy has justified the use of eye protection during PUVA or NB-UVB sessions. In addition the use of UV-blocking glasses during daytime is recommended in patients the days they are taking psoralen for their PUVA sessions. Human studies on the long-term adverse ocular effects of both phototherapy regimens for psoriasis are rare and an increasing risk of ocular damage has not yet been clearly established. We performed a systematic review of the literature to assess the respective risk of ocular damage, especially cataract, in psoriasis patients treated with PUVA and NB-UVB therapy.
... Long term side effects have recently been discussed in some reports with observations including clinical and histopathological findings from several thera peutic centres (I, 2, 3, 4, 5, 6, 7. JO, 11. 13, 15,16,21). Special reports have been directed to pos sible influence on the melanocyte, pigmentation and nevocellular nevi, but also passible ophthalmo logical hazards (1, 3, 8,9,12,14,17,20). The matter of greatest concern has been the possible induction of premalignant or malignam changes in patients on long-term therapy (3, 5,6,7,10,11,13,15,16). ...
... A thorough ophthalmological study was also conducted in some of the patients, but the results are rcported else "'here (14). ...
A thorough clinical and microscopical investigation was conducted in patients with severe longstanding psoriasis maintained on long-term photochemotherapy with PUVA. 250 patients were reinvestigated after PUVA therapy for up to 7 years, 49% for 5 to 7 years. No serious side effects were observed. Occasional peculiar hyperkeratoses of a bowenoid type were seen in 3 patients (1.2%) and solitary lesions at actinic keratoses in 5 patients (2%). No occurrence of squamous cell carcinoma nor basal cell carcinoma was detected. Lentiginosis of varying degree was fairly common and seen in 33% and a very profuse disseminated lentiginosis in 4%. Six patients (2.4%) developed isolated, clinically dark and irregular lentiginous spots which on biopsy showed microscopically an aberrant morphology and were therefore classified as atypical lentigines. All of them had earlier been subjected to extensive courses of UVB treatment and 3 of them had history of earlier arsenic therapy. No malignant transformation was seen but those were for reasons of safety referred to the risk group category and may prove to be at particular risk on future PUVA therapy.
Eye involvement in psoriasis is little known to many dermatologists, although psoriasis has been acknowledged as a systemic disease for decades. The ophthalmic complications of psoriasis are numerous and can affect almost any part of the eye. The most common ocular changes in patients with psoriasis, including blepharitis, conjunctivitis, keratitis, iridocyclitis, UV-induced cataracts, uveitis, and birdshot chorioretinitis, have been described in the literature. Recognition of the ocular complications of psoriasis is of significant clinical importance, because various pathogenic mechanisms may contribute to the development of ocular manifestations, including direct eye involvement with psoriatic plaques, psoriasis-related immune-mediated inflammatory processes, and complications of psoriasis treatments.
Ultraviolet radiation-based therapies of vitiligo are the most potent options for its treatment. This chapter shall provide detailed information about the role and application of phototherapeutic regimens. Initially, the disease will be defined and compared to other conditions in the differential diagnosis. The main portion of this chapter will concentrate on ultraviolet phototherapy and photochemotherapy. Adjunctive and combined therapeutic modalities are discussed, as well as alternative treatment options.
Dieses Kapitel beschäftigt sich mit der Anwendung von Photochemotherapie und Phototherapie bei Vitiligo. Zunächst wird die Krankheit definiert und werden Differentialdiagnosen und assoziierte Phänomene beschrieben. Allgemeine therapeutische Maßnahmen und Alternativen zu phototherapeutischen Verfahren folgen. Den Hauptteil bildet die Beschreibung der praktischen Durchführung und Wirkung der Bestrahlungsbehandlung mit oder ohne Photosensibilisator sowie von kombinierten Therapieformen.
Vitamin A is important in maintaining general growth, regulating proliferation, differentiation of epithelial tissues, and in maintaining visual and reproductive functions. Chronic hypervitaminosis A is associated with skeletal abnormalities, resulting from accelerated bone and cartilage resorption and new bone formation. Bone abnormalities associated with chronic hypervitaminosis is tabulated. Synthetic derivatives of vitamin A (retinoids) are currently being tested in diseases treated by a variety of specialists. Skeletal abnormalities caused by hypervitaminosis A may be reversible and these abnormilities are also tabulated with their treatment. Although there can be no doubt that etretinate can and will cause skeletal abnormalities in a number of patients, the overall risk of skeletal toxicity in patients treated with the drug over prolonged periods remains undecided. Contact allergy to drugs and cosmetic allergy is presented in a tabular form.
