**4.3 Drug holidays**

282 Psoriasis

Lupus syndrome

ailments

joint pain

shock

4th infusion Anaphylactic

For patient 3 (see table), resistant to adalimumab from the start, adverse effects arose from the first infliximab infusion: chest pain with normal tracing on the ECG, unremarkable blood pressure and pulse. The second infusion had to be stopped (faintness) and resumed the following week, with premedication. On the following three days, the patient had to visit the emergency department for incapacitating inflammatory joint pain. The patient was off work for 24 hours. The clinical result was good (PASI reduced to 80%). The third infusion gave rise to the same joint pains, increased, diffused, with headaches. The treatment was discontinued and replaced with ustekinumab, with no tolerance problem.

Patient 4, who was resistant to etanercept, initially showed an excellent response to infliximab (98% PASI improvement). After around 10 months, the recurrence preceding each infusion came earlier and earlier. The treatment was discontinued after 17 months, after it had lost all effect and inflammatory, atypical joint pain had developed for several days and then weeks following the last two infusions, despite the use of methotrexate

reaction

Anaphylactic

**Description Severity Treatment Evolution** 

Severe Disconti-

Severe Disconti-

Moderate Disconti-

Severe Prevention for following infusions and progressive desensitization

Moderate Prevention for following infusions

nuation of infliximab

nuation of infliximab

nuation of infliximab

nuation of infliximab Complete resolution

Complete resolution

Complete resolution

Complete resolution

Good tolerance; reduced efficacy

Good tolerance but clinical relapse

**Age Sex Prior** 

**1** 43 F Infliximab,

**5** 41 F Infliximab,

**6** 63 M Etanercept,

Table 3. Observed adverse events

(begun very late).

Etanercept

Adalimumab

**biotherapies**

Adalimumab

**3** 40 M Adalimumab 1st infusion Arthralgia,

**4** 39 M Etanercept 15 months Inflammatory

**Time to onset** 

1st infusion after a 9-month stop

2nd infusion after 2-year stop

**2** 36 F Etanercept 9 months Lupus Severe Disconti-

10 patients experienced temporary interruptions to treatment. The reasons varied widely.

Two patients were not compliant: they forgot appointments on several occasions and canceled due to 'lack of time'. Several times, this led to delays of up to three months. This did not affect tolerance for either patient, but one of the two had an insufficient clinical response. The doctor therefore suggested a treatment more in line with their lifestyle.

One patient personally chose to have a drug holiday; he was able to restart treatment successfully and without adverse events, after recurrence of psoriasis.

One patient (already mentioned above) had to interrupt infliximab for nearly six months due to repeated heart surgery.

One patient interrupted treatment for several months, as his Social Security status was unsettled, and he was no longer allowed to claim his treatment fees.

One patient had to go on a extended trip abroad.

One patient interrupted treatment for a clinical drug trial.

Several patients who had received infliximab therapy for several years recently expressed interest in switching to a biological therapy administered subcutaneously, which they had heard about and considered easier to manage. However, the beginning of treatment is often difficult (partial recurrence following the discontinuation of infliximab), and efficacy of the new treatment is not always immediate. Three patients experienced the change badly and tolerated the beginning of the recurrence poorly. Despite medical explanations and the concern for avoiding drug 'shopping', they returned to their prior infliximab treatment. The reintroduction was accompanied by manifestations of hypersensitivity in one case only.

#### **4.4 Adherence to treatment**

Infliximab treatment usually involves strong adherence by the patient. When efficacy is maintained in the long-term, the patient is especially grateful for this invariability. All patients consider not having to undergo treatment at home as being very positive. The

Infliximab Therapy for Plaque Psoriasis: The UCL Experience 285

From this series of 50 patients treated by infliximab, we can confirm the efficacy of the product: PASI 100 (46%), PASI 90-99 (15%), PASI 75-89 (15%), PASI 50-74 (10%). In around half the cases, this efficacy is reduced over time (26%), or completely lost (34%); it is maintained in 40% of cases. In this study, we have a tendency for a more sustained response among complete initial responders in comparison with partial initial responders (47 vs 31%). We always present infliximab to new patients as the most effective therapy in principle, warning them however about this risk of efficacy loss. The concurrent use of methotrexate could be considered, having proved its worth in indications other than plaque psoriasis (Kamili et al., 2011). Patient satisfaction is increased, despite the need for infusions in specialized and equipped centers. The occurrence of hypersensitivity reactions during infusion must be monitored and the risk of arthritic and lupus reactions must be known.

The author has participated in clinical trials, given lectures, and participated in expert panels funded by Schering-Plough/Merck. He has also served as consultant for Schering-

Efficacy and safety of infliximab monotherapy for plaque-type psoriasis: a randomised trial.

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Duarte AA, Chehin FB. Moderate to severe psoriasis treated with infliximab - 53 patients:

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Korswagen LA, Bartelds GM, Krieckaert CL et al. Venous and arterial thromboembolic

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Puig L. Efficacy of treatment with infliximab in patients with moderate-severe psoriasis and

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events in adalimumab-treated patients with antiadalimumab antibodies: a case

infliximab for severe recalcitrant psoriasis: evidence for efficacy and high incidence

high needs of therapy. A retrospective study of 43 Patients. Actas Dermosifiliogr.

biologic interventions for psoriasis 2009. Br J Dermatol. 2009 Nov; 161 (5): 987-1019.

Chaudhari U, Romano P, Mulcahy LD, Dooley LT, Baker DG, Gottlieb AB.

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**5. Conclusion** 

**6. Conflict of interest** 

257-263.

(5): 539-44.

2008;99 Supl 4:30-5.

Plough/Merck.

**7. References** 

inconvenience of hospitalized infusion is deemed negligible by most patients. For many, this aspect of full care is even deemed to be positive. One possible problem, in psychological terms, is that the infusions take place in hospitals which treat other ambulatory patients, in particular patients undergoing cancer chemotherapy. This co-existence can be difficult to experience for some patients affected with psoriasis. It is easier to manage in large hospitals, which can organize their wards accordingly.
