Dramatic improvement of severe acne pustolosa after adalimumab in a patient with ulcerative colitis.
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ABSTRACT:
SUBMITTER: Rispo A
PROVIDER: S-EPMC4831381 | biostudies-other | 2016 Apr
REPOSITORIES: biostudies-other
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Project description:BackgroundTreatment targets for ulcerative colitis are evolving towards achievement of endoscopic improvement and remission in addition to symptom resolution. It remains to be accurately quantified what proportion of patients with symptom resolution have residual endoscopic activity that might warrant treatment modification.AimTo quantify the prevalence of endoscopic improvement and remission amongst ulcerative colitis patients with various permutations of patient-reported outcomes.MethodsIndividual participant data from active intervention and placebo arms of clinical trials of infliximab, golimumab, vedolizumab and tofacitinib were pooled to estimate the prevalence of endoscopic improvement (Mayo endoscopic sub-score [MES] 0 or 1) and remission (MES 0) scores with various permutations of the rectal bleeding sub-score (RBS) and stool frequency sub-score (SFS) of the Mayo score, following induction (6-8 weeks) and maintenance (30-54 weeks) therapy. Subgroup analyses were performed by year of publication and centrally read endoscopy scoring.ResultsData from 2586 trial participants were analysed. Using locally scored endoscopy, the prevalence of endoscopic improvement and remission was highest among participants with a RBS 0 + SFS 0 post-induction (MES 0/1:81%, [95% CI 78-84]; MES 0:29% [26-33]) and during maintenance (MES 0/1:91% [87-93]; MES 0:57% [52-62]). Prevalence estimates were lower for more recently performed trials (P < .01). In comparison to locally scored endoscopy, when using central endoscopy scoring, the prevalence of endoscopic improvement and remission was lower post-induction (MES 0/1 57% [50-64], P < .001; MES 0 15% [11-21], P = .09) and during maintenance (MES 0/1 74% [67-81], P = .001; MES 0 31% [24-38], P = .001) for participants achieving a RBS 0 + SFS 0.ConclusionsApproximately 8 of 10 patients with normalisation of rectal bleeding and stool frequency have improvement in endoscopic disease activity, whereas approximately only half of these patients have endoscopic remission.
| S-EPMC6989392 | biostudies-literature
Project description:BackgroundA gap remains in documenting the impact of anti-tumor necrosis factor therapy on disease burden in ulcerative colitis (UC) patients treated in a real-world setting. The use of patient-reported outcomes (PROs) has been discussed as a primary endpoint in the context of the FDA PRO Guidance, for labelling purposes. Specifically, the efficacy and safety of adalimumab have been demonstrated in pivotal trials; however, data are needed to understand how clinical results translate into improvements in key aspects of the daily lives of UC patients, such as symptoms, health-related quality of life (HRQoL), and disability.AimTo assess real-world effectiveness of adalimumab on PRO measures in patients with moderate-to-severe UC.MethodsUCanADA was a single arm, prospective, 1-year multicenter Canadian post-marketing observational study in which multiple PRO questionnaires were completed-with psychologic distress/depression symptoms as the primary endpoint-by patients with moderate-to-severe UC. Assessments were performed during patients' routine care visit schedule, which was at the initiation of adalimumab (baseline), after induction (approximately 8 wk), and 52 wk after baseline. Additional optional assessments between weeks 8 and 52 were collected at least once but no more than two times during this period. Serious safety events and per-protocol adverse events were collected.ResultsFrom 23 Canadian centres, 100 patients were enrolled and 48 completed the study. Measured with the Patient Health Questionnaire-9 items at week 52, 61.5% (40/65) [95% confidence interval (CI): 49.7%-73.4%] of the patients improved in psychologic distress/depression symptoms, which was slightly higher in completers [65.9% (29/44); 95%CI: 51.9%-79.9%)]. At week 52, clinical response and clinical remission were achieved respectively by 65.7% (44/73) and 47.8% (32/73) of the patients. The odds of improving depressive symptoms for those achieving a clinical remission at week 52 was 7.94 higher compared with those not achieving a clinical remission (CI: 1.42, 44.41; P = 0.018). Significant changes from baseline to weeks 8 and 52 were observed in disability, HRQoL, and fatigue. Meaningful improvement was reported in work impairment.ConclusionAt week 52, over 60% of the UCanADA patients had depressive symptoms significantly reduced, as well as HRQoL, fatigue symptoms, and work impairment improved. No new safety signals were detected.
