 |
66 Diseases |  |
3 Trials |
|
3 Trials |  |
89 News |  |
| 12» |
- | Raptiva (efalizumab) / Roche, EMD Serono, Xoma
Preclinical, Journal: PBPK-based translation from preclinical species to humans for the full-size IgG therapeutic efalizumab. (Pubmed Central) - Oct 16, 2024
In this project, we compared the pharmacokinetics of a therapeutic protein in rabbit, NHP and human using an open PBPK modeling platform (Open Systems Pharmacology Suite, http://www.open-systems-pharmacology.org). Our findings could support similar translatory studies for first in human dose predictions in the future.
- Tremfya (guselkumab) / J&J
Guselkumab-associated bullous pemhigoid in a psoriasis patient: A case report. (Poster Area) - Aug 5, 2024 - Abstract #EADV2024EADV_1935;
Our findings could support similar translatory studies for first in human dose predictions in the future. This case shows the rare side effect of the development of DBP in a patient being treated with guselkumab.
- || Review, Journal: Effect of Biologic Therapies on Airway Hyperresponsiveness and Allergic Response: A Systematic Literature Review. (Pubmed Central) - Jul 27, 2023
No dupilumab or reslizumab studies were identified...These findings provide insights into AHR mechanisms and the precise effects of asthma biologics. Furthermore, findings suggest that tezepelumab broadly targets allergen-specific and non-allergic forms of AHR, and the underlying cells and mediators involved in asthma.
- | Raptiva (efalizumab) / Roche, EMD Serono, Xoma, Nulojix (belatacept) / BMS
Journal: A Multi-Modal Approach to Islet and Pancreas Transplantation With Calcineurin-Sparing Immunosuppression Maintains Long-Term Insulin Independence in Patients With Type I Diabetes. (Pubmed Central) - Jun 30, 2023
In our series, repeat islet transplant is ineffective at maintaining long-term insulin independence. PAI results in durable insulin independence but is associated with impaired renal function secondary to CNI dependence.
- || Psoralen / EMD Serono, Raptiva (efalizumab) / Roche, EMD Serono, Xoma
Review, Journal: Different Treatment Modalities of Oral Lichen Planus-A Narrative Review. (Pubmed Central) - Jan 21, 2023
Some of the therapies mentioned are tacrolimus, efalizumab, dapson, interferon, retinoic acid, photochemotherapy with psoralen and ultraviolet A rays (PUVA), aloe vera, antimalarials, antibiotics and others. These therapies only partially meet the properties of efficacy and safety of use, thus justifying the continuous search and testing of new treatment methods.
- || Herceptin (trastuzumab) / Roche, Raptiva (efalizumab) / Roche, EMD Serono, Xoma
PK/PD data, Journal: Toward Systems-Informed Models for Biologics Disposition: Covariates of the Abundance of the Neonatal Fc Receptor (FcRn) in Human Tissues and Implications for Pharmacokinetic Modelling. (Pubmed Central) - Jan 11, 2023
FcRn mRNA in plasma-derived exosomes correlated moderately with protein abundance in matching liver tissue, opening the possibility of use as a potential clinical tool. Predicted effects of trends in FcRn abundance in healthy and disease (cancer and psoriasis) populations using trastuzumab and efalizumab PBPK models were in line with clinical observations, and global sensitivity analysis revealed endogenous IgG plasma concentration and tissue FcRn abundance as key systems parameters influencing exposure to Fc-conjugated biologics.
- || Review, Journal: Bullous pemphigoid induced by biologic drugs in psoriasis: a systematic review. (Pubmed Central) - Nov 10, 2022
A close monitoring of skin condition is highly advisable in patients receiving biologic therapies for psoriasis. Knowledge of BIBP is of great importance to determine the preventive measures and select optimal treatment options.
- || Kesimpta (ofatumumab subcutaneous) / Novartis, Genmab
Review, Journal: Progressive multifocal leukoencephalopathy in anti-CD20 and other monoclonal antibody (mAb) therapies used in multiple sclerosis: A review. (Pubmed Central) - Oct 26, 2022
In fact, PML has been witnessed with several mAbs, including natalizumab in multiple sclerosis, rituximab for lymphoma or lupus, efalizumab for psoriasis, and ofatumumab in leukemia; this leads us to the risk reassessment of PML due to treatment-induced immunosuppression...This article aims to review the relationship between the incidence of PML and all four mAbs used in the treatment of MS. Currently, at least 18 FDA-approved medications carry label warnings for PML;to this date, no treatment has been convincingly effective.
