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2.
Br J Dermatol ; 178(4): e279-e285, 2018 04.
Article in English | MEDLINE | ID: mdl-29441525

ABSTRACT

Results of clinical trials are the most important information source for generating external clinical evidence. The use of different outcomes across trials, which investigate similar interventions for similar patient groups, significantly limits the interpretation, comparability and clinical application of trial results. Core outcome sets (COSs) aim to overcome this limitation. A COS is an agreed standardized collection of outcomes that should be measured and reported in all clinical trials for a specific clinical condition. The Core Outcome Set Initiative within the Cochrane Skin Group (CSG-COUSIN) supports the development of core outcomes in dermatology. In the second CSG-COUSIN meeting held in 2017, 11 COS development groups working on skin diseases presented their current work. The presentations and discussions identified the following overarching methodological challenges for COS development in dermatology: it is not always easy to define the disease focus of a COS; the optimal method for outcome domain identification and level of detail needed to specify such domains is challenging to many; decision rules within Delphi surveys need to be improved; appropriate ways of patient involvement are not always clear. In addition, there appear to be outcome domains that may be relevant as potential core outcome domains for the majority of skin diseases. The close collaboration between methodologists in the Core Outcome Set Initiative and the international Cochrane Skin Group has major advantages for trialists, systematic reviewers and COS developers.


Subject(s)
Clinical Trials as Topic/standards , Dermatology/standards , Outcome Assessment, Health Care/standards , Decision Making , Humans , Interprofessional Relations
3.
J Eur Acad Dermatol Venereol ; 32(2): 245-253, 2018 Feb.
Article in English | MEDLINE | ID: mdl-28898541

ABSTRACT

BACKGROUND: Biologics have greatly improved psoriasis management. However, primary and secondary non-response to treatment requires innovative strategies to optimize outcomes. OBJECTIVE: To describe the use of combined treatment of biologics with conventional systemic agents or phototherapy in daily clinical practice. METHODS: We collected data on frequency of use, demographics, treatment characteristics and drug survival of biologics combined with conventional systemic agents or phototherapy in five PSONET registries. RESULTS: Of 9922 biologic treatment cycles, 982 (9.9%) were identified as combination treatment. 72.9% of treatment cycles concerned concomitant use of methotrexate, 25.3% concerned concomitant UVB therapy, acitretin or cyclosporin and 1.8% concerned combined treatment with PUVA, fumaric acids or a second biologic. Substantial variation was detected in type and frequency of combination treatments prescribed across registries. Patients initiated on combined treatment had generally severe disease and were affected with psoriasis for many years. The extent to which patients had been priory treated with biologic monotherapy and the proportion of patients affected with psoriatic arthritis differed between registries. Survival rates for etanercept, adalimumab, infliximab and ustekinumab with methotrexate ranged between 43 and 92%, 28 and 83%, 65 and 87% and 53 and 77%, respectively, across registries after one year with no consistent superior survival for a particular biologic. Longest survival on a biologic combined with methotrexate, acitretin or cyclosporin was 103, 78 and 34 months, respectively. CONCLUSION: Methotrexate was the most commonly used concomitant treatment for patients on a biologic. Wide geographical variations in treatment selection and persistence of combination treatment exist. Data derived from ongoing studies may help to determine whether combined treatment is superior to biologic monotherapy.


Subject(s)
Biological Products/therapeutic use , Dermatologic Agents/therapeutic use , PUVA Therapy , Psoriasis/therapy , Acitretin/therapeutic use , Adalimumab/therapeutic use , Austria , Combined Modality Therapy , Cyclosporine/therapeutic use , Czech Republic , Drug Therapy, Combination , Etanercept/therapeutic use , Female , Fumarates/therapeutic use , Humans , Infliximab/therapeutic use , Israel , Italy , Kaplan-Meier Estimate , Male , Methotrexate/therapeutic use , Middle Aged , Netherlands , Registries , Severity of Illness Index , Ustekinumab/therapeutic use
4.
Br J Dermatol ; 178(3): 640-649, 2018 03.
Article in English | MEDLINE | ID: mdl-28722209