| S-EPMC9494926 | biostudies-literature
Project description:The aim of the study was to compare adalimumab or golimumab with infliximab in patients with moderately-to-severely active ulcerative colitis (UC).This paper was prepared according to the PRISMA guidelines. The systematic literature search was performed in PubMed, Embase, and Cochrane Library. No direct head-to-head comparisons for infliximab vs. adalimumab or golimumab were available so an indirect comparison according to the Bucher method was performed after a homogeneity evaluation of the included studies.Six RCTs were included in the systematic review. An indirect comparison was performed, which revealed that infliximab was more effective in inducing clinical response compared with both doses of adalimumab (160/80 mg or 80/40 mg; p < 0.05), and, in clinical remission, infliximab was more effective than adalimumab (only for a dosage regime of 80/40 mg; p < 0.05). No statistically significant differences in clinical response and clinical remission were observed between infliximab and golimumab in the induction phase. A significant (p < 0.05) advantage only of infliximab compared with adalimumab at doses of 80/40 mg and 80/160 mg was seen in terms of clinical response in the maintenance phase (up to 52-54 weeks). The indirect comparison revealed that serious adverse events were significantly more frequent among patients treated with a maintenance dose of 100 mg of golimumab compared with those treated with infliximab (p < 0.05).No significant differences in efficacy in the maintenance phase between infliximab and golimumab or adalimumab were revealed. Infliximab proved to be more effective than adalimumab but of similar efficacy to that of golimumab in the induction phase.
| S-EPMC5016577 | biostudies-other
Project description:Ixekizumab is a selective monoclonal antibody targeting interleukin-17A, approved for the treatment of chronic plaque psoriasis. It has rarely been associated with inflammatory bowel disease (IBD) in randomized trials only. We report a unique case of severe new-onset ulcerative colitis in a young male complicated by cytomegalovirus infection who was on ixekizumab therapy for plaque psoriasis. We recommend that clinicians should exercise caution before prescribing ixekizumab as it seems to induce and exacerbate IBD.
| S-EPMC6244035 | biostudies-other
Project description:BackgroundReal-world comparative benefits and risks of infliximab (IFX) and adalimumab (ADA) in patients with ulcerative colitis (UC) are unclear.AimTo evaluate the comparative effectiveness and safety of IFX and ADA in patients with UC who were new users of anti-TNF agents.MethodsUsing an administrative claims database (Optum Labs Data Warehouse), we identified patients who received first anti-TNF (IFX, ADA) prescription after a 12-month period without any anti-TNF treatment (baseline), and with a minimum 6-month follow-up after anti-TNF initiation. Primary outcome measures were: all-cause and UC-related hospitalisation, abdominal surgery, corticosteroid use >60 days after starting anti-TNF, and serious infections. We performed 2:1 propensity-score matched Cox proportional hazard analysis, and inverse probability-of-treatment weight (IPTW) analysis, accounting for healthcare utilisation, comorbidities and use of UC-related medication.ResultsWe included 1400 new users of anti-TNF agents (age, 43 ± 15 years; 52% males), from 2006 to 2014. On propensity-score matched analysis, there was no significant difference in the risk of UC-related hospitalisation [IFX vs. ADA; adjusted hazard ratio (aHR), 1.04; 95% confidence interval (CI) 0.71-1.51], corticosteroid use (aHR, 0.85; 95% CI, 0.68-1.06) and serious infections (aHR, 0.62; 95% CI, 0.29-1.34) between IFX- and ADA-treated patients; the number of surgical events was very small. On IPTW analysis, risk of corticosteroid use was significantly lower in IFX - as compared to ADA - treated patients (aHR, 0.82; 95% CI, 0.68-0.99). Results were stable on multiple sensitivity analyses.ConclusionsIn a large retrospective cohort of patients with UC who were new users of anti-TNF agents, IFX-treated patients may have lower corticosteroid use than ADA-treated patients, but risk of hospitalisation and serious infections were comparable.