- Biologic-induced photosensitivity: a case of three () - Jun 23, 2022 - Abstract #BAD2022BAD_653;
Dupilumab and secukinumab target moderate-to-severe atopic dermatitis and plaque psoriasis, respectively...In the autumn months, dupilumab was stopped owing to worsening of the rash despite sun protection and managing her rosacea with brimonidine...Furthermore, the patient had not reported photosensitivity on previous biologics: etanercept, adalimumab, infliximab, efalizumab and ustekinumab...Bloods and autoimmune screen were unremarkable. The patient is reluctant to stop vedolizumab as it is the only biologic that controls her UC.
- Raptiva (efalizumab) / Roche, EMD Serono, Xoma, Nulojix (belatacept) / BMS
Long-Term Insulin Independence Achieved by a Multimodal Approach to Beta-Cell Replacement in Patients with Type I Diabetes (Hynes Halls C & D: Board No. B250) - May 20, 2022 - Abstract #ATC2022ATC_2635;
In our series, repeat islet transplant is ineffective at restoring insulin independence. PAI results in durable insulin independence but was associated with impaired renal function in 1/3 of recipients secondary to CNI dependence.
- | Journal: Construction of miRNA-regulated drug-pathway network to screen drug repurposing candidates for multiple sclerosis. (Pubmed Central) - Apr 7, 2022
We analyzed the properties of the miRNA-regulated drug-pathway network through genes and uncovered a number of novel MS agents by assessing their respective Z-values.A total of 20 likely drug candidates were identified, including human immunoglobulin, aspirin, alemtuzumab, minocycline, abciximab, alefacept, palivizumab, bevacizumab, efalizumab, tositumomab, minocycline, etanercept, catumaxomab, and sarilumab. Each of these agents were then explored with regards to their likely mechanism of action in treating MS.The current investigation provides a fresh perspective on MS biological mechanisms as well as likely treatment strategies.
- || Enbrel (etanercept) / Pfizer, Amgen, Humira (adalimumab) / Eisai, AbbVie, Tremfya (guselkumab) / J&J
Clinical, Review, Journal: Guselkumab-associated bullous pemphigoid in a psoriasis patient: a case report and review of the literature. (Pubmed Central) - Apr 2, 2022
Conversely, DBP after guselkumab therapy for psoriasis has never been reported in published studies. We highlight the need to face and document increasing, though rare, side effects of biologic therapies, as new biologic molecules are being constantly developed and administered to psoriatic patients, to promptly interrupt treatment when needed.
- | Journal: Identification of Molecular Signatures and Candidate Drugs in Vascular Dementia by Bioinformatics Analyses. (Pubmed Central) - Mar 1, 2022
Hub gene-drug interaction analysis found four drugs (maraviroc, cenicriviroc, PF-04634817, and efalizumab) that could be potential drugs for VaD treatment. Together, our results may contribute to understanding the underlying mechanisms in VaD and provide potential targets and drugs for therapeutic intervention.
- | Remicade (infliximab) / Merck (MSD), Mitsubishi Tanabe, J&J, Enbrel (etanercept) / Pfizer, Amgen, Humira (adalimumab) / Eisai, AbbVie
Journal, Real-world evidence: Biologic Therapy for Moderate to Severe Psoriasis. Real-World Follow-up of Patients Who Initiated Biologic Therapy at Least 10 Years Ago. (Pubmed Central) - Mar 1, 2022
Together, our results may contribute to understanding the underlying mechanisms in VaD and provide potential targets and drugs for therapeutic intervention. This study in the real-world-setting shows maintenance of long-term efficacy and safety of biologic therapy in patients with moderate to severe plaque psoriasis in daily practice who initiated biologic therapy 10 years ago.
- Effect of Biologics on Allergic Response and Airway Hyperresponsiveness: A Systematic Literature Review (Area I, Hall F (North Building, Exhibition Level), Moscone Center) - Feb 19, 2022 - Abstract #ATS2022ATS_823;
Tezepelumab also consistently attenuated nonspecific AHR to methacholine or mannitol. These findings provide further insight into the mechanisms of AHR and the clinical benefits of asthma biologics and suggest that tezepelumab may broadly target mediators or cells involved in asthma inflammation.
