Expert Consensus on a Set of Outcomes to Assess the Effectiveness of Biologic Treatment in Psoriatic Arthritis: The MERECES Study.

OBJECTIVE: To reach a consensus on the instruments to be used in clinical practice to evaluate the effectiveness of biological disease-modifying antirheumatic drug (bDMARD) treatment in patients with psoriatic arthritis (PsA) in the short to medium term (3-6 mos), and to establish the minimum health outcomes for treatment continuation. METHODS: A 2-round Delphi questionnaire was developed based on both the information gathered in the literature review and 4 discussion groups. The suitability and feasibility of the proposed sets of instruments were assessed on a 7-point Likert scale. Consensus was established when at least 75% of healthcare professionals (HCP) reached agreement. To define a minimum health outcome to continue treatment, a combination of 4 disease activity states and 3 health-related quality of life states were defined for 3 hypothetical patient profiles. HCP were given a dichotomous choice (yes/no) to respond to whether they would continue treatment in each case. RESULTS: The second round was completed by 106 HCP. Consensus was reached on the use of (1) Disease Activity in Psoriatic Arthritis + Psoriatic Arthritis Impact of Disease (PsAID12) or minimal disease activity + PsAID12 + C-reactive protein, in peripheral PsA; and (2) Ankylosing Spondylitis Disease Activity Score + PsAID12, in axial PsA. Health outcomes considered sufficient to continue treatment were stricter for bDMARD-naive patients than for patients who failed several bDMARD. CONCLUSION: To the best of our knowledge, this is the first multidisciplinary consensus on a set of outcomes for the evaluation of bDMARD effectiveness in PsA, in routine clinical practice.

Preliminary observation with dronabinol in patients with intractable pruritus secondary to cholestatic liver disease.

Pruritus due to cholestatic liver disease can be particularly difficult to manage and frequently is intractable to a variety of medical therapies. The aim of our study is to evaluate the efficacy of delta-9-tetrahydrocannabinol (delta-9-THC) for intractable cholestatic related pruritus (ICRP) that has failed conventional (and unconventional) remedies. Three patients were evaluated for plasmapheresis because of ICRP. All 3 patients had previously been extensively treated with standard therapies for ICRP including: diphenhydramine, chlorpheniramine, cholestyramine, rifampicin, phenobarbital, doxepin, naltrexone, UV therapy, and topical lotions. Even multiple courses of plasmapheresis were performed without any benefit for the intractable pruritus. All patients reported significant decreases in their quality of life, including lack of sleep, depression, inability to work, and suicidal ideations. All patients were started on 5 mg of delta-9-THC (Marinol) at bedtime. All 3 patients reported a decrease in pruritus, marked improvement in sleep, and eventually were able to return to work. Resolution of depression occurred in two of three. Side effects related to the drug include one patient experiencing a disturbance in coordination. Marinol dosage was decreased to 2.5 mg in this patient with resolution of symptoms. The duration of antipruritic effect is approximately 4-6 hrs in all three patients suggesting the need for more frequent dosing. Delta-9-tetrahydrocannabinol may be an effective alternative in patients with intractable cholestatic pruritus.