A somatization comorbidity phenotype impacts response to therapy

Background Comorbidities may contribute to disease activity and treatment response in rheumatoid arthritis (RA) patients. We defined a somatization comorbidity phenotype (SCP) and examined its influence on response to certolizumab pegol (CZP) using data from the PREDICT trial. Methods Patients in PREDICT were randomized to the patient-reported Routine Assessment of Patient Index Data 3 (RAPID3) or physician-based Clinical Disease Activity Index (CDAI) for treatment response assessment. Post-hoc analyses identified patients with the SCP, which included diagnosis of depression, fibromyalgia/myalgias, and/or use of medications indicated for treatment of depression, anxiety, or neuropathic pain. The effect of the SCP on RAPID3 or CDAI response at week 12 and low disease activity (LDA; Disease Activity Score in 28 joints based on erythrocyte sedimentation rate ≤ 3.2) at week 52, in week-12 responders, was analyzed using non-parametric analysis of covariance (ANCOVA). Results At baseline, 43% (313/733) of patients met the SCP classification. Patients with the SCP were 9% more likely to withdraw from the trial. American College of Rheumatology 20% (ACR20), ACR50, and ACR70 responses were 5–14% lower among those with the SCP, and 11% more patients reported adverse events (AEs). Patients without SCP in the CDAI arm were twice as likely to achieve LDA at week 52 compared with those with SCP (32% versus 16%). No differentiation by SCP was observed in the RAPID3 arm (pooled result 21.5%). Conclusions We operationalized a potentially important somatization comorbidity phenotype in a trial setting that was associated with a substantially lower likelihood of treatment response and a higher frequency of AEs. Including large numbers of patients with this phenotype in RA trials may reduce the measured clinical effectiveness of a new molecule. Trial registration ClinicalTrials.gov, NCT01255761 . Registered on 6 December 2010.

A model of phenotype relationship among several disorders frequently

Twin pairs in analyses of the association between somatic comorbidity

Comorbidity, misdiagnoses, and the diagnostic odyssey in patients with hypermobile Ehlers-Danlos syndrome - Genetics in Medicine Open

Clonal hematopoiesis and inflammation: Partners in leukemogenesis and comorbidity - ScienceDirect

Mapping phenotypic and aetiological associations between ADHD and physical conditions in adulthood in Sweden: a genetically informed register study - The Lancet Psychiatry

Somatic symptom disorder (SSD) - what is it? Definition and information.

Functional neurological disorder: new subtypes and shared mechanisms - The Lancet Neurology

Phenotypic associations between OCD and other psychiatric disorders

PDF) Response to: “A somatization comorbidity phenotype impacts response to therapy in rheumatoid arthritis: post hoc results from the certolizumab pegol phase 4 PREDICT trial”

Nutrients, Free Full-Text