- || Raptiva (efalizumab) / Roche, EMD Serono, Xoma, levamisole / Generic mfg.
Talking about tragedies? Levamisole,Sparfloxicin,Temafloxicin,Grepafloxicin, Vioxx,Rezulin,Propulsid,Posicor,Hismanal,Duract,Bextra,Baycol,Selacryn,Seldane,Raptiva. This is just a short list of some of the drug "tragedies" that had RCT prior to release. Again I am biased. (Twitter) - Feb 18, 2022
- Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Risankizumab-induced rosacea-like dermatitis () - Nov 11, 2021 - Abstract #ISDS2021ISDS_200;
She had already been treated with phototherapy, methotrexate, cyclosporine, efalizumab 15-year before and was currently using only high-potency topical corticosteroids...It was precribed a single dose of ivermectin, fexofenadine for 7 days, topical 0.75 metronidazole for 3 months, fexofenadine for 7 days and photoprotection...Although there are less common possible triggering factors, the aim of this case is to presente the current knowledge on the association between of certain drugs and rosacea. Moreover, risankizumab improved health-related quality of life for psoriasis control and was generally well tolerated.
- || Remicade (infliximab) / Merck (MSD), Mitsubishi Tanabe, J&J, Enbrel (etanercept) / Pfizer, Amgen, Humira (adalimumab) / Eisai, AbbVie
Retrospective data, Review, Journal: Risk of herpes zoster associated with biological therapies for psoriasis and psoriatic arthritis: A systematic review and meta-analysis. (Pubmed Central) - Oct 16, 2021
Moreover, risankizumab improved health-related quality of life for psoriasis control and was generally well tolerated. Few RCTs have reported HZ incidents; thus, our results require confirmation via large-scale RCTs.
- Tysabri (natalizumab) / Biogen, Raptiva (efalizumab) / Roche, EMD Serono, Xoma
[VIRTUAL] Progressive Multifocal Leukoencephalopathy in a Teenager with Juvenile Dermatomyositis () - Sep 25, 2021 - Abstract #AAPNCE2021AAP_NCE_1701;
Differentiating PML from new onset or exacerbation of CNS complications of underlying auto-immune conditions is challenging. PML should be considered in patients with unexplained subacute progressive focal and diffuse neurologic deficits, especially if their clinical or radiologic status worsens with increased intensity of immunosuppressive therapy.
- | Tysabri (natalizumab) / Biogen, Raptiva (efalizumab) / Roche, EMD Serono, Xoma
Journal: Anti-αLβ2 antibodies reveal novel endocytotic crossmodulatory functionality. (Pubmed Central) - Jun 22, 2021
The newly described phenomenon may be of relevance to other therapeutic antibodies targeting cluster-forming receptors. Thus, it should be on the radar of pharmacologists investigating such antibodies.
- || Remicade (infliximab) / Merck (MSD), Mitsubishi Tanabe, J&J, Enbrel (etanercept) / Pfizer, Amgen, Humira (adalimumab) / Eisai, AbbVie
Retrospective data, Review: Risk of Herpes Zoster Among Psoriasis Patients Taking Biologics: A Network Meta-Analysis of Cohort Studies. (Pubmed Central) - Jun 22, 2021
Of note, the negative findings of our study do not mean the unnecessity of vaccination. More efforts must be taken to further determine HZ risk of different therapeutic strategies.
- || Stelara (ustekinumab) / J&J
Clinical, Review, Journal: Therapeutic management in pediatric alopecia areata: a systematic review. (Pubmed Central) - May 21, 2021
On the basis of the limited data available glucocorticosteroids (systemic, intralesional or topical) and JAK inhibitors (systemic or topical) may be considered the best documented and most effective treatment options in alopecia areata in children. There are no sufficient pediatric data to compare treatment safety and relapse rates in these therapeutic modalities.