| S-EPMC4917292 | biostudies-literature
Project description:Ulcerative colitis affects approximately 146 000 people in the UK and is the most common form of inflammatory bowel disease. The majority of patients will have uncomplicated disease, but around 1 in 10 patients will develop acute severe colitis. Despite modern medical management, colectomy rates of 27% and mortality rates of 1% are still reported. Good supportive care and intravenous corticosteroids remain the mainstay of treatment, but up to one-third of patents will not respond. The Travis criteria allow early recognition of those patients failing to improve by day 3, allowing timely planning of medical rescue therapy or surgery. Rescue therapy with either infliximab or ciclosporin appears equally efficacious. Patients naive to thiopurines seem to have better colectomy-free survival rates following rescue therapy than those previously exposed. We review the published evidence behind the conventional management of acute severe ulcerative colitis.
| S-EPMC5369586 | biostudies-other
Project description:We present a 55-year-old male patient - a smoker, admitted to a Medical Institute of MVR (Ministry of the interior, Sofia, Bulgaria), on occasion of pain and swellings, located in the area of both axillae, accompanied by purulent discharge, with bloody admixtures. Bilateral localised cystic rose above the skin surface, hyperpigmented nodules interconnected with multiple fistulas, was observed within the dermatological examination, resulting in a limitation of the possibility of movement of the hands in all directions. A subjective complaint of pain was obtained on palpation. Solid bilateral axillar cicatrices - formation was also established, which additional impeded the movements of the upper limbs. The disease was generalised affecting additional inguinal, femoral and perineal areas, while at this stage the patient refused categorically eventual photo documentation of them. The diagnosis of acne inversa was made based on the available clinical and para-clinical data, as dual antibiotic therapy with Clindamycin 300 mg, two times per day was initiated for two months, in combination with rifampicin 300 mg, two times per day also for two months. This led to a significant improvement in the clinic symptoms and the patient was hospitalised for radical surgery. A surgical management of the clinical findings was planned by an interdisciplinary team including surgeons and dermatologists. The procedure was performed under general anaesthesia. After a thorough cleaning of the operative field, a radical excision of the lesion in the left axillary and para axillar region was performed, comprising the skin and subcutaneous tissue forward the fascia pectoralis. Tissue was dissected in depth in the form of number 4, thereby creating the conditions for adaptation of the initially encountered communicating with each other skin defects. Two tubular drains were placed, followed by gradual suturing of skin and subcutaneous tissue with final applying of a sterile dressing. Effective medical treatment of patients (as in our case) with severe AI is limited. Adalimumab is the first biological approved for moderate to severe AI but does not result in stable CR (cure rate). Therefore its use in a neoadjuvant setting is under investigation. Wide local excision significantly reduces pain and improves the quality of life of AI patients. While local recurrences rate is low, the satisfaction with the cosmetic results is high. The recurrence rate is dependent on the region affected and the type of surgery. While in the axillary region primary closure may be used to reduce the time to healing, anogenital AI has the lowest recurrence rate of healing by secondary intention.
| S-EPMC5535690 | biostudies-other
Project description:BackgroundAdalimumab is a fully human, monoclonal antibody against tumor necrosis factor that is approved in Western countries for the treatment of moderately to severely active ulcerative colitis (UC).MethodsThis 52-week, phase 2/3, randomized, double-blind study evaluated adalimumab for induction and maintenance treatment in 273 anti-TNF-naive Japanese patients with UC who were refractory to corticosteroids, immunomodulators, or both. Patients received placebo, adalimumab 80/40 (80 mg at week 0, then 40 mg every other week), or adalimumab 160/80 (160/80 mg at weeks 0/2, then 40 mg every other week) in addition to background UC therapy.ResultsAt week 8, remission rates were similar among treatment arms, but more patients treated with adalimumab 160/80 achieved response (placebo, 35 %; 80/40, 43 %; 160/80, 50 %; P = 0.044 for 160/80 vs placebo) and mucosal healing (placebo, 30 %; 80/40, 39 %; 160/80, 44 %; P = 0.045 for 160/80 vs placebo) compared with placebo. At week 52, more patients receiving adalimumab 40 mg every other week achieved response (18 vs 31 %; P = 0.021), remission (7 vs 23 %; P = 0.001), and mucosal healing (16 vs 29 %; P = 0.015) compared with placebo. Week 8 response to adalimumab was associated with greater rates of response (61 %), remission (46 %), and mucosal healing (57 %) at week 52 relative to the overall population. Rates of serious adverse events were similar between treatment arms.ConclusionsInduction with adalimumab 160/80 mg led to early response and mucosal healing. Maintenance adalimumab had greater rates of long-term response, remission, and mucosal healing compared with placebo. No new safety signals were identified.