The therapeutic benefit of ultraviolet light in certain diseases, notably psoriasis, with and without the addition of photosensitizing drugs, has been recognized for many years. The combination of a photoactive chemical and light defines the term photochemotherapy. The wavelength of light used is determined by the activation spectrum of the chemical agent. The interaction of the light and chemical produces a synergistic effect. The clinical, pharmacologic, and toxic effects of the Goeckerman regimen, PUVA therapy, chemoporphyrin therapy, and the treatment of hyperbilirubinemia are reviewed. © 1985 Informa UK Ltd All rights reserved: reproduction in whole or part not permitted.
This 5-year prospective study of ophthalmologic findings in 1299 patients treated with oral 8-methoxypsoralen photochemotherapy (PUVA) for psoriasis failed to demonstrate a significant dose-dependent increase in the risk of developing symptomatic cataracts. These patients were instructed to wear UVA-blocking eye-glasses when exposed to sunlight and during treatment for a 12-h period beginning from the time of 8-methoxypsoralen ingestion. However, we did observe a small increase in the risk for development of nuclear sclerosis and posterior subcapsular opacities among patients who received at least 100 PUVA treatments, compared to patients with fewer than 100 treatments (relative risk = 2.3 and 3.0, respectively; p < .05 both comparisons). We compared our results to those of a large, population-based study and found, after adjusting for differences in methods, that the prevalence of cataracts in our study patients, aged 52–75 years, was not significantly different. Since the latency period for development of symptomatic ocular abnormalities may be longer than 5 years, continued surveillance of our cohort and continued use of appropriate ocular protection by all patients treated with PUVA is indicated.
› Vitiligo, an autoimmune disorder that targets melanocytes, is difficult to treat.
› At present, the best monotherapeutic option is narrowband ultraviolet B phototherapy.
› Most of the regimens that show reasonable efficacy in the treatment of vitiligo are either phototherapeutic regimens or combination therapies that include phototherapy.
The numerous side effects of drugs on the eye have been well documented in detailed monographs.47b,54,59 It is the purpose of this chapter to give a brief overview of selected morphologic changes to various ocular tissues, many of which have been partially considered in previous chapters (see Chapters 6–15).24
In some animal species, exposure of the ocular lens to 8-methoxypsoralen (8-MOP) and ultraviolet-A radiation (PUVA) induces lens opacities. Case reports have suggested that PUVA therapy in humans may be associated with an increased risk of ocular lens abnormalities. To examine this risk, we compared the results of the initial and final examinations, which were performed on an average of 10 years apart in 1,235 individuals enrolled in the PUVA Follow-up Study.
After adjustment for age and sex, there was no significant relation between the risk of developing an ocular lens abnormality or cataract and the level of exposure to PUVA. A higher incidence of cataract was noted, however, in the PUVA cohort compared to a large population-based study. In addition, rates of cataract extraction were significantly higher among male members of the PUVA study compared to enrollees in the Physician Health Study.
Overall, our data strongly argue against a dose-dependent increase in the risk of cataract or other lens abnormality in association with PUVA therapy in a cohort most of whose members we believe usually used recommended eye protection. Our data do not explain the higher incidence and prevalence of ocular lens pathology in our cohort compared to groups without psoriasis. These differences could reflect differences in criteria for defining these abnormalities, other exposures, or PUVA.
An epidemiologic investigation on the prevalence of cataract in glass workers is presented. The study includes 209 workers over 50 years of age exposed to infrared (IR) radiation in the Swedish manual glass industry for 20 years or more, and 298 non IR exposed controls. The examination includes an evaluation of the individual IR-exposure and an ophthalmological examination with special reference to the lens. In IR exposed workers 70 years of age and older there is a statistically significant increase of aphakia and of all types of cataract, subcapsular, cuneiform and nuclear, compared to the controls of the same age group. In the same age group the risk for an IR-exposed worker to have his vision reduced by cataract to 0.7 or less is 2.5 times as high as for non exposed controls (95% confidence interval 1.4-4.4). The risk that he will have to be operated for cataract is 12 times as high (95% confidence interval 2.6–53). It is concluded, that the occupational IR-exposure of the glass workers accelerates the development of senile changes in the lens. All workers with a high exposure to IR radiation should be equipped with adequate eye protection.
Psoriasis is associated with several extracutaneous manifestations of which ocular complications are common. Signs and symptoms of ocular psoriasis may be subtle and overlooked. The dermatologic literature has generally underaddressed these complications; however, a thorough understanding of ophthalmic involvement is important to the comprehensive care of patients with psoriasis.