- | Xeljanz (tofacitinib) / Pfizer, Marche Polytechnic University
Journal: Evolution of the inclusion/exclusion criteria and primary endpoints in pivotal trials of biologics and small oral molecules for the treatment of psoriasis. (Pubmed Central) - Jan 23, 2021
Small oral molecules are the future of affordable effective treatment for psoriasis, but the safety concerns must be overcome as reflected by their more stringent exclusion criteria. More biologic switch data and inclusion of patients previously excluded, e.g. viral hepatitis, are still needed.
- Xeljanz (tofacitinib) / Pfizer, Marche Polytechnic University, Tremfya (guselkumab) / J&J, Cosentyx (secukinumab) / Novartis
[VIRTUAL] Efficacy of guselkumab versus secukinumab in patients with moderate-to-severe plaque psoriasis in subgroups defined by previous psoriasis medication history: results from the ECLIPSE study () - Dec 6, 2020 - Abstract #SIDEMAST2020SIDEMAST_10;
Prior biologic therapies included tumor necrosis factor-α inhibitors, interleukin (IL)-12/IL-23 inhibitors, IL-23 inhibitors, IL-17 inhibitors, alefacept, or efalizumab... Treatment with guselkumab demonstrated numerically higher clinical responses at Week 48 irrespective of previous PsO medication history
- Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, methotrexate / Generic mfg., Raptiva (efalizumab) / Roche, EMD Serono, Xoma
[VIRTUAL] Biosimilar brand switch associated with loss of efficacy in psoriasis repaired by return to originator brand () - Sep 9, 2020 - Abstract #BAD2020BAD_142;
Low values reflect patients switched from efalizumab after it was withdrawn...He achieved excellent clinical control (PASI 2.4) for 6 years before being switched to Remsima...A 50‐year‐old woman with severe psoriasis (PASI 29, DLQI 21) refractory to three previous biologics, was commenced on Remicade with methotrexate (7.5 mg) on the day of infusion...In some individuals there may be loss of efficacy with brand switching. In such cases reverting to the originator brand may restore efficacy.
- [VIRTUAL] Pathogenesis of severe drug reactions (p.570) - Aug 2, 2020 - Abstract #WAC2020WAC_194;
Hemolytic anemia (beta lactams, rifampin, sulphonamides)...DRESS (antiepileptics, allopurinol, sulphonamides, minocycline, dapsone, sulfasalazine, abacavir, nepiravine, hydroxychloroquine, vancomycin, celecoxib, efalizumab), Type 4c: CD8+cells, NK cells, NKT cellsT cellsSJS/TEN, (allopurinol), bullous exanthema, fixed drug eruptions (tetracyclines, NSAIDS, carbamazepine, TMP/SMZ, gemfibrozil, imidazoles), hepatitis (flucloxacilline)Type 4d: T cells, CXCL8, GM-CSF...AGEP (hydroxychloroquine). Three models of immune activation have been described in allergic reactions to drugs
- Fumaderm (dimethyl fumarate) / Biogen
[VIRTUAL] John Cunningham Virus seroconversion in a psoriasis cohort () - Jun 20, 2020 - Abstract #AADVMX2020AAD-VMX_327;
This year we reassessed 54 patients from the original cohort; 50% were seropositive. 7 patients had seroconverted bringing up a total of 63%.
- | Entyvio (vedolizumab) / Takeda
Review, Journal: Interfering with leukocyte trafficking in Crohn's disease. (Pubmed Central) - Nov 14, 2019
Oral and subcutaneous therapies are in development. The safety, efficacy and practice points of licensed drugs are discussed, in addition to initial results from therapeutic trials.
- | Clinical, Journal, Adverse events: Adverse Events in Patients With Rheumatoid Arthritis and Psoriatic Arthritis Receiving Long-Term Biological Agents in a Real-Life Setting. (Pubmed Central) - Oct 3, 2019
These data showed the early biological experience in Brazil that were associated with ADRs, withdrawals due to ADRs and SAEs. The quantification of adverse effects (serious or nonserious) considering close monitoring and patients' perceptions are increasingly important for future decision-making.
- | Amevive (alefacept) / Astellas, Raptiva (efalizumab) / Roche, EMD Serono, Xoma
Review, Journal: Systemic treatments for alopecia areata: A systematic review. (Pubmed Central) - Jun 7, 2019
Evidence does not support the use of oral zinc sulphate, alefacept and efalizumab. Future RCTs should be adequately powered and employ clearly defined clinical response endpoints to allow future meta-analyses.