ABSTRACT

BACKGROUND: Harmonization of outcome measures is needed to increase the value of clinical trials on nail psoriasis. OBJECTIVES: To provide the first step in core outcome set (COS) development for nail psoriasis. METHODS: A systematic review was performed to identify outcome instruments and corresponding outcome domains used in (ongoing) randomized controlled trials. RESULTS: Identified outcome domains included clinical signs, quality of life, symptoms and delivery of care. The Nail Psoriasis Severity Index (NAPSI) was the most commonly used measure to assess clinical signs (74% of studies). Other outcome instruments used included the Nail Area Severity score, composite fingernail score, a Physician's Global Assessment, individual nail features or a combination of these. Heterogeneity in type and reporting (e.g. NAPSI 50, NAPSI 75) of outcome instruments was high and characteristics were often insufficiently reported. In total 43% of studies assessed quality of life, with 3% of studies using a nail psoriasis-specific tool. Assessment of symptoms and delivery of care was limited. CONCLUSIONS: Heterogeneity in the type and reporting of nail psoriasis outcome instruments needs to be addressed in the process towards COS development. Sufficient reporting of instrument characteristics should be encouraged. As nail psoriasis is generally assessed secondarily to psoriasis of the skin or joints, collaboration between different research groups in COS development is needed.


Subject(s)
Nail Diseases/therapy , Psoriasis/therapy , Activities of Daily Living , Delivery of Health Care/standards , Humans , Patient Reported Outcome Measures , Quality of Life , Randomized Controlled Trials as Topic , Research Design , Severity of Illness Index , Treatment Outcome
5.
Trials ; 18(1): 52, 2017 02 02.
Article in English | MEDLINE | ID: mdl-28148280

ABSTRACT

BACKGROUND: The introduction of anti-tumor necrosis factor medications has revolutionized the treatment of psoriasis with achievement of treatment goals (Psoriasis Area and Severity Index score 75, remission) that are not usually met with conventional systemics. Nevertheless, some patients continue to experience persistent disease activity or treatment failure over time. Strategies to optimize treatment outcomes include the use of concomitant methotrexate, which has demonstrated beneficial effects on pharmacokinetics and treatment efficacy in psoriasis and other inflammatory diseases. METHODS: This is an investigator-initiated, multicenter randomized controlled trial (RCT) designed to compare the combination treatment of adalimumab and methotrexate with adalimumab monotherapy in patients with psoriasis. The primary outcome is adalimumab drug survival at week 49. Other outcomes include improvement in disease severity and quality of life, tolerability, and safety. Moreover, anti-adalimumab antibodies and adalimumab serum concentrations will be measured and correlations between genotypes and clinical outcomes will be assessed. Patient recruitment started in March 2014. Up to now, 36 patients have been randomized. Many more patients have been (pre)screened. A total of 93 patients is desired to meet an adequate sample size. In our experience, the main limitation for recruitment is prior adalimumab therapy and intolerability or toxicity for methotrexate in the past. DISCUSSION: OPTIMAP is the first RCT to examine combination therapy with adalimumab and methotrexate in a psoriasis population. With data derived from this study we expect to provide valuable clinical data on long-term treatment outcomes. These data will be supported by assessment of the impact of concomitant methotrexate on adalimumab pharmacokinetics. Furthermore, the influence of several single nucleotide polymorphisms on adalimumab response will be analyzed in order to support the development of a more personalized approach for this targeted therapy. TRIAL REGISTRATION: NTR4499 . Registered on 7 April 2014.


Subject(s)
Adalimumab/administration & dosage , Biological Products/administration & dosage , Immunosuppressive Agents/administration & dosage , Methotrexate/administration & dosage , Psoriasis/drug therapy , Skin/drug effects , Tumor Necrosis Factor-alpha/antagonists & inhibitors , Adalimumab/adverse effects , Biological Products/adverse effects , Clinical Protocols , Drug Therapy, Combination , Humans , Immunosuppressive Agents/adverse effects , Methotrexate/adverse effects , Netherlands , Psoriasis/diagnosis , Psoriasis/immunology , Quality of Life , Remission Induction , Research Design , Severity of Illness Index , Single-Blind Method , Skin/immunology , Skin/pathology , Time Factors , Treatment Outcome , Tumor Necrosis Factor-alpha/immunology
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