XI. PUVA TREATMENT PROTOCOL
A. INITIAL EXPOSURE:
The initial dosage and UVA exposure should be determined according to the guidelines presented previously under IX.B.1, and the information presented in this section.
Skip Type |
History |
Recommended Joules/cm2
|
I |
Always burn, never tan (Patients with Erythrodermic psoriasis are to be classed as Type I for determination of UVA dosage.) |
0.5 J/cm2
|
II |
Always burn, but sometimes tan |
1.0 J/cm2
|
III |
Sometimes burn, but always tan |
1.5 J/cm2
|
IV |
Never burn, always tan |
2.0 J/cm2
|
|
Physician Examination
|
|
V
|
Moderately pigmented |
2.5 J/cm2
|
VI
|
Blacks |
3.0 J/cm2
|
B. CLEARING PHASE:
Specific recommendations for patient treatment are as follows:
SKIN TYPES I, II & III.
Patients with skin types I, II and III may be treated 2 or 3 times per week. UVA exposure may be held constant or increased by up to 1.0 Joule/cm2 at each treatment, according to the patient's response. If erythema occurs, however, do not increase exposure time until erythema resolves. The severity and extent of the patient's erythema may be used to determine whether the next exposure should be shortened, omitted, or maintained at the previous dosage. See Adverse Reactions section for additional information.
SKIN TYPES IV, V & VI.
Patients with skin types IV, V and VI may be treated 2 or 3 times per week. UVA exposure may be held constant or increased by up to 1.5 Joules/cm2 at each treatment unless erythema occurs. If erythema occurs, follow instructions outlined above in the procedures for patients with skin types I, II and III.
ERYTHRODERMIC PSORIASIS.
Patients with erythrodermic psoriasis should be treated with special attention because pre-existing erythema may obscure observations of possible treatment-related phototoxic erythema. These patients may be treated 2 or 3 times per week, as a Type I patient.
MISCELLANEOUS SITUATIONS:
a. If there is no response after a total of 10 treatments, the exposure of UVA energy may be increased by an additional 0.5-1.0 Joules/cm2 above the prior incremental increases for each treatment. (Example: a patient whose exposure dosage is being increased by 1.0 Joule/cm2 may now have all subsequent doses increased by 1.5-2.0 Joules/cm2.)
b. If there is no response, or only minimal response, after 15 treatments, the dosage of methoxsalen may be increased by 10 mg. (a one-time increase in dosage). This increased dosage may be continued for the remainder of the course of treatment but should not be exceeded.
c. If a patient misses a treatment, the UVA exposure time of the next treatment should not be increased. If more than one treatment is missed, reduce the exposure by 0.5 Joules/cm2 for each treatment missed.
d. If the lower extremities are not responding as well as the rest of the body and do not show erythema, cover all other body area and give 25 percent of the present exposure dose as an additional exposure to the lower extremities. This additional exposure to the lower extremities should be terminated if erythema develops on these areas.
e. Non-responsive psoriasis: If a patient's generalized psoriasis is not responding, or if the condition appears to be worsening during treatment, the possibility of a generalized phototoxic reaction should be considered. This may be confirmed by the improvement of the condition following temporary discontinuance of this therapy for two weeks. If no improvement occurs during the interruption of treatment, this patient may be considered a treatment failure.
C. ALTERNATIVE EXPOSURE SCHEDULE:
As an alternative to increasing the UVA exposure at each treatment, the following schedule may be followed; this schedule may reduce the total number of Joules/cm2 received by the patient over the entire course of therapy.
1. Incremental increases in UVA exposure for all patients may range from 0.5 to 1.5 Joules/cm2, according to the patient's response to therapy.
2. Once Grade 2 clearing (see Table 2) has been reached and the patient is progressing adequately, UVA dosage is held constant. This dosage is maintained until Grade 4 clearing is reached.
3. If the rate of clearing significantly decreases, exposure dosage may be increased at each treatment (0.1-1.5 Joules/cm2) until Grade 3 clearing and a satisfactory progress rate is attained. The UVA exposure will be held constant again until Grade 4 clearing is attained. These increases may be used also if the rate of clearing significantly decreases between Grade 3 and Grade 4 response. However, the possibility of a phototoxic reaction should be considered; see Non-responsive Psoriasis, above.