- Raptiva (efalizumab) / Roche, EMD Serono, Xoma
Enrollment change, Combination therapy: A Study to Evaluate Efalizumab Compared With Cyclosporine As an Immunosuppressant Regimen in De Novo Renal Transplantation (clinicaltrials.gov) - Jun 22, 2017
P2/3, N=0, Withdrawn, Sponsor: Genentech, Inc.
Future RCTs should be adequately powered and employ clearly defined clinical response endpoints to allow future meta-analyses. N=200 --> 0
- | Raptiva (efalizumab) / Roche, EMD Serono, Xoma
Phase classification: A Multicentre, Open Label Phase IIIb/IV Study of Subcutaneously Administered Raptiva in the Treatment of Adult Subjects With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - Nov 7, 2016
P3b/4, N=189, Completed, Sponsor: Merck KGaA
N=200 --> 0 Phase classification: P4 --> P3b/4
- Raptiva (efalizumab) / Roche, EMD Serono, Xoma, Lucentis (ranibizumab) / Roche, Novartis
Enrollment change: Combined aPproach to Treatment Using Ranibizumab and Efalizumab for Diabetic Macular Edema Study: The CAPTURE DME Study (clinicaltrials.gov) - Aug 26, 2016
P1, N=0, Withdrawn, Sponsor: Johns Hopkins University
Phase classification: P4 --> P3b/4 N=72 --> 0
- Raptiva (efalizumab) / Roche, EMD Serono, Xoma
Enrollment change: Efalizumab in the Treatment of Alopecia, Phase II (clinicaltrials.gov) - Jun 15, 2016
P2, N=0, Withdrawn, Sponsor: Northwestern University
N=72 --> 0 N=18 --> 0
- |||| Raptiva (efalizumab) / Roche, EMD Serono, Xoma
Trial completion, Combination therapy: A Study to Evaluate Raptiva in Combination With Topical Psoriasis Therapies (clinicaltrials.gov) - Feb 27, 2016
P4, N=300, Completed, Sponsor: Genentech, Inc.
N=18 --> 0 No longer recruiting --> Completed
- ||||||| Raptiva (efalizumab) / Roche, EMD Serono, Xoma
Trial completion: A Study to Evaluate the Safety of Raptiva in Adults With Plaque Psoriasis Previously Enrolled in Study ACD2600g (clinicaltrials.gov) - Feb 27, 2016
P3, N=450, Completed, Sponsor: Genentech, Inc.
No longer recruiting --> Completed No longer recruiting --> Completed
- Raptiva (efalizumab) / Roche, EMD Serono, Xoma
Trial initiation date, Trial termination: Efalizumab in Treating Patients With Graft-Versus-Host Disease of the Skin That Did Not Respond to Previous Steroids (clinicaltrials.gov) - Jan 22, 2016
P=N/A, N=2, Terminated, Sponsor: UNC Lineberger Comprehensive Cancer Center
No longer recruiting --> Completed Initiation date: May 2007 --> Dec 2006 | Completed --> Terminated; insufficient accrual/funding withdrawn
- Raptiva (efalizumab) / Roche, EMD Serono, Xoma, Lucentis (ranibizumab) / Roche, Novartis
Enrollment change: SEIRA: Study of Efalizumab Combined With Intravitreal Ranibizumab in the Treatment of Age-Related Macular Degeneration (clinicaltrials.gov) - Jul 9, 2015
P1, N=0, Withdrawn, Sponsor: Vitreous -Retina- Macula Consultants of New York
Initiation date: May 2007 --> Dec 2006 | Completed --> Terminated; insufficient accrual/funding withdrawn N=10 --> 0
- Raptiva (efalizumab) / Roche, EMD Serono, Xoma
Enrollment change: RESTORE: Raptiva (clinicaltrials.gov) - Aug 29, 2014
P4, N=294, Terminated, Sponsor: Merck KGaA
N=10 --> 0 N=900 --> 294
- Raptiva (efalizumab) / Roche, EMD Serono, Xoma
Trial primary completion date: BRiTE: Beta Cell Rescue in New Onset Type 1 Diabetes With Efalizumab (clinicaltrials.gov) - May 8, 2014