| S-EPMC3925299 | biostudies-literature
Project description:BackgroundAssociations between patient-reported outcomes and mucosal healing have not been established in ulcerative colitis (UC).AimTo evaluate relationships of rectal bleeding and stool frequency with mucosal healing and quality of life (QoL) in patients with UC in two Phase 3 studies (ULTRA 1 and 2).MethodsAssociations of patient-reported rectal bleeding and stool frequency subscores with mucosal healing (Mayo endoscopy subscore = 0 or 0/1) and QoL [inflammatory bowel disease questionnaire (IBDQ)] were assessed in adalimumab-randomised patients (160/80 mg at Weeks 0/2 followed by 40 mg biweekly or weekly) at Weeks 8 (n = 433) and 52 (n = 299), and in patients with mucosal healing [endoscopy subscore = 0 (n = 17); 0/1 (n = 52)] at Weeks 8 and 52.ResultsAt Week 8, the positive predictive values (PPVs) of rectal bleeding subscore = 0, stool frequency subscore = 0 or both scores = 0 for endoscopy subscore = 0/1 were 69%, 84% and 90% respectively; all proportions increased at Week 52. Equivalent PPVs for these subscores in patients with endoscopy subscore = 0 were 26%, 37% and 46% respectively. Among patients with endoscopy subscore = 0 at Week 8, 87% reported no rectal bleeding, while only 29% reported normal stool frequency; these proportions had increased to 94% and 41% respectively, at Week 52. Among patients with mucosal healing, IBDQ scores trended highest for patients with both rectal bleeding and stool frequency subscores = 0.ConclusionsAbsence of rectal bleeding and normal stool frequency are often predictive of mucosal healing and QoL, but complete normalisation of stool frequency is encountered rarely in patients with mucosal healing.
| S-EPMC5049645 | biostudies-literature
Project description:BackgroundThe 52-week safety and efficacy of adalimumab in Japanese patients with moderately to severely active ulcerative colitis were demonstrated in a placebo-controlled phase 2/3 trial. Data from patients who enrolled in the open-label extension study are presented.MethodsRemission and response per the full Mayo score (FMS) and the partial Mayo score (PMS), remission per the Inflammatory Bowel Disease Questionnaire (IBDQ) score, corticosteroid-free remission, and mucosal healing were assessed up to week 196 (week 208 for remission/response per PMS) of adalimumab treatment in patients who received one or more doses of adalimumab with use of a hybrid nonresponder imputation (hNRI) method. Nonresponder imputation was used for missing data up to the latest possible follow-up date for each patient, followed by observed case. Adalimumab trough concentrations were reported from week 52 to week 196 of treatment. Treatment-emergent adverse events were reported for all adalimumab-treated patients.ResultsTwo hundred sixty-six patients received adalimumab. At week 196 of treatment, remission and response rates per FMS, remission and response rates per PMS, remission rate per IBDQ score, mucosal healing rate, and corticosteroid-free remission rate were 19.2%, 32.2%, 22.5%, 32.5%, 33.1%, 30.5% (hNRI), and 40.5% (17/42; as observed), respectively. Serum adalimumab concentrations remained constant in patients receiving 40 mg every other week but increased in patients who underwent dose escalation. The safety profile was consistent with that in the 52-week study.ConclusionsThe efficacy of adalimumab in Japanese patients with moderately to severely active ulcerative colitis was maintained for up to 4 years of treatment. No new safety signals were observed.
| S-EPMC5569655 | biostudies-literature