We sought to provide a complete and up-to-date clinical guide on the manifestations and diagnostic considerations of ocular psoriasis.
PubMed and Google Scholar were used to find primary resources. The MeSH database of PubMed was used to link key ocular terms with the words "psoriasis," "psoriatic arthritis," and/or various psoriasis medications.
Ocular manifestations of psoriasis are discussed anatomically to allow for easy clinical reference. Complications include direct cutaneous effects such as eyelid involvement and blepharitis, and immune-mediated conditions such as uveitis.
Literature reviewed was primarily focused on English-language journals. In addition, older articles not included in the above electronic databases were underrepresented.
Ophthalmic complications of psoriasis are numerous and affect almost any part of the eye; however, they may be easily missed. Physicians should maintain a high index of suspicion that ophthalmic symptoms in patients with psoriasis may be related to their underlying disease, even though signs and symptoms are often vague. Screening and evaluation guidelines for ocular disease should be more clearly incorporated into the already large academic framework of psoriasis research and care.
On the basis of animal experiments there appears to be a theoretical chance that lens changes will occur in patients receiving PUVA treatment. In the published studies the incidence of lens changes in patients treated with PUVA is very low. In this study changes were observed both during PUVA treatment and during a long follow-up period. The absence of typical lens changes in patients aged 55 years and older is remarkable. A possible relationship between these findings and information obtained by experiment is discussed.
PUVA therapy has radically altered the management of severe psoriasis. It is of greatest benefit in those patients with extensive involvement, and in those unresponsive to conventional therapy. The long term side effects of PUVA currently limit its use to patients with disabling disease. The full extent of long term side effects has yet to be defined. In order to reduce the toxicity and improve the efficacy of PUVA, a better understanding of the molecular aspects of psoralen-DNA interaction, DNA repair, and mutagenesis is required. The action spectrum of PUVA in clearing psoriasis has yet to be defined. By limiting the spectrum of UVA exposure it may be possible to reduce some of the toxic effects of PUVA. The recent advances in the formulation of 8-MOP preparations has yielded a drug with more predictable pharmacokinetics and clinical response. Further research with newer psoralens may produce more effective and less toxic compounds. In the last ten years, PUVA has been both a valuable addition to dermatologists' clinical armamentarium and a useful tool in increasing our understanding of cellular biology and the interaction between ultraviolet radiation and biologic systems.
Photochemotherapy combined with psoralen, now widely used in the treatment of psoriasis, vitiligo, Andrews' disease and some other skin conditions, has been accepted as one of the potential factors that might contribute to the development of cataract. This view is based upon experimental animal studies. In the present study 408 patients receiving PUVA treatment in the period between 1977 and 1983 have been followed up for up to 6 years after the initiation of therapy. Repeated ophthalmological examinations were performed, particularly in order to detect any early signs of lens changes. In 20 patients development or increase of lens opacities could be observed. There is some evidence that in 3 of these 20 patients cataract formation was attributable to PUVA.
An epidemiologic investigation on the prevalence of cataract in glass workers is presented. The study includes 209 workers over 50 years of age exposed to infrared (IR) radiation in the Swedish manual glass industry for 20 years or more, and 298 non-IR-exposed controls. The examination includes an evaluation of the individual IR-exposure and an ophthalmological examination with special reference to the lens. In IR-exposed workers 70 years of age and older there is a statistically significant increase of aphakia and of all types of cataract, subcapsular, cuneiform and nuclear, compared to the controls of the same age group. In the same age group the risk for an IR-exposed worker to have his vision reduced by cataract to 0.7 or less is 2.5 times as high as for non-exposed controls (95% confidence interval 1.4-4.4). The risk that he will have to be operated for cataract is 12 times as high (95% confidence interval 2.6-53). It is concluded, that the occupational IR-exposure of the glass workers accelerates the development of senile changes in the lens. All workers with a high exposure to IR radiation should be equipped with adequate eye protection.
S ummary
PUVA, the combination of psoralen and long wave ultraviolet radiation is widely used in the management of psoriasis, vitiligo and several other dermatological disorders. The potential for long term treatment to cause ocular damage remains to be determined and despite the large numbers of patients who have received PUVA treatment, development of cataract is exceedingly rare. This paper discusses cataract formation, reviews the literature concerning the ocular complications of PUVA therapy and proposes guidelines for ocular protection during photochemotherapy.