P2, N=0, Withdrawn, Sponsor: Emory University
N=900 --> 294 Trial primary completion date: Sep 2013 --> Nov 2009
- Raptiva (efalizumab) / Roche, EMD Serono, Xoma
Trial withdrawal: BRiTE: Beta Cell Rescue in New Onset Type 1 Diabetes With Efalizumab (clinicaltrials.gov) - May 8, 2014
P2, N=0, Withdrawn, Sponsor: Emory University
Trial primary completion date: Sep 2013 --> Nov 2009 Terminated --> Withdrawn
- Raptiva (efalizumab) / Roche, EMD Serono, Xoma
Trial completion date: BRiTE: Beta Cell Rescue in New Onset Type 1 Diabetes With Efalizumab (clinicaltrials.gov) - May 8, 2014
P2, N=0, Withdrawn, Sponsor: Emory University
Terminated --> Withdrawn Trial completion date: Sep 2013 --> Nov 2009
- | Raptiva (efalizumab) / Roche, EMD Serono, Xoma
Trial completion: An Observational Study of the Use and Safety of Raptiva During Pregnancy (FOLLOW) (clinicaltrials.gov) - Feb 22, 2014
P4, N=18, Completed, Sponsor: Genentech
Trial completion date: Sep 2013 --> Nov 2009 Recruiting --> Completed
- Raptiva (efalizumab) / Roche, EMD Serono, Xoma
Trial withdrawal: Pilot Trial to Assess Effect of CNI Conversion of Efalizumab on T Reg Cells (clinicaltrials.gov) - May 12, 2013
P1/2, N=0, Withdrawn, Sponsor: University of California, San Francisco
Recruiting --> Completed Terminated --> Withdrawn
- Raptiva (efalizumab) / Roche, EMD Serono, Xoma
Enrollment change: Pilot Trial to Assess Effect of CNI Conversion of Efalizumab on T Reg Cells (clinicaltrials.gov) - May 12, 2013
P1/2, N=0, Withdrawn, Sponsor: University of California, San Francisco
Terminated --> Withdrawn N=10 --> 0
- Raptiva (efalizumab) / Roche, EMD Serono, Xoma
Enrollment change: Efalizumab in Treating Patients With Graft-Versus-Host Disease of the Skin That Did Not Respond to Previous Steroids (clinicaltrials.gov) - Jan 31, 2013
P=N/A, N=2, Completed, Sponsor: UNC Lineberger Comprehensive Cancer Center
N=10 --> 0 N=12 --> 2
- Thymoglobulin (anti-thymocyte globulin (rabbit)) / Sanofi, Raptiva (efalizumab) / Roche, EMD Serono, Xoma
Enrollment change: Raptiva and Sirolimus in Islet Transplantation for Type 1 Diabetes (clinicaltrials.gov) - Nov 12, 2012
P1/2, N=3, Completed, Sponsor: University of Minnesota - Clinical and Translational Science Institute
N=12 --> 2 N=10 --> 3
- Thymoglobulin (anti-thymocyte globulin (rabbit)) / Sanofi, Raptiva (efalizumab) / Roche, EMD Serono, Xoma
Trial completion: Raptiva and Sirolimus in Islet Transplantation for Type 1 Diabetes (clinicaltrials.gov) - Nov 12, 2012
P1/2, N=3, Completed, Sponsor: University of Minnesota - Clinical and Translational Science Institute
N=10 --> 3 Active, not recruiting --> Completed
- Raptiva (efalizumab) / Roche, EMD Serono, Xoma
Enrollment change: Early Conversion From Tacrolimus to Efalizumab Maintenance Therapy in Kidney Transplant Recipients (clinicaltrials.gov) - Nov 8, 2012
P1/2, N=5, Terminated, Sponsor: Emory University
Active, not recruiting --> Completed N=20 --> 5
- Raptiva (efalizumab) / Roche, EMD Serono, Xoma
Trial termination: Classification and Characterization of Patients Treated With Efalizumab for Plaque Psoriasis (clinicaltrials.gov) - Jan 17, 2012
P4, N=96, Terminated, Sponsor: Norwegian University of Science and Technology
N=20 --> 5 Recruiting --> Terminated; efalizumab was withdrawn from market; full 2 years follow-up only 14 patients