4. In summary, this schedule raises slightly the increments (Joules/cm2) of UVA dosage, but limits these increases to those periods when the patient is not responding adequately. Otherwise, the UVA exposure is held at the lowest effective dose.
D. MAINTENANCE PHASE:
The goal of maintenance treatment is to keep the patient as symptom-free as possible with the least amount of UVA exposure.
SCHEDULE OF EXPOSURES:
When patients have achieved 95 percent clearing, or Grade 4 response (Table 2), they may be placed on the following maintenance schedules (M1 - M4), in sequence. It is recommended that each maintenance schedule be adhered to for at least 2 treatments (unless erythema or psoriatic flare occurs, in which case see (2a) and (2b) below).
Maintenance Schedules |
M1 – once/week |
M2 – once/2 weeks |
M3 – once/3 weeks |
M4 – p.r.n. (i.e., for flares) |
LENGTH OF EXPOSURE:
The UVA exposure for the first maintenance treatment of any schedule (except M4 as noted below) is the same as that of the patient's last treatment under the previous schedule. For skin types I-IV, however, it is recommended that the maximum UVA dosage during maintenance treatments not exceed the following:
Skin Types |
Joules/cm2/treatment |
I |
12 |
II |
14 |
III |
18 |
IV |
22 |
If the patient develops erythema or new lesions of psoriasis, proceed as follows:
a. Erythema: During maintenance therapy, the patient's tan and threshold dose for erythema may gradually decrease. If maintenance treatments produce significant erythema, the exposure to UVA should be decreased by 25 percent until further treatments no longer produce erythema.
b. Psoriasis: If the patient develops new areas of psoriasis during maintenance therapy (but still is classified as having a Grade 4 response), the exposure to UVA may be increased by 0.5-1.5 Joules/cm2 at each treatment; this is appropriate for all types of patients. These increases are continued until the psoriasis is brought under control and the patient is again clear. The exposure being administered when this clearing is reached should be used for further maintenance treatment.
FLARES DURING MAINTENANCE:
If the patient flares during maintenance treatment (i.e., develops psoriasis on more than 5 percent of the originally involved areas of the body) his maintenance treatment schedule may be changed to the preceding maintenance or clearing schedule. The patient may be kept on his schedule until again 95 percent clear. If the original maintenance treatment schedule is unable to control the psoriasis, the schedule may be changed to a more frequent regimen. If a flare occurs less than 6 weeks after the last treatment, 25 percent of the maximum exposure received during the clearing phase, may be used and then proceed with the clearing schedule previously followed for this patient. (At 95 percent clearing follow regular maintenance until the optimum maintenance schedule is determined for the patient.) If more than 6 weeks have elapsed since the last treatment was given, treat patients as if they were beginning therapy insofar as exposure dosages are concerned, since their threshold for erythema may have decreased.
Table 1. Grades of Erythema
Grade |
Erythema Level |
0 |
No erythema |
1 |
Minimally perceptible erythema – faint pink |
2 |
Marked erythema but with no edema |
3 |
Fiery erythema with edema |
4 |
Fiery erythema with edema and blistering |
Table 2. Response to Therapy
Grade |
Criteria |
Percent Improvement (compared to original extent of disease) |
-1 |
Psoriasis worse |
0 |
0 |
No change |
0 |
1 |
Minimal improvement – slightly less scale and/or erythema |
5-20 |
2 |
Definite improvement – partial flattening of all plaques – less scaling and less erythema |
20-50 |
3 |
Considerable improvement – nearly complete flattening of all plaques but borders of plaques still palpable |
50-95 |
4 |
Clearing; complete flattening of plaques including borders; plaques may be outlined by pigmentation |
95 |
XII. HOW SUPPLIED:
8-MOP Capsules, each containing 10 mg of methoxsalen (8-methoxypsoralen) are available in pink-colored hard gelatin capsules in amber glass bottles of 50 (NDC 0187-0651-42), with ICN imprinted on the cap of the capsule and 600 imprinted on the body of the capsule.
Store at 25°C (77°F); excursions permitted to 15°C- 30°C (59°F- 86°F).
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