The therapeutic benefit of ultraviolet light in certain diseases, notably psoriasis, with and without the addition of photosensitizing drugs, has been recognized for many years. The combination of a photoactive chemical and light defines the term photochemotherapy. The wavelength of light used is determined by the activation spectrum of the chemical agent. The interaction of the light and chemical produces a synergistic effect. The clinical, pharmacologic, and toxic effects of the Goeckerman regimen, PUVA therapy, chemoporphyrin therapy, and the treatment of hyperbilirubinemia are reviewed.
In some animal species, exposure of the unprotected eye to psoralen plus ultraviolet A (PUVA) therapy induces lens opacities. The relevance of these animal findings to human beings is not established. However, some case reports suggest that PUVA in human beings may increase the risk of lens abnormalities.
Our aim was to evaluate any possible associations between exposure to PUVA and increased risk of ocular lens abnormalities.
Since 1977 the PUVA follow-up study has periodically monitored the ocular status of 1237 cohort members with psoriasis using structured eye examinations. In our previous report we presented data results of the first 10 years of prospective study. This report includes data from two additional cycles of eye examinations that span an additional 14 years of follow-up.
Based on our data from the last pre-1993 to final eye examination (2004), compared with that observed for the earlier period (first ever to last pre-1993 eye examination), the age-adjusted incidence of cataract did not increase significantly (incidence rate ratio = 1.04, 95% confidence interval = 0.82-1.31). In both the univariate and multivariate analyses increasing exposure to PUVA was not associated with a higher risk of cataract.
Our cohort principally enrolled middle-aged or older patients so our data do not permit us to assess the effects of PUVA on the eyes of younger persons.
Increasing exposure to PUVA does not increase cataract risk among persons using eye protection at the rates used in our cohort.
Extensive psoriasis in 1,308 patients has been treated two or three times a week with oral 8-methoxypsoralen followed by high intensity, long-wave ultraviolet light (PUVA). Excluding 169 patients still under early treatment, psoriasis cleared in 88% and failed to clear in 3%. One percent dropped out due to complications of treatment, and 8% for other reasons. The twice-a-week schedule was superior for patients with lighter skin types. Once a remission was induced, there was no difference in its maintenance when patients were treated once a week, once every other week, or once every third week. Each of these schedules was superior to no maintenance treatment. Immediate side effects of the 45,000 treatments administered in the first 18 months of this study were uncommon, temporary, and generally mild. No clinically significant changes in laboratory screening or eye examinations attributable to PUVA have been uncovered.
Four groups of female Dutch-belted rabbits (Oryctulagus cuniculus) were given methoxsalen (12 mg/kg) or placebo by oral intubation and 1 hr later were exposed to UVA for either 2 or 8 hr. This procedure was repeated 5 days each week for 18 mo. A fifth group received no drug and no UVA exposure. The skin of the animals given methoxsalen and UVA showed signs of acute and chronic phototoxicity. Multiple peripheral blood parameters of hepatic, renal and hematologic function were normal and were not different between groups. Complete ophthalmoscopic examinations were performed periodically. No cataracts were seen in any of the animals. This data provides the perspective that in one species the daily dose of methoxsalen and UVA required to induce chronic cutaneous photosensitization is lower than the daily dose required to induce cataracts. it is inadvisable to interpret this data as suggesting that no risk exists for patients being treated with oral methoxsalen photochemotherapy. The experimental evidence supporting photosensitization as a cause of cataracts and implicating a role of lens DNA in this cataractogenesis is reviewed. Because methoxsalen-UVA alterations of lens DNA or protein could Lead to delayed onset of cataracts, and because of the serious nature and potential preventability of phototoxic lens opacification, appropriate protective eye wear is recommended for all patients receiving oral psoralen photochemotherapy.
A retrospective ocular study of patients receiving oral 8-MOP and exposure to solar irradiation for the treatment of vitiligo is presented. Fifteen patients between the ages of 20 and 40 years of age were selected who had been under therapy for 5 to 23 years. No ocular abnormalities were found.
Cataract prevalence data from two large U.S. sources were divided according to small geographic areas for which average annual sunlight hours were determined from a map prepared by the U.S. Weather Bureau. Several non-cataract disease controls were chosen from the same geographic locations (separately for each data set). It was found that the cataract-to-control ratios for persons aged 65 years or older were significantly larger in locations with large amounts of sunlight compared to those in locations with small amounts (P less than .05). Discussion of some possible biases in the data leads to the conclusion that the biases, if they exist, are probably not large. The authors believe, however, that more research should be done before the association between sunshine and cataract is considered established.
The use of 8-methoxypsoralen for treating psoriasis could prove hazardous if this photosensitizing agent enters the ocular
lens. Phosphorescence spectra of intact rat lenses reveal concentrations of 8-methoxypsoralen on the order 10(-5)M after intraperitoneal
injection of 8-methoxypsoralen. There is evidence that this drug can function as a photosensitizing agent, enhancing ultraviolet-induced
changes within the lens.
The photosensitizing effect of 8-methoxypsoralen in the eyes of laboratory animals was studied utilizing a high intensity grating monochromator as the light source. The action spectrum for this effect was found primarily in the long ultraviolet range with some activity demonstrated also in the mid ultraviolet. The maximum efficiency of long ultraviolet was found between 320 and 340 nm with decreasing efficiency to 330 nm and no effect for wavelengths longer than 380 nm.Guinea pigs were more susceptible to photosensitizing injury with psoralen than were rabbits and experimental data suggests that this is due to a difference in penetration of the 8-MP into the eye.When guinea pigs were given doses of 8-MP comparable to therapeutic doses in man no eye injury was detected.
During the last decade, psoralens have become increasingly popular in treating psoriasis. The well known photosensitizing action of these drugs has led to concern regarding potential ocular complications, particularly in patients receiving prolonged psoralen therapy. We have demonstrated that this drug can be found in humans and rat lenses and that its presence can lead to a photosensitized enhancement of lenticular fluorescence and phosphorescence. At higher doses, cataracts will develop in experimental animals. We have demonstrated that photoaddition products are generated with certain aromatic amino acid residues in the lens proteins (particularly tryptophan) as well as with the pyrimidine bases of DNA, resulting in the permanent retention of this compound within the ocular lens. Free 8-MOP can also be detected in human lenses for at least 12 h following oral ingestion. When the lens is kept in the dark, the free 8-MOP diffuses out within 12--24 hr. Thus it is possible to prevent photochemical reactions by avoiding exposure to ambient light for 12--24 h following ingestion of the drug. Special glasses, capable of reflecting all UV radiation (up to 400 nm) while completely transmitting the visible radiation (400--750 nm), may also protect the patient.
The optical performance of some commercially-available tined lenses is discussed. There is a wide variation in the UV absorbing power of sunglasses although adequate protection against solar UV-A can be achieved with some, but not all, polarizing material. The darkness of a tint is not an indication of its likely performance within the ultraviolet bands and it is possible that lenses could be produced that lacked any significant tint yet absorbed strongly throughout the UV region.
— We have previously demonstrated that 8-methoxypsoralen (8-MOP) can be found in the lenses of rats injected (i.p.) with this drug, and that its presence can lead to a photosensitized enhancement of lenticular fluorescence. The cutaneous photosensitizing properties of psoralens are thought to be mediated via their excited triplet states, resulting in photoaddition cyclobutane products between pyri-midine bases and 8-MOP. We have now investigated the possibility that similar types of photoadducts could be generated between 8-MOP and the aromatic amino acid residues in lens proteins. Our experiments involved in vitro irradiation (at 360 nm) of aqueous solutions of 0.1 mM 8-MOP plus purified alpha, beta, or gamma crystallins from calf or normal human (under 20 years of age) lenses. UV absorption and fluorescence emission spectra were measured before and after radiation, and aliquots from all experiments were frozen and kept in the dark for subsequent phosphorescence and EPR spectroscopy. Similar experiments were performed with irradiated aqueous solutions of tryptophan or thymine plus 8-MOP. All controls consisted of solutions kept in the dark. NMR spectra demonstrated that the hydrogen atoms at the 3,4 and 4',5' positions of the 8-MOP molecule were lost following irradiation, suggesting that these two sites were involved in the photoproduct formed between tryptophan and 8-MOP. These studies strongly suggest that 8-MOP is capable of forming photoaddition products with tryptophan and with lens proteins as well as DNA in vivo, resulting in its permanent retention within the ocular lens.
An estimate of the UV transmission of sunglasses is often made in Dermatology Departments by employing the irradiation source used for PUVA therapy and a UV-A meter. The object of making these measurements is to assess the UV opacity of the glasses in natural sunlight. The present communication examines the adequacy of this simple experimental technique and concludes that, in general, the results obtained are unlikely to lead to a misleading impression.
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Refeil·ed Ja1111ary 18, /983
Department of Dermatology Karolin�ka �jukhuscl S-10401 Stockholm
- Lena Rönnerfält
Lena Rönnerfält, M.D.
Department of Dermatology
Karolin�ka �jukhuscl
S-10401 Stockholm